Neuromuscular Disorders

Increased incidence of Guillain-Barré syndrome corresponded closely with patterns of Zika virus disease incidence in Central and South America from April 2015 through March 2016, according to results from a new temporal and graphic analysis.

The findings show Guillain-Barré syndrome (GBS) cases increasing from 100% to nearly 900% above previously recorded baseline rates during periods of Zika virus transmission in El Salvador, the Dominican Republic, Colombia, Honduras, Suriname, Venezuela, and the Brazilian state of Bahia (N Engl J Med. 2016 Aug 31. doi: 10.1056/NEJMc1609015).

©AlexLMX/Thinkstock

The analysis of the yearlong period also revealed that declines in GBS incidence accompanied declines in Zika virus disease when and where transmission began to wane. The researchers, led by Marcos A. Espinal, MD, DrPH, of the Pan American Health Organization in Washington, did not find significant associations between co-circulation of dengue virus and GBS incidence. The study, which looked at 164,237 confirmed and suspected cases of Zika virus disease and 1,474 cases of GBS, found a 75% higher Zika virus disease incidence rate in women, which Dr. Espinal and colleagues said might be attributable to differences in health care–seeking behavior. GBS incidence, meanwhile, was 28% higher among males. The higher rate of GBS in men, the authors said, was consistent with findings from previous epidemiological studies of GBS.

While the new results did not show that Zika virus causes GBS, Dr. Espinal and colleagues wrote, they argued that they were indicative of a strong association, adding that GBS “could serve as a sentinel for Zika virus disease and other neurological disorders linked to Zika virus,” including microcephaly.

Most of the study authors worked for the Pan American Health Organization or for national health agencies in the data-contributing countries. None declared conflicts of interest.

Increased incidence of Guillain-Barré syndrome corresponded closely with patterns of Zika virus disease incidence in Central and South America from April 2015 through March 2016, according to results from a new temporal and graphic analysis.

The findings show Guillain-Barré syndrome (GBS) cases increasing from 100% to nearly 900% above previously recorded baseline rates during periods of Zika virus transmission in El Salvador, the Dominican Republic, Colombia, Honduras, Suriname, Venezuela, and the Brazilian state of Bahia (N Engl J Med. 2016 Aug 31. doi: 10.1056/NEJMc1609015).

©AlexLMX/Thinkstock

The analysis of the yearlong period also revealed that declines in GBS incidence accompanied declines in Zika virus disease when and where transmission began to wane. The researchers, led by Marcos A. Espinal, MD, DrPH, of the Pan American Health Organization in Washington, did not find significant associations between co-circulation of dengue virus and GBS incidence. The study, which looked at 164,237 confirmed and suspected cases of Zika virus disease and 1,474 cases of GBS, found a 75% higher Zika virus disease incidence rate in women, which Dr. Espinal and colleagues said might be attributable to differences in health care–seeking behavior. GBS incidence, meanwhile, was 28% higher among males. The higher rate of GBS in men, the authors said, was consistent with findings from previous epidemiological studies of GBS.

While the new results did not show that Zika virus causes GBS, Dr. Espinal and colleagues wrote, they argued that they were indicative of a strong association, adding that GBS “could serve as a sentinel for Zika virus disease and other neurological disorders linked to Zika virus,” including microcephaly.

Most of the study authors worked for the Pan American Health Organization or for national health agencies in the data-contributing countries. None declared conflicts of interest.

Increased incidence of Guillain-Barré syndrome corresponded closely with patterns of Zika virus disease incidence in Central and South America from April 2015 through March 2016, according to results from a new temporal and graphic analysis.

The findings show Guillain-Barré syndrome (GBS) cases increasing from 100% to nearly 900% above previously recorded baseline rates during periods of Zika virus transmission in El Salvador, the Dominican Republic, Colombia, Honduras, Suriname, Venezuela, and the Brazilian state of Bahia (N Engl J Med. 2016 Aug 31. doi: 10.1056/NEJMc1609015).

©AlexLMX/Thinkstock

The analysis of the yearlong period also revealed that declines in GBS incidence accompanied declines in Zika virus disease when and where transmission began to wane. The researchers, led by Marcos A. Espinal, MD, DrPH, of the Pan American Health Organization in Washington, did not find significant associations between co-circulation of dengue virus and GBS incidence. The study, which looked at 164,237 confirmed and suspected cases of Zika virus disease and 1,474 cases of GBS, found a 75% higher Zika virus disease incidence rate in women, which Dr. Espinal and colleagues said might be attributable to differences in health care–seeking behavior. GBS incidence, meanwhile, was 28% higher among males. The higher rate of GBS in men, the authors said, was consistent with findings from previous epidemiological studies of GBS.

While the new results did not show that Zika virus causes GBS, Dr. Espinal and colleagues wrote, they argued that they were indicative of a strong association, adding that GBS “could serve as a sentinel for Zika virus disease and other neurological disorders linked to Zika virus,” including microcephaly.

Most of the study authors worked for the Pan American Health Organization or for national health agencies in the data-contributing countries. None declared conflicts of interest.

Labeling for prescription opioid pain or cough medicines and benzodiazepines will now carry the strongest available warning regarding serious side effects and death associated with their combined use, according to the Food and Drug Administration.

The new boxed warnings urge health care professionals to limit prescribing opioid pain medicines with benzodiazepines or other central nervous system depressants only to patients for whom alternative treatment options are inadequate, and to limit dosages and treatment duration to the minimum possible while achieving the desired clinical effect.

“First, the FDA is requiring companies to update their product labeling for ... benzodiazepines and opioids to include possible harms when they are used together. Second, we are requiring new or updated medication guides for these drugs reflecting those same warnings,” said Doug Throckmorton, MD, deputy director of the FDA’s Center for Drug Evaluation and Research, during a telebriefing.

Opioids will include a warning regarding prescribing with benzodiazepines and other central nervous system depressants, including alcohol. Benzodiazepines will include a warning regarding prescribing with opioids.

In addition, the FDA has issued a safety communication to “warn the public about the serious risk of taking these products together to help make doctors more cautious and patients better informed,” Dr. Throckmorton said.

The action comes amid ongoing efforts to address an epidemic of opioid addiction across the United States, and in response to a first-of-its-kind “citizen petition” calling for the boxed warnings.

A coalition of health officials from multiple cities, states, and U.S. territories initiated that petition in February, and thousands of concerned community members started an additional online petition. Those petitions were in response to both the increasing combined use of opioids and benzodiazepines and a concomitant increase in the risk of serious side effects and deaths associated with their combined use, according to Baltimore City Health Commissioner Leana Wen, MD.

As an emergency physician, Dr. Wen said that she has seen firsthand the alarming trends; one in three unintentional overdose deaths from prescribed opioids also involve benzodiazepines, she noted.

“In my state of Maryland in 2014, benzodiazepines were associated with 19% of prescription opioid deaths, and 59% of benzodiazepine-associated deaths involved prescription opioids. We also noted the growing biological evidence that combining these medications caused sleepiness and slowed breathing, increasing the likelihood of a fatal overdose,” she said.

Dr. Throckmorton further noted that emergency department visits and deaths involving patients prescribed both opioids and benzodiazepines have increased significantly over time. From 2004 to 2011, the rate of nonmedical use–related emergency department visits increased significantly each year, and overdose deaths involving both drug classes during that period nearly tripled on an annual basis.

“Communities have been seeing this trend for some time, but ultimately we needed data in order to act today,” FDA Commissioner Robert Califf, MD, said during the telebriefing.

The current action is just “one part of a larger effort to address this epidemic.

“We remain focused and deeply committed to contributing to the comprehensive effort to address the opioid epidemic,” Dr. Califf said. The FDA “will continue to monitor these products carefully and take additional actions as needed, and will share updates with the public as necessary as we work to address this public health crisis.”

Dr. Califf noted that the current action is part of the FDA’s Opioids Action Plan, which is “importantly not meant just to cover illicit or abusive use of opioids.”

“So, you’ll be hearing a lot more from us, because this is a national crisis that is not going away. We’re making progress on the prescribing, and we’re seeing a reduction in the use of opioids now,” he noted. “But we’re still seeing many overdoses.

“This is a continuum, and we’ll continue to try to do everything we can to address the epidemic,” Dr. Califf concluded.

[email protected]

Labeling for prescription opioid pain or cough medicines and benzodiazepines will now carry the strongest available warning regarding serious side effects and death associated with their combined use, according to the Food and Drug Administration.

The new boxed warnings urge health care professionals to limit prescribing opioid pain medicines with benzodiazepines or other central nervous system depressants only to patients for whom alternative treatment options are inadequate, and to limit dosages and treatment duration to the minimum possible while achieving the desired clinical effect.

“First, the FDA is requiring companies to update their product labeling for ... benzodiazepines and opioids to include possible harms when they are used together. Second, we are requiring new or updated medication guides for these drugs reflecting those same warnings,” said Doug Throckmorton, MD, deputy director of the FDA’s Center for Drug Evaluation and Research, during a telebriefing.

Opioids will include a warning regarding prescribing with benzodiazepines and other central nervous system depressants, including alcohol. Benzodiazepines will include a warning regarding prescribing with opioids.

In addition, the FDA has issued a safety communication to “warn the public about the serious risk of taking these products together to help make doctors more cautious and patients better informed,” Dr. Throckmorton said.

The action comes amid ongoing efforts to address an epidemic of opioid addiction across the United States, and in response to a first-of-its-kind “citizen petition” calling for the boxed warnings.

A coalition of health officials from multiple cities, states, and U.S. territories initiated that petition in February, and thousands of concerned community members started an additional online petition. Those petitions were in response to both the increasing combined use of opioids and benzodiazepines and a concomitant increase in the risk of serious side effects and deaths associated with their combined use, according to Baltimore City Health Commissioner Leana Wen, MD.

As an emergency physician, Dr. Wen said that she has seen firsthand the alarming trends; one in three unintentional overdose deaths from prescribed opioids also involve benzodiazepines, she noted.

“In my state of Maryland in 2014, benzodiazepines were associated with 19% of prescription opioid deaths, and 59% of benzodiazepine-associated deaths involved prescription opioids. We also noted the growing biological evidence that combining these medications caused sleepiness and slowed breathing, increasing the likelihood of a fatal overdose,” she said.

Dr. Throckmorton further noted that emergency department visits and deaths involving patients prescribed both opioids and benzodiazepines have increased significantly over time. From 2004 to 2011, the rate of nonmedical use–related emergency department visits increased significantly each year, and overdose deaths involving both drug classes during that period nearly tripled on an annual basis.

“Communities have been seeing this trend for some time, but ultimately we needed data in order to act today,” FDA Commissioner Robert Califf, MD, said during the telebriefing.

The current action is just “one part of a larger effort to address this epidemic.

“We remain focused and deeply committed to contributing to the comprehensive effort to address the opioid epidemic,” Dr. Califf said. The FDA “will continue to monitor these products carefully and take additional actions as needed, and will share updates with the public as necessary as we work to address this public health crisis.”

Dr. Califf noted that the current action is part of the FDA’s Opioids Action Plan, which is “importantly not meant just to cover illicit or abusive use of opioids.”

