Christine Kilgore

Most states have not yet reached national targets set for dental health care in patients with diabetes, or have not made significant improvements in the past 5 years—a finding that “underscore(s) the need to increase awareness and support for oral health care among adults with diabetes,” according to the Centers for Disease Control and Prevention.

Only seven states thus far have reached the national health objective for 2010 of increasing to at least 71% the proportion of people with diabetes who have annual dental examinations. And only four states and the District of Columbia made significant improvements between 1999 and 2004 (MMWR 2005:54:1181–3).

Adults with diabetes have both a higher prevalence of periodontal disease and more severe forms of the disease. And periodontal disease has been associated with development of glucose intolerance and poor glycemic control among adults with diabetes, the CDCsaid.

The CDC analyzed data from the state-based telephone surveys that were conducted in 1999 and 2004 as part of the Behavioral Risk Factor Surveillance System.

Participants in the telephone survey were asked how long it had been since they last visited a dentist or a dental clinic for any reason.

The participants who identified themselves as dentate and diabetic and who provided information about their dental visit history—approximately 21,000 respondents—were included in the data analysis.

Nationally, a median of 67% reported in the 2004 survey that they had a dental visit during the preceding 12 months—up just 1% from 66% in 1999.

Age-adjusted estimates for 2004 exceeded 71% in Kansas, Minnesota, Nebraska, Pennsylvania, Rhode Island, Utah, and Wisconsin. Significant increases over 1999 were seen in Arizona, the District of Columbia, Kansas, Minnesota, and Ohio.

The District of Columbia made the biggest strides, increasing its estimated percentage of dental patients to 71% in 2004 from just 37%—the lowest percentage in any state—in 1999.

Diabetes education programs should emphasize dental care for all people with the disease, “with emphasis on non-Hispanic blacks, persons with lower education and income, and those who lack health insurance,” the CDC stated. These groups were least likely to report dental visits.

Most states have not yet reached national targets set for dental health care in patients with diabetes, or have not made significant improvements in the past 5 years—a finding that “underscore(s) the need to increase awareness and support for oral health care among adults with diabetes,” according to the Centers for Disease Control and Prevention.

Only seven states thus far have reached the national health objective for 2010 of increasing to at least 71% the proportion of people with diabetes who have annual dental examinations. And only four states and the District of Columbia made significant improvements between 1999 and 2004 (MMWR 2005:54:1181–3).

Adults with diabetes have both a higher prevalence of periodontal disease and more severe forms of the disease. And periodontal disease has been associated with development of glucose intolerance and poor glycemic control among adults with diabetes, the CDCsaid.

The CDC analyzed data from the state-based telephone surveys that were conducted in 1999 and 2004 as part of the Behavioral Risk Factor Surveillance System.

Participants in the telephone survey were asked how long it had been since they last visited a dentist or a dental clinic for any reason.

The participants who identified themselves as dentate and diabetic and who provided information about their dental visit history—approximately 21,000 respondents—were included in the data analysis.

Nationally, a median of 67% reported in the 2004 survey that they had a dental visit during the preceding 12 months—up just 1% from 66% in 1999.

Age-adjusted estimates for 2004 exceeded 71% in Kansas, Minnesota, Nebraska, Pennsylvania, Rhode Island, Utah, and Wisconsin. Significant increases over 1999 were seen in Arizona, the District of Columbia, Kansas, Minnesota, and Ohio.

The District of Columbia made the biggest strides, increasing its estimated percentage of dental patients to 71% in 2004 from just 37%—the lowest percentage in any state—in 1999.

Diabetes education programs should emphasize dental care for all people with the disease, “with emphasis on non-Hispanic blacks, persons with lower education and income, and those who lack health insurance,” the CDC stated. These groups were least likely to report dental visits.

Most states have not yet reached national targets set for dental health care in patients with diabetes, or have not made significant improvements in the past 5 years—a finding that “underscore(s) the need to increase awareness and support for oral health care among adults with diabetes,” according to the Centers for Disease Control and Prevention.

Only seven states thus far have reached the national health objective for 2010 of increasing to at least 71% the proportion of people with diabetes who have annual dental examinations. And only four states and the District of Columbia made significant improvements between 1999 and 2004 (MMWR 2005:54:1181–3).