“So, you’ll be hearing a lot more from us, because this is a national crisis that is not going away. We’re making progress on the prescribing, and we’re seeing a reduction in the use of opioids now,” he noted. “But we’re still seeing many overdoses.

“This is a continuum, and we’ll continue to try to do everything we can to address the epidemic,” Dr. Califf concluded.

[email protected]

Labeling for prescription opioid pain or cough medicines and benzodiazepines will now carry the strongest available warning regarding serious side effects and death associated with their combined use, according to the Food and Drug Administration.

The new boxed warnings urge health care professionals to limit prescribing opioid pain medicines with benzodiazepines or other central nervous system depressants only to patients for whom alternative treatment options are inadequate, and to limit dosages and treatment duration to the minimum possible while achieving the desired clinical effect.

“First, the FDA is requiring companies to update their product labeling for ... benzodiazepines and opioids to include possible harms when they are used together. Second, we are requiring new or updated medication guides for these drugs reflecting those same warnings,” said Doug Throckmorton, MD, deputy director of the FDA’s Center for Drug Evaluation and Research, during a telebriefing.

Opioids will include a warning regarding prescribing with benzodiazepines and other central nervous system depressants, including alcohol. Benzodiazepines will include a warning regarding prescribing with opioids.

In addition, the FDA has issued a safety communication to “warn the public about the serious risk of taking these products together to help make doctors more cautious and patients better informed,” Dr. Throckmorton said.

The action comes amid ongoing efforts to address an epidemic of opioid addiction across the United States, and in response to a first-of-its-kind “citizen petition” calling for the boxed warnings.

A coalition of health officials from multiple cities, states, and U.S. territories initiated that petition in February, and thousands of concerned community members started an additional online petition. Those petitions were in response to both the increasing combined use of opioids and benzodiazepines and a concomitant increase in the risk of serious side effects and deaths associated with their combined use, according to Baltimore City Health Commissioner Leana Wen, MD.

As an emergency physician, Dr. Wen said that she has seen firsthand the alarming trends; one in three unintentional overdose deaths from prescribed opioids also involve benzodiazepines, she noted.

“In my state of Maryland in 2014, benzodiazepines were associated with 19% of prescription opioid deaths, and 59% of benzodiazepine-associated deaths involved prescription opioids. We also noted the growing biological evidence that combining these medications caused sleepiness and slowed breathing, increasing the likelihood of a fatal overdose,” she said.

Dr. Throckmorton further noted that emergency department visits and deaths involving patients prescribed both opioids and benzodiazepines have increased significantly over time. From 2004 to 2011, the rate of nonmedical use–related emergency department visits increased significantly each year, and overdose deaths involving both drug classes during that period nearly tripled on an annual basis.

“Communities have been seeing this trend for some time, but ultimately we needed data in order to act today,” FDA Commissioner Robert Califf, MD, said during the telebriefing.

The current action is just “one part of a larger effort to address this epidemic.

“We remain focused and deeply committed to contributing to the comprehensive effort to address the opioid epidemic,” Dr. Califf said. The FDA “will continue to monitor these products carefully and take additional actions as needed, and will share updates with the public as necessary as we work to address this public health crisis.”

Dr. Califf noted that the current action is part of the FDA’s Opioids Action Plan, which is “importantly not meant just to cover illicit or abusive use of opioids.”

“So, you’ll be hearing a lot more from us, because this is a national crisis that is not going away. We’re making progress on the prescribing, and we’re seeing a reduction in the use of opioids now,” he noted. “But we’re still seeing many overdoses.

“This is a continuum, and we’ll continue to try to do everything we can to address the epidemic,” Dr. Califf concluded.

[email protected]

Officials at the Centers for Disease Control and Prevention have confirmed a case of Zika virus infection in a nonpregnant Maryland woman who likely contracted the virus through sexual intercourse with her asymptomatic male partner.

“To date, only one other case has been reported in which a man without symptoms might have sexually transmitted Zika virus to his female partner,” Richard B. Brooks, MD, and his colleagues wrote Aug. 26 in the Morbidity and Mortality Weekly Report (doi:10.15585/mmwr.mm6534e2). “However, in that reported case, both the man and the woman had traveled to a country with ongoing Zika virus transmission where they were likely exposed to mosquitoes.”

In the current case, the couple had condomless vaginal sex 10 days and 14 days after his return from the Dominican Republic, along with oral sex on day 14. Two days after the last encounter, the woman began exhibiting symptoms of Zika virus infection, namely, a maculopapular rash and a fever. She sought medical care 3 days later (19 days after her partner returned to the United States). She had no other sexual partners during this time. Meanwhile, the male sex partner reported no symptoms of a Zika virus infection, other than simply being tired from his recent travel.

“The findings in this report indicate that it might be appropriate to consider persons who have condomless sex with partners returning from areas with ongoing Zika virus transmission as exposed to Zika virus, regardless of whether the returning traveler reports symptoms of Zika virus infection,” the researchers wrote.

©Tomasz Gierygowski/thinkstockphotos.com

Transmission of Zika virus through blood transfusions is also a growing concern, particularly if an asymptomatic individual donated blood.

On Aug. 26, the Food and Drug Administration announced recommendations to test all donated blood and blood components across the United States and its territories for the Zika virus, to mitigate the chances of transmitting the virus through transfusions. In February, the FDA first issued guidance recommending that only areas with active Zika virus transmission screen donated blood.

“As new scientific and epidemiological information regarding Zika virus has become available, it’s clear that additional precautionary measures are necessary,” Luciana Borio, MD, FDA’s acting chief scientist, said in a statement. “We are issuing revised guidance for immediate implementation in order to help maintain the safety of the U.S. blood supply.”

In a conference call with reporters, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said that while there have not yet been any confirmed cases of such transmission, donors and health care workers must be vigilant. “Given the frequency of travel of individuals within the United States, there is the risk that people without symptoms who are infected with Zika virus could potentially donate blood and thereby transmit Zika virus,” he said.

The CDC also published new numbers on Guillain-Barré syndrome (GBS), which has been on the rise in countries affected by Zika virus.

Individuals who began exhibiting any neurologic symptoms between Jan. 1, 2016, and July 31, 2016, and were suspected of possible GBS total 56. Of those 56 patients, 34 (61%) were found to have evidence of either Zika or another related flavivirus. Ten (18%) of those 56 were confirmed to have Zika virus, and 1 patient who received treatment for GBS died of septic shock. Thirty (88%) of the 34 found to have evidence of flavivirus also reported having an acute illness of some kind before the onset of neurologic symptoms. The figures come from the GBS Passive Surveillance System (MMWR. 2016 Aug 26. doi:10.15585/mmwr.mm6534e1).

“Persons with signs or symptoms consistent with GBS should promptly seek medical attention,” the CDC urged. “Health care providers who evaluate patients with neurologic illnesses should consider GBS and report suspected cases to public health authorities. Residents of and travelers to Puerto Rico are advised to follow existing recommendations for prevention of Zika virus infection.”

[email protected]

Officials at the Centers for Disease Control and Prevention have confirmed a case of Zika virus infection in a nonpregnant Maryland woman who likely contracted the virus through sexual intercourse with her asymptomatic male partner.

“To date, only one other case has been reported in which a man without symptoms might have sexually transmitted Zika virus to his female partner,” Richard B. Brooks, MD, and his colleagues wrote Aug. 26 in the Morbidity and Mortality Weekly Report (doi:10.15585/mmwr.mm6534e2). “However, in that reported case, both the man and the woman had traveled to a country with ongoing Zika virus transmission where they were likely exposed to mosquitoes.”

In the current case, the couple had condomless vaginal sex 10 days and 14 days after his return from the Dominican Republic, along with oral sex on day 14. Two days after the last encounter, the woman began exhibiting symptoms of Zika virus infection, namely, a maculopapular rash and a fever. She sought medical care 3 days later (19 days after her partner returned to the United States). She had no other sexual partners during this time. Meanwhile, the male sex partner reported no symptoms of a Zika virus infection, other than simply being tired from his recent travel.

“The findings in this report indicate that it might be appropriate to consider persons who have condomless sex with partners returning from areas with ongoing Zika virus transmission as exposed to Zika virus, regardless of whether the returning traveler reports symptoms of Zika virus infection,” the researchers wrote.

©Tomasz Gierygowski/thinkstockphotos.com

Transmission of Zika virus through blood transfusions is also a growing concern, particularly if an asymptomatic individual donated blood.

On Aug. 26, the Food and Drug Administration announced recommendations to test all donated blood and blood components across the United States and its territories for the Zika virus, to mitigate the chances of transmitting the virus through transfusions. In February, the FDA first issued guidance recommending that only areas with active Zika virus transmission screen donated blood.

“As new scientific and epidemiological information regarding Zika virus has become available, it’s clear that additional precautionary measures are necessary,” Luciana Borio, MD, FDA’s acting chief scientist, said in a statement. “We are issuing revised guidance for immediate implementation in order to help maintain the safety of the U.S. blood supply.”

In a conference call with reporters, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said that while there have not yet been any confirmed cases of such transmission, donors and health care workers must be vigilant. “Given the frequency of travel of individuals within the United States, there is the risk that people without symptoms who are infected with Zika virus could potentially donate blood and thereby transmit Zika virus,” he said.

The CDC also published new numbers on Guillain-Barré syndrome (GBS), which has been on the rise in countries affected by Zika virus.

Individuals who began exhibiting any neurologic symptoms between Jan. 1, 2016, and July 31, 2016, and were suspected of possible GBS total 56. Of those 56 patients, 34 (61%) were found to have evidence of either Zika or another related flavivirus. Ten (18%) of those 56 were confirmed to have Zika virus, and 1 patient who received treatment for GBS died of septic shock. Thirty (88%) of the 34 found to have evidence of flavivirus also reported having an acute illness of some kind before the onset of neurologic symptoms. The figures come from the GBS Passive Surveillance System (MMWR. 2016 Aug 26. doi:10.15585/mmwr.mm6534e1).

“Persons with signs or symptoms consistent with GBS should promptly seek medical attention,” the CDC urged. “Health care providers who evaluate patients with neurologic illnesses should consider GBS and report suspected cases to public health authorities. Residents of and travelers to Puerto Rico are advised to follow existing recommendations for prevention of Zika virus infection.”

[email protected]

Officials at the Centers for Disease Control and Prevention have confirmed a case of Zika virus infection in a nonpregnant Maryland woman who likely contracted the virus through sexual intercourse with her asymptomatic male partner.

“To date, only one other case has been reported in which a man without symptoms might have sexually transmitted Zika virus to his female partner,” Richard B. Brooks, MD, and his colleagues wrote Aug. 26 in the Morbidity and Mortality Weekly Report (doi:10.15585/mmwr.mm6534e2). “However, in that reported case, both the man and the woman had traveled to a country with ongoing Zika virus transmission where they were likely exposed to mosquitoes.”

In the current case, the couple had condomless vaginal sex 10 days and 14 days after his return from the Dominican Republic, along with oral sex on day 14. Two days after the last encounter, the woman began exhibiting symptoms of Zika virus infection, namely, a maculopapular rash and a fever. She sought medical care 3 days later (19 days after her partner returned to the United States). She had no other sexual partners during this time. Meanwhile, the male sex partner reported no symptoms of a Zika virus infection, other than simply being tired from his recent travel.

“The findings in this report indicate that it might be appropriate to consider persons who have condomless sex with partners returning from areas with ongoing Zika virus transmission as exposed to Zika virus, regardless of whether the returning traveler reports symptoms of Zika virus infection,” the researchers wrote.

©Tomasz Gierygowski/thinkstockphotos.com

Transmission of Zika virus through blood transfusions is also a growing concern, particularly if an asymptomatic individual donated blood.

On Aug. 26, the Food and Drug Administration announced recommendations to test all donated blood and blood components across the United States and its territories for the Zika virus, to mitigate the chances of transmitting the virus through transfusions. In February, the FDA first issued guidance recommending that only areas with active Zika virus transmission screen donated blood.

“As new scientific and epidemiological information regarding Zika virus has become available, it’s clear that additional precautionary measures are necessary,” Luciana Borio, MD, FDA’s acting chief scientist, said in a statement. “We are issuing revised guidance for immediate implementation in order to help maintain the safety of the U.S. blood supply.”

In a conference call with reporters, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said that while there have not yet been any confirmed cases of such transmission, donors and health care workers must be vigilant. “Given the frequency of travel of individuals within the United States, there is the risk that people without symptoms who are infected with Zika virus could potentially donate blood and thereby transmit Zika virus,” he said.

The CDC also published new numbers on Guillain-Barré syndrome (GBS), which has been on the rise in countries affected by Zika virus.

Individuals who began exhibiting any neurologic symptoms between Jan. 1, 2016, and July 31, 2016, and were suspected of possible GBS total 56. Of those 56 patients, 34 (61%) were found to have evidence of either Zika or another related flavivirus. Ten (18%) of those 56 were confirmed to have Zika virus, and 1 patient who received treatment for GBS died of septic shock. Thirty (88%) of the 34 found to have evidence of flavivirus also reported having an acute illness of some kind before the onset of neurologic symptoms. The figures come from the GBS Passive Surveillance System (MMWR. 2016 Aug 26. doi:10.15585/mmwr.mm6534e1).

“Persons with signs or symptoms consistent with GBS should promptly seek medical attention,” the CDC urged. “Health care providers who evaluate patients with neurologic illnesses should consider GBS and report suspected cases to public health authorities. Residents of and travelers to Puerto Rico are advised to follow existing recommendations for prevention of Zika virus infection.”

[email protected]

A 66-year-old woman presents as a new patient for a clinic visit. She has a history of Guillain-Barré syndrome 10 years ago. The last immunization she received was a tetanus-diphtheria 12 years ago.

What do you recommend for her to receive over the next year?

A. Pneumococcal 13/Pneumococcal 23/Tdap/influenza vaccines.

B. Pneumococcal 13/Pneumococcal 23/Tdap vaccines.

C. Influenza vaccine.

D. No vaccines.

Guillain-Barré syndrome (GBS) is a rare, acute, immune-mediated polyneuropathy that has an incidence of about 2 cases per 100,000 people each year.¹ Most cases of GBS follow an infectious event (usually an upper respiratory infection or gastrointestinal infection). In 1976, administration of the swine flu vaccine was associated with an up to eightfold increased risk of GBS.^2,3 Many patients who have had GBS have been advised not to – or are fearful to – receive influenza vaccine or any vaccine.

Is there good evidence for patients with a history of GBS to avoid influenza vaccines or vaccinations in general?

The initial concern over the increased risk of GBS following the large-scale influenza vaccination in 1976 has not been realized with subsequent influenza vaccines. In a study by Baxter and colleagues, GBS cases from Kaiser Permanente Northern California from 1995 to 2006 were reviewed.⁴ They looked at whether patients had received influenza vaccine in the 6 weeks prior to GBS, compared with vaccination within the prior 9 months.

The odds ratio for influenza vaccination in the 6 weeks prior to GBS was 1.1 (95% confidence interval, 0.4-3.1). The odds ratio for receiving tetanus diphtheria vaccine in the 6 weeks prior to GBS was 1.4 (95% CI, 0.3-4.5); pneumococcal 23 vaccine, 0.7 (95% CI, 0.1-2.9); and all vaccines combined, 1.3 (95% CI, 0.8-2.3).

Shahed Iqbal, MBBS, et al. looked at the relationship between influenza illness, pneumonia, influenza vaccination, and GBS.⁵ They found that although influenza vaccine coverage increased from 20% to 36% over the study period, there was not an increase in GBS hospitalizations over the same period. There was a significant correlation between hospitalizations for pneumonia and influenza and GBS hospitalizations in the same month.

In a simulation study, Steven Hawken, PhD, and his colleagues concluded that under typical conditions (influenza incidence greater than 5% and vaccine effectiveness greater than 60%), influenza vaccination reduced GBS risk.⁶

There are fewer data on vaccination in patients who have previously had GBS, but there is enough evidence to help guide us.

Roger Baxter, MD, and colleagues, using the database in reference 4, looked at outcome of patients with GBS who received vaccinations subsequent to recovery from GBS.⁷ A total of 279 patient with previous GBS received a total of 989 vaccinations, including 405 trivalent influenza vaccinations. None of the patients with GBS who received vaccinations had a recurrence of GBS.

Krista Kuitwaard, MD, et al. reported identical findings in a survey of patients with a history of GBS or chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).⁸ A total of 245 patients with GBS responded to the survey. A total of 106 GBS patients had received influenza vaccine following their GBS diagnosis (a total of 775 vaccinations in those patients). None of the patients with a history of GBS who received influenza vaccination had a recurrence of their GBS.

The current position of the GBS/CIDP Foundation on vaccination for patients with GBS is as follows: The GBS/CIDP Foundation recommends avoiding immunizations that a GBS patient had received within 6 weeks of developing their initial symptoms.⁹

I think the current evidence is enough to guide us in this issue. Vaccinations, including influenza vaccine, are likely safe for patients with a history of GBS. The recommendation of the GBS/CIDP foundation is reasonable – to avoid immunizations that appeared to have potentially triggered the initial GBS (ones that had been received within 6 weeks of onset of symptoms).

In the case presented above, I think that choice A – receiving all the recommended immunizations – would be appropriate.

References

1. Neuroepidemiology 2011; 36(2):123-33.

2. Am J Epidemiol. 1979 Aug;110(2):105-23.

3. Clin Infect Dis. 2014 Apr;58(8):1149-55.

4. Clin Infect Dis. 2013 Jul;57(2):197-204.

5. Vaccine. 2015 Apr 21;33(17):2045-9.

6. Emerg Infect Dis. 2015 Feb;21(2):224-31.

7. Clin Infect Dis. 2012 Mar;54(6):800-4.

8. J Peripher Nerv Syst. 2009 Dec;14(4):310-5.

9. GBS/CIDP Foundation International, Position on Flu Shots and Vaccinations.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

A 66-year-old woman presents as a new patient for a clinic visit. She has a history of Guillain-Barré syndrome 10 years ago. The last immunization she received was a tetanus-diphtheria 12 years ago.

What do you recommend for her to receive over the next year?

A. Pneumococcal 13/Pneumococcal 23/Tdap/influenza vaccines.

B. Pneumococcal 13/Pneumococcal 23/Tdap vaccines.

C. Influenza vaccine.

D. No vaccines.

Guillain-Barré syndrome (GBS) is a rare, acute, immune-mediated polyneuropathy that has an incidence of about 2 cases per 100,000 people each year.¹ Most cases of GBS follow an infectious event (usually an upper respiratory infection or gastrointestinal infection). In 1976, administration of the swine flu vaccine was associated with an up to eightfold increased risk of GBS.^2,3 Many patients who have had GBS have been advised not to – or are fearful to – receive influenza vaccine or any vaccine.

Is there good evidence for patients with a history of GBS to avoid influenza vaccines or vaccinations in general?

The initial concern over the increased risk of GBS following the large-scale influenza vaccination in 1976 has not been realized with subsequent influenza vaccines. In a study by Baxter and colleagues, GBS cases from Kaiser Permanente Northern California from 1995 to 2006 were reviewed.⁴ They looked at whether patients had received influenza vaccine in the 6 weeks prior to GBS, compared with vaccination within the prior 9 months.

The odds ratio for influenza vaccination in the 6 weeks prior to GBS was 1.1 (95% confidence interval, 0.4-3.1). The odds ratio for receiving tetanus diphtheria vaccine in the 6 weeks prior to GBS was 1.4 (95% CI, 0.3-4.5); pneumococcal 23 vaccine, 0.7 (95% CI, 0.1-2.9); and all vaccines combined, 1.3 (95% CI, 0.8-2.3).

Shahed Iqbal, MBBS, et al. looked at the relationship between influenza illness, pneumonia, influenza vaccination, and GBS.⁵ They found that although influenza vaccine coverage increased from 20% to 36% over the study period, there was not an increase in GBS hospitalizations over the same period. There was a significant correlation between hospitalizations for pneumonia and influenza and GBS hospitalizations in the same month.

In a simulation study, Steven Hawken, PhD, and his colleagues concluded that under typical conditions (influenza incidence greater than 5% and vaccine effectiveness greater than 60%), influenza vaccination reduced GBS risk.⁶

There are fewer data on vaccination in patients who have previously had GBS, but there is enough evidence to help guide us.

Roger Baxter, MD, and colleagues, using the database in reference 4, looked at outcome of patients with GBS who received vaccinations subsequent to recovery from GBS.⁷ A total of 279 patient with previous GBS received a total of 989 vaccinations, including 405 trivalent influenza vaccinations. None of the patients with GBS who received vaccinations had a recurrence of GBS.

Krista Kuitwaard, MD, et al. reported identical findings in a survey of patients with a history of GBS or chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).⁸ A total of 245 patients with GBS responded to the survey. A total of 106 GBS patients had received influenza vaccine following their GBS diagnosis (a total of 775 vaccinations in those patients). None of the patients with a history of GBS who received influenza vaccination had a recurrence of their GBS.

The current position of the GBS/CIDP Foundation on vaccination for patients with GBS is as follows: The GBS/CIDP Foundation recommends avoiding immunizations that a GBS patient had received within 6 weeks of developing their initial symptoms.⁹

I think the current evidence is enough to guide us in this issue. Vaccinations, including influenza vaccine, are likely safe for patients with a history of GBS. The recommendation of the GBS/CIDP foundation is reasonable – to avoid immunizations that appeared to have potentially triggered the initial GBS (ones that had been received within 6 weeks of onset of symptoms).

In the case presented above, I think that choice A – receiving all the recommended immunizations – would be appropriate.