Adults with diabetes have both a higher prevalence of periodontal disease and more severe forms of the disease. And periodontal disease has been associated with development of glucose intolerance and poor glycemic control among adults with diabetes, the CDCsaid.

The CDC analyzed data from the state-based telephone surveys that were conducted in 1999 and 2004 as part of the Behavioral Risk Factor Surveillance System.

Participants in the telephone survey were asked how long it had been since they last visited a dentist or a dental clinic for any reason.

The participants who identified themselves as dentate and diabetic and who provided information about their dental visit history—approximately 21,000 respondents—were included in the data analysis.

Nationally, a median of 67% reported in the 2004 survey that they had a dental visit during the preceding 12 months—up just 1% from 66% in 1999.

Age-adjusted estimates for 2004 exceeded 71% in Kansas, Minnesota, Nebraska, Pennsylvania, Rhode Island, Utah, and Wisconsin. Significant increases over 1999 were seen in Arizona, the District of Columbia, Kansas, Minnesota, and Ohio.

The District of Columbia made the biggest strides, increasing its estimated percentage of dental patients to 71% in 2004 from just 37%—the lowest percentage in any state—in 1999.

Diabetes education programs should emphasize dental care for all people with the disease, “with emphasis on non-Hispanic blacks, persons with lower education and income, and those who lack health insurance,” the CDC stated. These groups were least likely to report dental visits.

Neuroradiologic studies can provide valuable diagnostic information in women who present during pregnancy or the puerperium with apparent eclampsia or similar neurologic manifestations, British investigators have reported.

A host of less common neurologic conditions and manifestations may mimic or resemble eclampsia and, because signs and symptoms are often nonspecific, it can be difficult to differentiate these conditions “on clinical grounds alone,” they said in a recently published pictorial review.

“Neuroimaging in a clearly defined case of eclampsia may not be necessary but, if there is focal neurology or deterioration in neurological status, imaging should be performed,” said Dr. R. Dineen of the department of neuroradiology at Queen's Medical Centre in Nottingham, England, and his associates.

Without it, the diagnosis of various conditions—from intracranial hemorrhage and other cerebrovascular conditions, to intracranial tumors and various pituitary and metabolic conditions—may be delayed as women are mistakenly treated for eclampsia, they said.

In women with true eclampsia, the most frequent abnormality detected on cranial MRI is high-signal change on T2-weighted and FLAIR images. Lesions are commonly seen in both deep and subcortical white matter, often with a posterior circulation distribution, and within the basal ganglia.

Lesions also occur within the pons and brainstem, and correspond to low-attenuation areas on CT scanning.

The majority of lesions are reversible but some may progress to infarction, the investigators said.

Several “overlap syndromes”—postpartum cerebral angiopathy, hypertensive encephalopathy, and reversible posterior leukoencephalopathy syndrome—may show neuroimaging features that are similar to or indistinguishable from those of eclampsia, the authors said (Clin. Radiol. 2005;60:1156–70).

Neuroimaging features are more distinct with other neurologic emergencies, such as the cerebrovascular disorders that can occur in pregnancy or the puerperal period: arterial ischemia and infarction, intracranial hemorrhage, venoocclusive disease, and vasculitis.

The mainstay for investigating ruptured intracranial aneurysms—the most common cause of subarachnoid hemorrhage and a cause of intracerebral hemorrhage—is CT with either CT angiography or conventional angiography. Magnetic resonance angiography, however, can be used to assess aneurysms without the need for ionizing radiation or contrast media.

Just as the risk of ruptured intracranial aneurysms increases for women who are pregnant or in the puerperal period, compared with nonpregnant women, the risk of intracranial venoocclusive disease is particularly increased around the puerperal period. Intracranial venoocclusive disease also can occur in women with pre-eclampsia.

Women with the condition present with headache, confusion, decreased consciousness level, papilledema, sei-zures, and often, focal deficits.

CT scanning shows hyperdensity in the venous sinuses, cortical veins, or deep cerebral veins. When venous infarction develops, areas of low attenuation are seen.

Patterns of venous infarction on MRI “do not conform to the contours expected from an arterial occlusion,” the investigators noted.