References

1. Neuroepidemiology 2011; 36(2):123-33.

2. Am J Epidemiol. 1979 Aug;110(2):105-23.

3. Clin Infect Dis. 2014 Apr;58(8):1149-55.

4. Clin Infect Dis. 2013 Jul;57(2):197-204.

5. Vaccine. 2015 Apr 21;33(17):2045-9.

6. Emerg Infect Dis. 2015 Feb;21(2):224-31.

7. Clin Infect Dis. 2012 Mar;54(6):800-4.

8. J Peripher Nerv Syst. 2009 Dec;14(4):310-5.

9. GBS/CIDP Foundation International, Position on Flu Shots and Vaccinations.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

A 66-year-old woman presents as a new patient for a clinic visit. She has a history of Guillain-Barré syndrome 10 years ago. The last immunization she received was a tetanus-diphtheria 12 years ago.

What do you recommend for her to receive over the next year?

A. Pneumococcal 13/Pneumococcal 23/Tdap/influenza vaccines.

B. Pneumococcal 13/Pneumococcal 23/Tdap vaccines.

C. Influenza vaccine.

D. No vaccines.

Guillain-Barré syndrome (GBS) is a rare, acute, immune-mediated polyneuropathy that has an incidence of about 2 cases per 100,000 people each year.¹ Most cases of GBS follow an infectious event (usually an upper respiratory infection or gastrointestinal infection). In 1976, administration of the swine flu vaccine was associated with an up to eightfold increased risk of GBS.^2,3 Many patients who have had GBS have been advised not to – or are fearful to – receive influenza vaccine or any vaccine.

Is there good evidence for patients with a history of GBS to avoid influenza vaccines or vaccinations in general?

The initial concern over the increased risk of GBS following the large-scale influenza vaccination in 1976 has not been realized with subsequent influenza vaccines. In a study by Baxter and colleagues, GBS cases from Kaiser Permanente Northern California from 1995 to 2006 were reviewed.⁴ They looked at whether patients had received influenza vaccine in the 6 weeks prior to GBS, compared with vaccination within the prior 9 months.

The odds ratio for influenza vaccination in the 6 weeks prior to GBS was 1.1 (95% confidence interval, 0.4-3.1). The odds ratio for receiving tetanus diphtheria vaccine in the 6 weeks prior to GBS was 1.4 (95% CI, 0.3-4.5); pneumococcal 23 vaccine, 0.7 (95% CI, 0.1-2.9); and all vaccines combined, 1.3 (95% CI, 0.8-2.3).

Shahed Iqbal, MBBS, et al. looked at the relationship between influenza illness, pneumonia, influenza vaccination, and GBS.⁵ They found that although influenza vaccine coverage increased from 20% to 36% over the study period, there was not an increase in GBS hospitalizations over the same period. There was a significant correlation between hospitalizations for pneumonia and influenza and GBS hospitalizations in the same month.

In a simulation study, Steven Hawken, PhD, and his colleagues concluded that under typical conditions (influenza incidence greater than 5% and vaccine effectiveness greater than 60%), influenza vaccination reduced GBS risk.⁶

There are fewer data on vaccination in patients who have previously had GBS, but there is enough evidence to help guide us.

Roger Baxter, MD, and colleagues, using the database in reference 4, looked at outcome of patients with GBS who received vaccinations subsequent to recovery from GBS.⁷ A total of 279 patient with previous GBS received a total of 989 vaccinations, including 405 trivalent influenza vaccinations. None of the patients with GBS who received vaccinations had a recurrence of GBS.

Krista Kuitwaard, MD, et al. reported identical findings in a survey of patients with a history of GBS or chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).⁸ A total of 245 patients with GBS responded to the survey. A total of 106 GBS patients had received influenza vaccine following their GBS diagnosis (a total of 775 vaccinations in those patients). None of the patients with a history of GBS who received influenza vaccination had a recurrence of their GBS.

The current position of the GBS/CIDP Foundation on vaccination for patients with GBS is as follows: The GBS/CIDP Foundation recommends avoiding immunizations that a GBS patient had received within 6 weeks of developing their initial symptoms.⁹

I think the current evidence is enough to guide us in this issue. Vaccinations, including influenza vaccine, are likely safe for patients with a history of GBS. The recommendation of the GBS/CIDP foundation is reasonable – to avoid immunizations that appeared to have potentially triggered the initial GBS (ones that had been received within 6 weeks of onset of symptoms).

In the case presented above, I think that choice A – receiving all the recommended immunizations – would be appropriate.

References

1. Neuroepidemiology 2011; 36(2):123-33.

2. Am J Epidemiol. 1979 Aug;110(2):105-23.

3. Clin Infect Dis. 2014 Apr;58(8):1149-55.

4. Clin Infect Dis. 2013 Jul;57(2):197-204.

5. Vaccine. 2015 Apr 21;33(17):2045-9.

6. Emerg Infect Dis. 2015 Feb;21(2):224-31.

7. Clin Infect Dis. 2012 Mar;54(6):800-4.

8. J Peripher Nerv Syst. 2009 Dec;14(4):310-5.

9. GBS/CIDP Foundation International, Position on Flu Shots and Vaccinations.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

Thymectomy improved 3-year clinical outcomes and proved superior to medical therapy for mild to severe nonthymomatous myasthenia gravis, according to a report published online Aug. 11 in the New England Journal of Medicine.

Compared with standard prednisone therapy, thymectomy plus prednisone decreased the number and severity of symptoms, allowed the lowering of steroid doses, decreased the number and length of hospitalizations for disease exacerbations, reduced the need for immunosuppressive agents, and improved health-related quality of life in an international, randomized clinical trial, said Gil I. Wolfe, MD, of the department of neurology, State University of New York at Buffalo and his associates.

Until now, thymectomy was known to be beneficial in some cases of myasthenia gravis “but with widely varying rates of clinical improvement or remission.” And the success of immunotherapy has raised the question of whether an invasive surgery is necessary. Data from randomized, controlled studies have been sparse.

Moreover, thymectomy rarely causes adverse effects, but “the procedure can cost up to $80,000 and can be associated with operative complications that need to be weighed against benefits.” In comparison, medical therapy with glucocorticoids and other immunosuppressive agents is less invasive but is definitely associated with adverse events, including some that are life threatening, and negatively impacts quality of life, the investigators said.

To address the lack of randomized controlled trial data, they assessed 3-year outcomes in 126 patients treated at 67 medical centers in 18 countries during a 6-year period. The study participants were aged 18-65 years, had a disease duration of less than 5 years at enrollment (median duration, 1 year), and had class II (mild generalized disease) to class IV (severe generalized disease) myasthenia gravis. These patients were randomly assigned to undergo thymectomy and receive standard prednisone therapy (66 participants) or to receive standard prednisone alone (60 participants).

Thymectomy was performed using a median sternotomy “with the goal of an en bloc resection of all mediastinal tissue that could anatomically contain gross or microscopic thymus.”

At follow-up, time-weighted average scores on the Quantitative Myasthenia Gravis scale were significantly lower by 2.85 points, indicating improved clinical status, in the thymectomy group than in the control group. Time-weighted average prednisone dose also was significantly lower, at an average alternate-day dose of 44 mg in the thymectomy group and 60 mg in the control group, Dr. Wolfe and his associates said (N Engl J Med. 2016 Aug 11. doi: 10.1056/NEJMoa1602489).

On a measure of treatment-related complications, scores favored thymectomy with regard to the number of patients with symptoms, the total number of symptoms, and the distress level related to symptoms throughout the study period. Fewer patients in the thymectomy group required hospitalization for exacerbations of myasthenia gravis (9% vs. 37%), and the mean cumulative number of hospital days was lower with thymectomy (8.4 vs. 19.2).

In addition, scores on the Myasthenia Gravis Activities of Daily Living scale favored thymectomy (2.24 vs. 3.41). Fewer patients in the thymectomy group required azathioprine (17% vs. 0.48%). And the percentage of patients who reported having minimal manifestations of the disease at 3 years was significantly higher with thymectomy (67%) than with prednisone alone (47%).

This study was supported by the National Institute of Neurological Disorders and Stroke, the Muscular Dystrophy Association, and the Myasthenia Gravis Foundation of America and received no commercial support. Dr. Wolfe reported ties to Alexion Pharmaceuticals, Alpha Cancer Technologies, Argenx, Baxalta, CSL Behring, Grifols, and UCB, and his associates reported ties to numerous industry sources.

Thymectomy improved 3-year clinical outcomes and proved superior to medical therapy for mild to severe nonthymomatous myasthenia gravis, according to a report published online Aug. 11 in the New England Journal of Medicine.

Compared with standard prednisone therapy, thymectomy plus prednisone decreased the number and severity of symptoms, allowed the lowering of steroid doses, decreased the number and length of hospitalizations for disease exacerbations, reduced the need for immunosuppressive agents, and improved health-related quality of life in an international, randomized clinical trial, said Gil I. Wolfe, MD, of the department of neurology, State University of New York at Buffalo and his associates.

Until now, thymectomy was known to be beneficial in some cases of myasthenia gravis “but with widely varying rates of clinical improvement or remission.” And the success of immunotherapy has raised the question of whether an invasive surgery is necessary. Data from randomized, controlled studies have been sparse.

Moreover, thymectomy rarely causes adverse effects, but “the procedure can cost up to $80,000 and can be associated with operative complications that need to be weighed against benefits.” In comparison, medical therapy with glucocorticoids and other immunosuppressive agents is less invasive but is definitely associated with adverse events, including some that are life threatening, and negatively impacts quality of life, the investigators said.

To address the lack of randomized controlled trial data, they assessed 3-year outcomes in 126 patients treated at 67 medical centers in 18 countries during a 6-year period. The study participants were aged 18-65 years, had a disease duration of less than 5 years at enrollment (median duration, 1 year), and had class II (mild generalized disease) to class IV (severe generalized disease) myasthenia gravis. These patients were randomly assigned to undergo thymectomy and receive standard prednisone therapy (66 participants) or to receive standard prednisone alone (60 participants).

Thymectomy was performed using a median sternotomy “with the goal of an en bloc resection of all mediastinal tissue that could anatomically contain gross or microscopic thymus.”

At follow-up, time-weighted average scores on the Quantitative Myasthenia Gravis scale were significantly lower by 2.85 points, indicating improved clinical status, in the thymectomy group than in the control group. Time-weighted average prednisone dose also was significantly lower, at an average alternate-day dose of 44 mg in the thymectomy group and 60 mg in the control group, Dr. Wolfe and his associates said (N Engl J Med. 2016 Aug 11. doi: 10.1056/NEJMoa1602489).

On a measure of treatment-related complications, scores favored thymectomy with regard to the number of patients with symptoms, the total number of symptoms, and the distress level related to symptoms throughout the study period. Fewer patients in the thymectomy group required hospitalization for exacerbations of myasthenia gravis (9% vs. 37%), and the mean cumulative number of hospital days was lower with thymectomy (8.4 vs. 19.2).

In addition, scores on the Myasthenia Gravis Activities of Daily Living scale favored thymectomy (2.24 vs. 3.41). Fewer patients in the thymectomy group required azathioprine (17% vs. 0.48%). And the percentage of patients who reported having minimal manifestations of the disease at 3 years was significantly higher with thymectomy (67%) than with prednisone alone (47%).

This study was supported by the National Institute of Neurological Disorders and Stroke, the Muscular Dystrophy Association, and the Myasthenia Gravis Foundation of America and received no commercial support. Dr. Wolfe reported ties to Alexion Pharmaceuticals, Alpha Cancer Technologies, Argenx, Baxalta, CSL Behring, Grifols, and UCB, and his associates reported ties to numerous industry sources.

Thymectomy improved 3-year clinical outcomes and proved superior to medical therapy for mild to severe nonthymomatous myasthenia gravis, according to a report published online Aug. 11 in the New England Journal of Medicine.

Compared with standard prednisone therapy, thymectomy plus prednisone decreased the number and severity of symptoms, allowed the lowering of steroid doses, decreased the number and length of hospitalizations for disease exacerbations, reduced the need for immunosuppressive agents, and improved health-related quality of life in an international, randomized clinical trial, said Gil I. Wolfe, MD, of the department of neurology, State University of New York at Buffalo and his associates.

Until now, thymectomy was known to be beneficial in some cases of myasthenia gravis “but with widely varying rates of clinical improvement or remission.” And the success of immunotherapy has raised the question of whether an invasive surgery is necessary. Data from randomized, controlled studies have been sparse.

Moreover, thymectomy rarely causes adverse effects, but “the procedure can cost up to $80,000 and can be associated with operative complications that need to be weighed against benefits.” In comparison, medical therapy with glucocorticoids and other immunosuppressive agents is less invasive but is definitely associated with adverse events, including some that are life threatening, and negatively impacts quality of life, the investigators said.

To address the lack of randomized controlled trial data, they assessed 3-year outcomes in 126 patients treated at 67 medical centers in 18 countries during a 6-year period. The study participants were aged 18-65 years, had a disease duration of less than 5 years at enrollment (median duration, 1 year), and had class II (mild generalized disease) to class IV (severe generalized disease) myasthenia gravis. These patients were randomly assigned to undergo thymectomy and receive standard prednisone therapy (66 participants) or to receive standard prednisone alone (60 participants).

Thymectomy was performed using a median sternotomy “with the goal of an en bloc resection of all mediastinal tissue that could anatomically contain gross or microscopic thymus.”

At follow-up, time-weighted average scores on the Quantitative Myasthenia Gravis scale were significantly lower by 2.85 points, indicating improved clinical status, in the thymectomy group than in the control group. Time-weighted average prednisone dose also was significantly lower, at an average alternate-day dose of 44 mg in the thymectomy group and 60 mg in the control group, Dr. Wolfe and his associates said (N Engl J Med. 2016 Aug 11. doi: 10.1056/NEJMoa1602489).

On a measure of treatment-related complications, scores favored thymectomy with regard to the number of patients with symptoms, the total number of symptoms, and the distress level related to symptoms throughout the study period. Fewer patients in the thymectomy group required hospitalization for exacerbations of myasthenia gravis (9% vs. 37%), and the mean cumulative number of hospital days was lower with thymectomy (8.4 vs. 19.2).

In addition, scores on the Myasthenia Gravis Activities of Daily Living scale favored thymectomy (2.24 vs. 3.41). Fewer patients in the thymectomy group required azathioprine (17% vs. 0.48%). And the percentage of patients who reported having minimal manifestations of the disease at 3 years was significantly higher with thymectomy (67%) than with prednisone alone (47%).

This study was supported by the National Institute of Neurological Disorders and Stroke, the Muscular Dystrophy Association, and the Myasthenia Gravis Foundation of America and received no commercial support. Dr. Wolfe reported ties to Alexion Pharmaceuticals, Alpha Cancer Technologies, Argenx, Baxalta, CSL Behring, Grifols, and UCB, and his associates reported ties to numerous industry sources.

The Food and Drug Administration is currently accepting public comments on the agency’s proposed plans to implement a law that will restrict compounding of human drug products.

A statement issued by the FDA provides links to two draft guidances that describe how the agency “would implement provisions of federal law that restrict compounding human drug products that are essentially copies of commercially available or approved drug products.” One draft guidance and the legal restrictions referenced therein are relevant to physicians and pharmacists, as well as state-licensed pharmacies or federal facilities that compound drugs, according to the FDA. The other guidance applies to outsourcing facilities.

Although compounded drug products, such as a medication made without a dye for a patient allergic to that dye, or a medication made into liquid form for a patient who cannot swallow a pill, “may benefit certain patients whose medical needs cannot be met by a commercially available or an FDA-approved drug product,” the FDA statement said. “Taking compounded drug products that are essentially copies of a commercially available or approved drug needlessly exposes patients to drug products that FDA has not evaluated for safety, effectiveness, and quality. In addition, the compounded drugs may not have been produced according to appropriate quality standards. Such compounding would also undermine the new drug approval and over-the-counter drug monograph systems in the United States.”

The statement refers to serious adverse events, including infections and deaths that have resulted from “poor-quality” compounded drugs.

Written or electronic comments can be submitted until Oct. 11, and information on submitting comments is available at regulations.gov.

[email protected]

The Food and Drug Administration is currently accepting public comments on the agency’s proposed plans to implement a law that will restrict compounding of human drug products.

A statement issued by the FDA provides links to two draft guidances that describe how the agency “would implement provisions of federal law that restrict compounding human drug products that are essentially copies of commercially available or approved drug products.” One draft guidance and the legal restrictions referenced therein are relevant to physicians and pharmacists, as well as state-licensed pharmacies or federal facilities that compound drugs, according to the FDA. The other guidance applies to outsourcing facilities.

Although compounded drug products, such as a medication made without a dye for a patient allergic to that dye, or a medication made into liquid form for a patient who cannot swallow a pill, “may benefit certain patients whose medical needs cannot be met by a commercially available or an FDA-approved drug product,” the FDA statement said. “Taking compounded drug products that are essentially copies of a commercially available or approved drug needlessly exposes patients to drug products that FDA has not evaluated for safety, effectiveness, and quality. In addition, the compounded drugs may not have been produced according to appropriate quality standards. Such compounding would also undermine the new drug approval and over-the-counter drug monograph systems in the United States.”

The statement refers to serious adverse events, including infections and deaths that have resulted from “poor-quality” compounded drugs.

Written or electronic comments can be submitted until Oct. 11, and information on submitting comments is available at regulations.gov.

[email protected]

The Food and Drug Administration is currently accepting public comments on the agency’s proposed plans to implement a law that will restrict compounding of human drug products.

A statement issued by the FDA provides links to two draft guidances that describe how the agency “would implement provisions of federal law that restrict compounding human drug products that are essentially copies of commercially available or approved drug products.” One draft guidance and the legal restrictions referenced therein are relevant to physicians and pharmacists, as well as state-licensed pharmacies or federal facilities that compound drugs, according to the FDA. The other guidance applies to outsourcing facilities.

Although compounded drug products, such as a medication made without a dye for a patient allergic to that dye, or a medication made into liquid form for a patient who cannot swallow a pill, “may benefit certain patients whose medical needs cannot be met by a commercially available or an FDA-approved drug product,” the FDA statement said. “Taking compounded drug products that are essentially copies of a commercially available or approved drug needlessly exposes patients to drug products that FDA has not evaluated for safety, effectiveness, and quality. In addition, the compounded drugs may not have been produced according to appropriate quality standards. Such compounding would also undermine the new drug approval and over-the-counter drug monograph systems in the United States.”

The statement refers to serious adverse events, including infections and deaths that have resulted from “poor-quality” compounded drugs.

Written or electronic comments can be submitted until Oct. 11, and information on submitting comments is available at regulations.gov.

[email protected]

BERLIN—The International Parkinson and Movement Disorder Society (MDS) Task Force on Genetic Nomenclature in Movement Disorders has constructed an online database that provides a comprehensive overview of movement disorders phenotypes linked to causative gene mutations. The new MDS Genetic Mutation Database, MDSGene, was introduced at the 20th International Congress of Parkinson’s Disease and Movement Disorders.

Christine Klein, MD

Led by Christine Klein, MD, at the University of Lübeck and Connie Marras, MD, PhD, at the University of Toronto, the MDS Task Force is comprised of a global team of experienced movement disorder specialists and geneticists. Christina Lill, MD, MS, in conjunction with Lars Bertram, MD, both at the University of Lübeck in Germany, spearheaded the development of this innovative tool, which uses genetic and phenotypic/clinical data extracted from relevant literature. MDSGene displays extensive data on mutations in Parkinson’s disease, paroxysmal movement disorders, and familial brain calcification. The database also provides a comprehensive list of the available literature and an extensive summary of patients’ characteristics for each gene of interest using graphic and tabular data summaries. Primarily, MDSGene can be used as a resource to assist clinical diagnosis and guide research in the field of hereditary movement disorders.

Connie Marras, MD, PhD

José A. Obeso, MD, PhD, Professor of Neurology at the University of Navarra, Pamplona, Spain, and Editor-in-Chief of Movement Disorders, stated, “This new database is based on a formal analysis of the different clinical presentation of movement disorders and the associated genetic mutations published in the May issue of Movement Disorders. This very valuable effort will eventually lead to a comprehensive account of most types of movement disorders and their genetic origin, thus allowing and facilitating many newer studies and also serving as a diagnostic tool to clinicians worldwide.” Dr. Obeso added, “In sum, MDSGene is a major contribution to a better definition, classification, and understanding of Parkinson’s disease and several other movement disorders.”

The MDSGene database is available at www.mdsgene.org.

BERLIN—The International Parkinson and Movement Disorder Society (MDS) Task Force on Genetic Nomenclature in Movement Disorders has constructed an online database that provides a comprehensive overview of movement disorders phenotypes linked to causative gene mutations. The new MDS Genetic Mutation Database, MDSGene, was introduced at the 20th International Congress of Parkinson’s Disease and Movement Disorders.

Christine Klein, MD

Led by Christine Klein, MD, at the University of Lübeck and Connie Marras, MD, PhD, at the University of Toronto, the MDS Task Force is comprised of a global team of experienced movement disorder specialists and geneticists. Christina Lill, MD, MS, in conjunction with Lars Bertram, MD, both at the University of Lübeck in Germany, spearheaded the development of this innovative tool, which uses genetic and phenotypic/clinical data extracted from relevant literature. MDSGene displays extensive data on mutations in Parkinson’s disease, paroxysmal movement disorders, and familial brain calcification. The database also provides a comprehensive list of the available literature and an extensive summary of patients’ characteristics for each gene of interest using graphic and tabular data summaries. Primarily, MDSGene can be used as a resource to assist clinical diagnosis and guide research in the field of hereditary movement disorders.

Connie Marras, MD, PhD

José A. Obeso, MD, PhD, Professor of Neurology at the University of Navarra, Pamplona, Spain, and Editor-in-Chief of Movement Disorders, stated, “This new database is based on a formal analysis of the different clinical presentation of movement disorders and the associated genetic mutations published in the May issue of Movement Disorders. This very valuable effort will eventually lead to a comprehensive account of most types of movement disorders and their genetic origin, thus allowing and facilitating many newer studies and also serving as a diagnostic tool to clinicians worldwide.” Dr. Obeso added, “In sum, MDSGene is a major contribution to a better definition, classification, and understanding of Parkinson’s disease and several other movement disorders.”

The MDSGene database is available at www.mdsgene.org.

BERLIN—The International Parkinson and Movement Disorder Society (MDS) Task Force on Genetic Nomenclature in Movement Disorders has constructed an online database that provides a comprehensive overview of movement disorders phenotypes linked to causative gene mutations. The new MDS Genetic Mutation Database, MDSGene, was introduced at the 20th International Congress of Parkinson’s Disease and Movement Disorders.

Christine Klein, MD

Led by Christine Klein, MD, at the University of Lübeck and Connie Marras, MD, PhD, at the University of Toronto, the MDS Task Force is comprised of a global team of experienced movement disorder specialists and geneticists. Christina Lill, MD, MS, in conjunction with Lars Bertram, MD, both at the University of Lübeck in Germany, spearheaded the development of this innovative tool, which uses genetic and phenotypic/clinical data extracted from relevant literature. MDSGene displays extensive data on mutations in Parkinson’s disease, paroxysmal movement disorders, and familial brain calcification. The database also provides a comprehensive list of the available literature and an extensive summary of patients’ characteristics for each gene of interest using graphic and tabular data summaries. Primarily, MDSGene can be used as a resource to assist clinical diagnosis and guide research in the field of hereditary movement disorders.

Connie Marras, MD, PhD

José A. Obeso, MD, PhD, Professor of Neurology at the University of Navarra, Pamplona, Spain, and Editor-in-Chief of Movement Disorders, stated, “This new database is based on a formal analysis of the different clinical presentation of movement disorders and the associated genetic mutations published in the May issue of Movement Disorders. This very valuable effort will eventually lead to a comprehensive account of most types of movement disorders and their genetic origin, thus allowing and facilitating many newer studies and also serving as a diagnostic tool to clinicians worldwide.” Dr. Obeso added, “In sum, MDSGene is a major contribution to a better definition, classification, and understanding of Parkinson’s disease and several other movement disorders.”

The MDSGene database is available at www.mdsgene.org.

VANCOUVER – The antioxidant edaravone was associated with less deterioration in functional rating and quality of life scales when started early in the course of amyotrophic lateral sclerosis (ALS), based on results from a set of trials conducted in Japan and reported at the annual meeting of the American Academy of Neurology.

Edaravone is thought to confer neuroprotection in part through its free radical–scavenging activity and first garnered interest for the treatment of acute ischemic stroke, according to presenting author Dr. Joseph M. Palumbo, vice president and head of Clinical Research at Mitsubishi Tanabe Pharma Development America, the maker of edaravone. It is now approved in several countries for that indication.

Susan London/Frontline Medical News

In a pivotal randomized phase III trial, Dr. Palumbo and his colleagues studied 137 patients who had definite or probable ALS, were less than 2 years out from symptom onset, had normal respiratory function, and were able to perform most activities of daily living. All patients received standard of care, usually including riluzole (Rilutek), plus either edaravone (MCI-186) or placebo.

After 24 weeks of treatment, compared with placebo, edaravone was associated with a smaller decline in scores on the Amyotrophic Lateral Sclerosis Functional Rating Scale–Revised (ALSFRS-R) (–5.01 vs. –7.50; difference between groups, 2.49; P = .0013), according to data reported in a poster session at the meeting.

Significant benefit was seen on the limb and bulbar subscales, and there was a trend favoring edaravone on the respiratory subscale. Additionally, patients given edaravone had comparatively less deterioration in quality of life as assessed with the 40-item Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) (P = .03). Grip strength did not differ between groups, and there were no deaths in either group.

“We are not aware of any other positive phase III study in maybe a generation, since riluzole, in ALS. So we are showing this data and we are hopeful that people are as excited as we are,” Dr. Palumbo said in an interview.

In the area of safety, edaravone and placebo did not differ significantly with respect to the rate of adverse events, with contusion, dysphagia, and constipation predominating. The most common serious adverse event was dysphagia, seen in 12% of each group.

The trial’s findings led to approval of edaravone for treatment of ALS in Japan, where it is marketed as Radicut. Additionally, the U.S. Food and Drug Administration (FDA) granted edaravone orphan drug designation for ALS but has not approved it for this indication.

An additional 24-week open-label extension study among 123 patients from the trial, in which all received the drug regardless of their initially assigned treatment, showed that the benefit of edaravone was durable. Patients who continued treatment with the drug had less of a decline from baseline in ALSFRS-R score than did peers switched to the drug from placebo (difference between groups, 4.17; P = .004), according to data reported in another poster. Also, the former had a lower risk of death (P = .019) and less decline in lung function. Meanwhile, the drug’s safety profile remained good.

The researchers are preparing their findings for journal submission and are revisiting the drug’s regulatory status in the United States, according to Dr. Palumbo. “We’re talking to the FDA now. We’ve got our fingers crossed.”

There is no compelling reason to think that the drug’s efficacy in the U.S. population would differ from that in the Japanese population, but that will ultimately be an issue for regulators to decide, he said.

It is difficult to compare edaravone with other ALS treatment options, as all patients in the trial concomitantly received standard of care, Dr. Palumbo explained. “We can only speak about standard of care, and we think that we’ve improved on standard of care here,” he maintained.

The initial phase III trial of edaravone in ALS, which enrolled a population having a wider range of disease severity, failed to meet its primary endpoint of improvement in ALSFRS-R score (Amyotroph Lateral Scler Frontotemporal Degener. 2014;15:610-7). An extension study in 181 patients, also reported in a poster at the meeting, supported post hoc findings hinting that the timing of drug initiation was important.

“We learned a tremendous amount in that study about who the patients were who would ultimately benefit,” Dr. Palumbo commented. “We had a number of hypotheses. One hypothesis was that if we found patients who in fact were still functional at baseline and who really had the diagnosis – they had either definite or probable ALS – and still had very good respiratory function, that we would likely find a signal there.”

Rounding out the set of trials was a small randomized placebo-controlled trial among 25 patients with more advanced ALS, done at the request of Japanese health authorities. Results showed that edaravone was safe in this population but had no clear benefit.

Dr. Palumbo disclosed that he is an employee of Mitsubishi Tanabe Pharma Development America, Inc. The trials were sponsored by Mitsubishi Tanabe Pharma Corporation.

VANCOUVER – The antioxidant edaravone was associated with less deterioration in functional rating and quality of life scales when started early in the course of amyotrophic lateral sclerosis (ALS), based on results from a set of trials conducted in Japan and reported at the annual meeting of the American Academy of Neurology.

Edaravone is thought to confer neuroprotection in part through its free radical–scavenging activity and first garnered interest for the treatment of acute ischemic stroke, according to presenting author Dr. Joseph M. Palumbo, vice president and head of Clinical Research at Mitsubishi Tanabe Pharma Development America, the maker of edaravone. It is now approved in several countries for that indication.

Susan London/Frontline Medical News

In a pivotal randomized phase III trial, Dr. Palumbo and his colleagues studied 137 patients who had definite or probable ALS, were less than 2 years out from symptom onset, had normal respiratory function, and were able to perform most activities of daily living. All patients received standard of care, usually including riluzole (Rilutek), plus either edaravone (MCI-186) or placebo.

After 24 weeks of treatment, compared with placebo, edaravone was associated with a smaller decline in scores on the Amyotrophic Lateral Sclerosis Functional Rating Scale–Revised (ALSFRS-R) (–5.01 vs. –7.50; difference between groups, 2.49; P = .0013), according to data reported in a poster session at the meeting.

Significant benefit was seen on the limb and bulbar subscales, and there was a trend favoring edaravone on the respiratory subscale. Additionally, patients given edaravone had comparatively less deterioration in quality of life as assessed with the 40-item Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) (P = .03). Grip strength did not differ between groups, and there were no deaths in either group.

“We are not aware of any other positive phase III study in maybe a generation, since riluzole, in ALS. So we are showing this data and we are hopeful that people are as excited as we are,” Dr. Palumbo said in an interview.

In the area of safety, edaravone and placebo did not differ significantly with respect to the rate of adverse events, with contusion, dysphagia, and constipation predominating. The most common serious adverse event was dysphagia, seen in 12% of each group.

The trial’s findings led to approval of edaravone for treatment of ALS in Japan, where it is marketed as Radicut. Additionally, the U.S. Food and Drug Administration (FDA) granted edaravone orphan drug designation for ALS but has not approved it for this indication.

An additional 24-week open-label extension study among 123 patients from the trial, in which all received the drug regardless of their initially assigned treatment, showed that the benefit of edaravone was durable. Patients who continued treatment with the drug had less of a decline from baseline in ALSFRS-R score than did peers switched to the drug from placebo (difference between groups, 4.17; P = .004), according to data reported in another poster. Also, the former had a lower risk of death (P = .019) and less decline in lung function. Meanwhile, the drug’s safety profile remained good.

The researchers are preparing their findings for journal submission and are revisiting the drug’s regulatory status in the United States, according to Dr. Palumbo. “We’re talking to the FDA now. We’ve got our fingers crossed.”

There is no compelling reason to think that the drug’s efficacy in the U.S. population would differ from that in the Japanese population, but that will ultimately be an issue for regulators to decide, he said.

It is difficult to compare edaravone with other ALS treatment options, as all patients in the trial concomitantly received standard of care, Dr. Palumbo explained. “We can only speak about standard of care, and we think that we’ve improved on standard of care here,” he maintained.

The initial phase III trial of edaravone in ALS, which enrolled a population having a wider range of disease severity, failed to meet its primary endpoint of improvement in ALSFRS-R score (Amyotroph Lateral Scler Frontotemporal Degener. 2014;15:610-7). An extension study in 181 patients, also reported in a poster at the meeting, supported post hoc findings hinting that the timing of drug initiation was important.

“We learned a tremendous amount in that study about who the patients were who would ultimately benefit,” Dr. Palumbo commented. “We had a number of hypotheses. One hypothesis was that if we found patients who in fact were still functional at baseline and who really had the diagnosis – they had either definite or probable ALS – and still had very good respiratory function, that we would likely find a signal there.”

Rounding out the set of trials was a small randomized placebo-controlled trial among 25 patients with more advanced ALS, done at the request of Japanese health authorities. Results showed that edaravone was safe in this population but had no clear benefit.

Dr. Palumbo disclosed that he is an employee of Mitsubishi Tanabe Pharma Development America, Inc. The trials were sponsored by Mitsubishi Tanabe Pharma Corporation.

VANCOUVER – The antioxidant edaravone was associated with less deterioration in functional rating and quality of life scales when started early in the course of amyotrophic lateral sclerosis (ALS), based on results from a set of trials conducted in Japan and reported at the annual meeting of the American Academy of Neurology.

Edaravone is thought to confer neuroprotection in part through its free radical–scavenging activity and first garnered interest for the treatment of acute ischemic stroke, according to presenting author Dr. Joseph M. Palumbo, vice president and head of Clinical Research at Mitsubishi Tanabe Pharma Development America, the maker of edaravone. It is now approved in several countries for that indication.

Susan London/Frontline Medical News

In a pivotal randomized phase III trial, Dr. Palumbo and his colleagues studied 137 patients who had definite or probable ALS, were less than 2 years out from symptom onset, had normal respiratory function, and were able to perform most activities of daily living. All patients received standard of care, usually including riluzole (Rilutek), plus either edaravone (MCI-186) or placebo.

After 24 weeks of treatment, compared with placebo, edaravone was associated with a smaller decline in scores on the Amyotrophic Lateral Sclerosis Functional Rating Scale–Revised (ALSFRS-R) (–5.01 vs. –7.50; difference between groups, 2.49; P = .0013), according to data reported in a poster session at the meeting.

Significant benefit was seen on the limb and bulbar subscales, and there was a trend favoring edaravone on the respiratory subscale. Additionally, patients given edaravone had comparatively less deterioration in quality of life as assessed with the 40-item Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) (P = .03). Grip strength did not differ between groups, and there were no deaths in either group.

“We are not aware of any other positive phase III study in maybe a generation, since riluzole, in ALS. So we are showing this data and we are hopeful that people are as excited as we are,” Dr. Palumbo said in an interview.

In the area of safety, edaravone and placebo did not differ significantly with respect to the rate of adverse events, with contusion, dysphagia, and constipation predominating. The most common serious adverse event was dysphagia, seen in 12% of each group.

The trial’s findings led to approval of edaravone for treatment of ALS in Japan, where it is marketed as Radicut. Additionally, the U.S. Food and Drug Administration (FDA) granted edaravone orphan drug designation for ALS but has not approved it for this indication.

An additional 24-week open-label extension study among 123 patients from the trial, in which all received the drug regardless of their initially assigned treatment, showed that the benefit of edaravone was durable. Patients who continued treatment with the drug had less of a decline from baseline in ALSFRS-R score than did peers switched to the drug from placebo (difference between groups, 4.17; P = .004), according to data reported in another poster. Also, the former had a lower risk of death (P = .019) and less decline in lung function. Meanwhile, the drug’s safety profile remained good.

The researchers are preparing their findings for journal submission and are revisiting the drug’s regulatory status in the United States, according to Dr. Palumbo. “We’re talking to the FDA now. We’ve got our fingers crossed.”

There is no compelling reason to think that the drug’s efficacy in the U.S. population would differ from that in the Japanese population, but that will ultimately be an issue for regulators to decide, he said.

It is difficult to compare edaravone with other ALS treatment options, as all patients in the trial concomitantly received standard of care, Dr. Palumbo explained. “We can only speak about standard of care, and we think that we’ve improved on standard of care here,” he maintained.

The initial phase III trial of edaravone in ALS, which enrolled a population having a wider range of disease severity, failed to meet its primary endpoint of improvement in ALSFRS-R score (Amyotroph Lateral Scler Frontotemporal Degener. 2014;15:610-7). An extension study in 181 patients, also reported in a poster at the meeting, supported post hoc findings hinting that the timing of drug initiation was important.

“We learned a tremendous amount in that study about who the patients were who would ultimately benefit,” Dr. Palumbo commented. “We had a number of hypotheses. One hypothesis was that if we found patients who in fact were still functional at baseline and who really had the diagnosis – they had either definite or probable ALS – and still had very good respiratory function, that we would likely find a signal there.”

Rounding out the set of trials was a small randomized placebo-controlled trial among 25 patients with more advanced ALS, done at the request of Japanese health authorities. Results showed that edaravone was safe in this population but had no clear benefit.

Dr. Palumbo disclosed that he is an employee of Mitsubishi Tanabe Pharma Development America, Inc. The trials were sponsored by Mitsubishi Tanabe Pharma Corporation.

The ability of the United States to respond to a potential spike in Zika virus infection rates is a cause for concern, according to a top federal health official.

“The big question is will we get local transmission, and my response to that is very likely we will,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told reporters during a joint media briefing with the Pan American Health Organization (PAHO) on May 3.

As many as 500 million people in the Americas are at risk for being infected by the Zika virus, PAHO’s Zika incident manager, Dr. Sylvain Aldighieri, said during the briefing.

In the continental United States to date, there have been about 400 travel-related cases of infection. In Puerto Rico, there have been nearly 700 locally reported cases, and one Zika-related death.

Countries at highest risk for Zika include those that have experienced any outbreaks of dengue fever or chikungunya in the past 15 years, Dr. Aldighieri said. Hawaii and U.S. territories in the Caribbean have experienced local dengue outbreaks during that time. Florida has had local outbreaks of both illnesses.

In the United States, Zika is poised to gain a stronger foothold even as funding for the study and prevention of the virus remains stalled in Congress, and a lack of cohesive public health messaging leaves the public vulnerable to misunderstanding the potential threat of the disease, according to Dr. Fauci.

A vaccine to fight Zika virus is currently under development. “Don’t confuse that with readiness,” Dr. Fauci cautioned.

Dr. Fauci said he believes the disbursement by Congress of President Obama’s requested $1.9 billion in Zika-related funds would facilitate a more comprehensive approach to preventing and treating the virus’s spread, but so far, the funding remains stalled.

As a result, Dr. Fauci said he has reallocated funds intended for other infectious disease research needs to cover Zika-related costs, but is concerned that continued congressional inaction could mean he is left with holes across many budgets. “That 1.9 billion dollars is essential,” he said.

Vaccine progress

In April, $589 millionin funds primarily earmarked for the Ebola crisis were redirected by the Obama administration to fight the Zika virus. That money is now being used in part to fund development of a vaccine that is expected to be ready for a phase I study of 80 people by September 2016. If successful, a phase II-b efficacy study of the vaccine would be conducted in the first quarter of 2017 in a country or region that has a high rate of infection.

Dr. Fauci said that although the study is not be as high-powered as would be ideal, researchers might be able to determine the vaccine’s efficacy with several thousand volunteers, taking into consideration that during the 1-3 years needed to gather conclusive data, herd immunity could skew rates of infection downward, bringing into question the vaccine’s actual efficacy.

“That’s just something we have to deal with,” Dr. Fauci said, saying that fewer people being infected is a good thing, either way.

Research gaps

Other pressing Zika research needs to include learning more about the virus’s impact on a developing fetus.

“We don’t know exactly what the percentage is of [infants born with] microcephaly,” Dr. Fauci said. “We don’t know beyond microcephaly what the long-range effects are on babies that look like they were born [without microcephaly] but might have other defects that are more subtle.”

Dr. Fauci said current data are unhelpful in that they show anywhere from 1% to 29% of infected mothers will give birth to children with congenital defects. However, he said that a coalition of nations affected by the virus is currently enrolling thousands of pregnant women in a cohort study to determine risk ratios.

“When we get the data from that study, we will be able to answer precisely what the percentage is, but today in May 2016, we don’t know the answer,” he said.

Predicting which infants are most susceptible, and at what point in utero abnormalities develop, are questions still under investigation, although a study published earlier this year supports the theory that infection during the first trimester poses the highest risk to a developing fetus.

Communicating risk

Another problem facing health officials is how to communicate the potential seriousness of an illness that, if it presents at all, does so only mildly, Dr. Fauci said. “In general, it’s a disease in which 80% of people don’t have any symptoms.”

The World Health Organization advises physicians to suspect Zika – particularly if a person has been in Zika-affected regions – if clinical symptoms include rash, fever, or both, plus at least one of these: arthralgia, arthritis, or conjunctivitis. Aside from bed rest, hydration, and over-the-counter analgesics, there are no specific treatments for the virus.

How to counsel women about avoiding pregnancy where Zika is a concern also poses challenges, particularly if the pregnancy is unintended, as about half of all American pregnancies are, or if, as Dr. Fauci told reporters, pregnancy is “guided by laws and religion.”

Although federal policy has not been to advise persons about whether to delay pregnancy, Dr. Fauci said U.S. officials are unwilling to contradict authorities in local regions such as Puerto Rico where such statements have been issued.

On April 28, the Food and Drug Administration authorized the emergency use of a commercial in vitro diagnostic test for use in individuals with symptoms of the virus, or those who have traveled to affected regions. Earlier this year, the FDA granted emergency authorization for use of a single test that can detect Zika, dengue, and chikungunya. Still, serology tests for Zika are often inconclusive, since the virus can mimic dengue or chikungunya, according to Dr. Aldighieri. “It can be complex to know if there is a Zika or dengue or chikungunya outbreak,” he said.

[email protected]

On Twitter @whitneymcknight

The ability of the United States to respond to a potential spike in Zika virus infection rates is a cause for concern, according to a top federal health official.

“The big question is will we get local transmission, and my response to that is very likely we will,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told reporters during a joint media briefing with the Pan American Health Organization (PAHO) on May 3.

As many as 500 million people in the Americas are at risk for being infected by the Zika virus, PAHO’s Zika incident manager, Dr. Sylvain Aldighieri, said during the briefing.

In the continental United States to date, there have been about 400 travel-related cases of infection. In Puerto Rico, there have been nearly 700 locally reported cases, and one Zika-related death.

Countries at highest risk for Zika include those that have experienced any outbreaks of dengue fever or chikungunya in the past 15 years, Dr. Aldighieri said. Hawaii and U.S. territories in the Caribbean have experienced local dengue outbreaks during that time. Florida has had local outbreaks of both illnesses.

In the United States, Zika is poised to gain a stronger foothold even as funding for the study and prevention of the virus remains stalled in Congress, and a lack of cohesive public health messaging leaves the public vulnerable to misunderstanding the potential threat of the disease, according to Dr. Fauci.

A vaccine to fight Zika virus is currently under development. “Don’t confuse that with readiness,” Dr. Fauci cautioned.

Dr. Fauci said he believes the disbursement by Congress of President Obama’s requested $1.9 billion in Zika-related funds would facilitate a more comprehensive approach to preventing and treating the virus’s spread, but so far, the funding remains stalled.

As a result, Dr. Fauci said he has reallocated funds intended for other infectious disease research needs to cover Zika-related costs, but is concerned that continued congressional inaction could mean he is left with holes across many budgets. “That 1.9 billion dollars is essential,” he said.

Vaccine progress

In April, $589 millionin funds primarily earmarked for the Ebola crisis were redirected by the Obama administration to fight the Zika virus. That money is now being used in part to fund development of a vaccine that is expected to be ready for a phase I study of 80 people by September 2016. If successful, a phase II-b efficacy study of the vaccine would be conducted in the first quarter of 2017 in a country or region that has a high rate of infection.

Dr. Fauci said that although the study is not be as high-powered as would be ideal, researchers might be able to determine the vaccine’s efficacy with several thousand volunteers, taking into consideration that during the 1-3 years needed to gather conclusive data, herd immunity could skew rates of infection downward, bringing into question the vaccine’s actual efficacy.

“That’s just something we have to deal with,” Dr. Fauci said, saying that fewer people being infected is a good thing, either way.

Research gaps

Other pressing Zika research needs to include learning more about the virus’s impact on a developing fetus.

“We don’t know exactly what the percentage is of [infants born with] microcephaly,” Dr. Fauci said. “We don’t know beyond microcephaly what the long-range effects are on babies that look like they were born [without microcephaly] but might have other defects that are more subtle.”

Dr. Fauci said current data are unhelpful in that they show anywhere from 1% to 29% of infected mothers will give birth to children with congenital defects. However, he said that a coalition of nations affected by the virus is currently enrolling thousands of pregnant women in a cohort study to determine risk ratios.

“When we get the data from that study, we will be able to answer precisely what the percentage is, but today in May 2016, we don’t know the answer,” he said.

Predicting which infants are most susceptible, and at what point in utero abnormalities develop, are questions still under investigation, although a study published earlier this year supports the theory that infection during the first trimester poses the highest risk to a developing fetus.

Communicating risk

Another problem facing health officials is how to communicate the potential seriousness of an illness that, if it presents at all, does so only mildly, Dr. Fauci said. “In general, it’s a disease in which 80% of people don’t have any symptoms.”

The World Health Organization advises physicians to suspect Zika – particularly if a person has been in Zika-affected regions – if clinical symptoms include rash, fever, or both, plus at least one of these: arthralgia, arthritis, or conjunctivitis. Aside from bed rest, hydration, and over-the-counter analgesics, there are no specific treatments for the virus.

How to counsel women about avoiding pregnancy where Zika is a concern also poses challenges, particularly if the pregnancy is unintended, as about half of all American pregnancies are, or if, as Dr. Fauci told reporters, pregnancy is “guided by laws and religion.”

Although federal policy has not been to advise persons about whether to delay pregnancy, Dr. Fauci said U.S. officials are unwilling to contradict authorities in local regions such as Puerto Rico where such statements have been issued.

On April 28, the Food and Drug Administration authorized the emergency use of a commercial in vitro diagnostic test for use in individuals with symptoms of the virus, or those who have traveled to affected regions. Earlier this year, the FDA granted emergency authorization for use of a single test that can detect Zika, dengue, and chikungunya. Still, serology tests for Zika are often inconclusive, since the virus can mimic dengue or chikungunya, according to Dr. Aldighieri. “It can be complex to know if there is a Zika or dengue or chikungunya outbreak,” he said.

[email protected]

On Twitter @whitneymcknight

The ability of the United States to respond to a potential spike in Zika virus infection rates is a cause for concern, according to a top federal health official.

“The big question is will we get local transmission, and my response to that is very likely we will,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told reporters during a joint media briefing with the Pan American Health Organization (PAHO) on May 3.

As many as 500 million people in the Americas are at risk for being infected by the Zika virus, PAHO’s Zika incident manager, Dr. Sylvain Aldighieri, said during the briefing.

In the continental United States to date, there have been about 400 travel-related cases of infection. In Puerto Rico, there have been nearly 700 locally reported cases, and one Zika-related death.

Countries at highest risk for Zika include those that have experienced any outbreaks of dengue fever or chikungunya in the past 15 years, Dr. Aldighieri said. Hawaii and U.S. territories in the Caribbean have experienced local dengue outbreaks during that time. Florida has had local outbreaks of both illnesses.

In the United States, Zika is poised to gain a stronger foothold even as funding for the study and prevention of the virus remains stalled in Congress, and a lack of cohesive public health messaging leaves the public vulnerable to misunderstanding the potential threat of the disease, according to Dr. Fauci.

A vaccine to fight Zika virus is currently under development. “Don’t confuse that with readiness,” Dr. Fauci cautioned.

Dr. Fauci said he believes the disbursement by Congress of President Obama’s requested $1.9 billion in Zika-related funds would facilitate a more comprehensive approach to preventing and treating the virus’s spread, but so far, the funding remains stalled.

As a result, Dr. Fauci said he has reallocated funds intended for other infectious disease research needs to cover Zika-related costs, but is concerned that continued congressional inaction could mean he is left with holes across many budgets. “That 1.9 billion dollars is essential,” he said.

Vaccine progress

In April, $589 millionin funds primarily earmarked for the Ebola crisis were redirected by the Obama administration to fight the Zika virus. That money is now being used in part to fund development of a vaccine that is expected to be ready for a phase I study of 80 people by September 2016. If successful, a phase II-b efficacy study of the vaccine would be conducted in the first quarter of 2017 in a country or region that has a high rate of infection.

Dr. Fauci said that although the study is not be as high-powered as would be ideal, researchers might be able to determine the vaccine’s efficacy with several thousand volunteers, taking into consideration that during the 1-3 years needed to gather conclusive data, herd immunity could skew rates of infection downward, bringing into question the vaccine’s actual efficacy.

“That’s just something we have to deal with,” Dr. Fauci said, saying that fewer people being infected is a good thing, either way.

Research gaps

Other pressing Zika research needs to include learning more about the virus’s impact on a developing fetus.

“We don’t know exactly what the percentage is of [infants born with] microcephaly,” Dr. Fauci said. “We don’t know beyond microcephaly what the long-range effects are on babies that look like they were born [without microcephaly] but might have other defects that are more subtle.”

Dr. Fauci said current data are unhelpful in that they show anywhere from 1% to 29% of infected mothers will give birth to children with congenital defects. However, he said that a coalition of nations affected by the virus is currently enrolling thousands of pregnant women in a cohort study to determine risk ratios.

“When we get the data from that study, we will be able to answer precisely what the percentage is, but today in May 2016, we don’t know the answer,” he said.

Predicting which infants are most susceptible, and at what point in utero abnormalities develop, are questions still under investigation, although a study published earlier this year supports the theory that infection during the first trimester poses the highest risk to a developing fetus.

Communicating risk

Another problem facing health officials is how to communicate the potential seriousness of an illness that, if it presents at all, does so only mildly, Dr. Fauci said. “In general, it’s a disease in which 80% of people don’t have any symptoms.”

The World Health Organization advises physicians to suspect Zika – particularly if a person has been in Zika-affected regions – if clinical symptoms include rash, fever, or both, plus at least one of these: arthralgia, arthritis, or conjunctivitis. Aside from bed rest, hydration, and over-the-counter analgesics, there are no specific treatments for the virus.

How to counsel women about avoiding pregnancy where Zika is a concern also poses challenges, particularly if the pregnancy is unintended, as about half of all American pregnancies are, or if, as Dr. Fauci told reporters, pregnancy is “guided by laws and religion.”

Although federal policy has not been to advise persons about whether to delay pregnancy, Dr. Fauci said U.S. officials are unwilling to contradict authorities in local regions such as Puerto Rico where such statements have been issued.

On April 28, the Food and Drug Administration authorized the emergency use of a commercial in vitro diagnostic test for use in individuals with symptoms of the virus, or those who have traveled to affected regions. Earlier this year, the FDA granted emergency authorization for use of a single test that can detect Zika, dengue, and chikungunya. Still, serology tests for Zika are often inconclusive, since the virus can mimic dengue or chikungunya, according to Dr. Aldighieri. “It can be complex to know if there is a Zika or dengue or chikungunya outbreak,” he said.

[email protected]

On Twitter @whitneymcknight

Since the beginning of the Zika virus outbreak in November 2015, Puerto Rico has had 683 cases of virus that have been laboratory-confirmed or presumed positive, according to new data from the Centers for Disease Control and Prevention.

Of the 683 Zika virus cases, 64% were found in women, with 65 cases occurring in pregnant women. The median age of patients was 34 years old. The most common symptoms were rash, myalgia, headache, fever, and arthralgia, all seen in more than 60% of patients. Hospitalization was required for 17 patients, and 1 death occurred due to complications from a severe thrombocytopenia. The data covers the time period of Nov. 1, 2015 to April 14, 2016.

©Devonyu/Thinkstock

Cases of Zika virus were negligible until the final week of November 2015, and rose slowly until spiking dramatically at the beginning of February 2016. Since early February, incidence of Zika has not fallen below 40 cases a week. Between Nov. 1, 2015 and April 14, 2016, there have been 110 cases of dengue and 61 cases of chikungunya reported, and neither had an incidence greater than 25 cases a week.

“Although Zika virus–associated deaths are rare, the first identified death in Puerto Rico highlights the possibility of severe cases, as well as the need for continued outreach to raise health care providers’ awareness of complications that might lead to severe disease or death,” the CDC investigators wrote. “To ensure continued blood safety, blood collection resumed with a donor screening program for Zika virus infection, and all units screened positive are removed.”

Find the full report in the CDC’s Morbidity and Mortality Weekly Report (doi: 10.15585/mmwr.mm6517e2)

[email protected]

Since the beginning of the Zika virus outbreak in November 2015, Puerto Rico has had 683 cases of virus that have been laboratory-confirmed or presumed positive, according to new data from the Centers for Disease Control and Prevention.

Of the 683 Zika virus cases, 64% were found in women, with 65 cases occurring in pregnant women. The median age of patients was 34 years old. The most common symptoms were rash, myalgia, headache, fever, and arthralgia, all seen in more than 60% of patients. Hospitalization was required for 17 patients, and 1 death occurred due to complications from a severe thrombocytopenia. The data covers the time period of Nov. 1, 2015 to April 14, 2016.

©Devonyu/Thinkstock

Cases of Zika virus were negligible until the final week of November 2015, and rose slowly until spiking dramatically at the beginning of February 2016. Since early February, incidence of Zika has not fallen below 40 cases a week. Between Nov. 1, 2015 and April 14, 2016, there have been 110 cases of dengue and 61 cases of chikungunya reported, and neither had an incidence greater than 25 cases a week.

“Although Zika virus–associated deaths are rare, the first identified death in Puerto Rico highlights the possibility of severe cases, as well as the need for continued outreach to raise health care providers’ awareness of complications that might lead to severe disease or death,” the CDC investigators wrote. “To ensure continued blood safety, blood collection resumed with a donor screening program for Zika virus infection, and all units screened positive are removed.”

Find the full report in the CDC’s Morbidity and Mortality Weekly Report (doi: 10.15585/mmwr.mm6517e2)

[email protected]

Since the beginning of the Zika virus outbreak in November 2015, Puerto Rico has had 683 cases of virus that have been laboratory-confirmed or presumed positive, according to new data from the Centers for Disease Control and Prevention.

Of the 683 Zika virus cases, 64% were found in women, with 65 cases occurring in pregnant women. The median age of patients was 34 years old. The most common symptoms were rash, myalgia, headache, fever, and arthralgia, all seen in more than 60% of patients. Hospitalization was required for 17 patients, and 1 death occurred due to complications from a severe thrombocytopenia. The data covers the time period of Nov. 1, 2015 to April 14, 2016.

©Devonyu/Thinkstock

Cases of Zika virus were negligible until the final week of November 2015, and rose slowly until spiking dramatically at the beginning of February 2016. Since early February, incidence of Zika has not fallen below 40 cases a week. Between Nov. 1, 2015 and April 14, 2016, there have been 110 cases of dengue and 61 cases of chikungunya reported, and neither had an incidence greater than 25 cases a week.

“Although Zika virus–associated deaths are rare, the first identified death in Puerto Rico highlights the possibility of severe cases, as well as the need for continued outreach to raise health care providers’ awareness of complications that might lead to severe disease or death,” the CDC investigators wrote. “To ensure continued blood safety, blood collection resumed with a donor screening program for Zika virus infection, and all units screened positive are removed.”

Find the full report in the CDC’s Morbidity and Mortality Weekly Report (doi: 10.15585/mmwr.mm6517e2)

[email protected]