T2-weighted images show high-signal change involving the white matter with absent flow void in the related cortical vein or dural venous sinus.

Precautions should be taken to limit fetal exposure to ionizing radiation, however, “fetal exposure to ionizing radiation from CT of the maternal head is extremely low, and the risk to the fetus is likely to be considerably less than the risk to both the fetus and mother from an acute neurological condition,” the investigators wrote in their report.

An internal carotid catheter angiogram shows a giant intracavernous aneurysm at the underside of the C4 segment. ©Elsevier, Clinical Radiology, Vol. 60, R. Dineen, “Imaging of acute neurological conditions in pregnancy and puerperium,” 1156 - 1170, 2005. Reprinted with permission from The Royal College of Radiologists

A CT scan shows hemorrhagic venous infarction in the left temporal lobe.

Neuroradiologic studies can provide valuable diagnostic information in women who present during pregnancy or the puerperium with apparent eclampsia or similar neurologic manifestations, British investigators have reported.

A host of less common neurologic conditions and manifestations may mimic or resemble eclampsia and, because signs and symptoms are often nonspecific, it can be difficult to differentiate these conditions “on clinical grounds alone,” they said in a recently published pictorial review.

“Neuroimaging in a clearly defined case of eclampsia may not be necessary but, if there is focal neurology or deterioration in neurological status, imaging should be performed,” said Dr. R. Dineen of the department of neuroradiology at Queen's Medical Centre in Nottingham, England, and his associates.

Without it, the diagnosis of various conditions—from intracranial hemorrhage and other cerebrovascular conditions, to intracranial tumors and various pituitary and metabolic conditions—may be delayed as women are mistakenly treated for eclampsia, they said.

In women with true eclampsia, the most frequent abnormality detected on cranial MRI is high-signal change on T2-weighted and FLAIR images. Lesions are commonly seen in both deep and subcortical white matter, often with a posterior circulation distribution, and within the basal ganglia.

Lesions also occur within the pons and brainstem, and correspond to low-attenuation areas on CT scanning.

The majority of lesions are reversible but some may progress to infarction, the investigators said.

Several “overlap syndromes”—postpartum cerebral angiopathy, hypertensive encephalopathy, and reversible posterior leukoencephalopathy syndrome—may show neuroimaging features that are similar to or indistinguishable from those of eclampsia, the authors said (Clin. Radiol. 2005;60:1156–70).

Neuroimaging features are more distinct with other neurologic emergencies, such as the cerebrovascular disorders that can occur in pregnancy or the puerperal period: arterial ischemia and infarction, intracranial hemorrhage, venoocclusive disease, and vasculitis.

The mainstay for investigating ruptured intracranial aneurysms—the most common cause of subarachnoid hemorrhage and a cause of intracerebral hemorrhage—is CT with either CT angiography or conventional angiography. Magnetic resonance angiography, however, can be used to assess aneurysms without the need for ionizing radiation or contrast media.

Just as the risk of ruptured intracranial aneurysms increases for women who are pregnant or in the puerperal period, compared with nonpregnant women, the risk of intracranial venoocclusive disease is particularly increased around the puerperal period. Intracranial venoocclusive disease also can occur in women with pre-eclampsia.

Women with the condition present with headache, confusion, decreased consciousness level, papilledema, sei-zures, and often, focal deficits.

CT scanning shows hyperdensity in the venous sinuses, cortical veins, or deep cerebral veins. When venous infarction develops, areas of low attenuation are seen.

Patterns of venous infarction on MRI “do not conform to the contours expected from an arterial occlusion,” the investigators noted.

T2-weighted images show high-signal change involving the white matter with absent flow void in the related cortical vein or dural venous sinus.

Precautions should be taken to limit fetal exposure to ionizing radiation, however, “fetal exposure to ionizing radiation from CT of the maternal head is extremely low, and the risk to the fetus is likely to be considerably less than the risk to both the fetus and mother from an acute neurological condition,” the investigators wrote in their report.

An internal carotid catheter angiogram shows a giant intracavernous aneurysm at the underside of the C4 segment. ©Elsevier, Clinical Radiology, Vol. 60, R. Dineen, “Imaging of acute neurological conditions in pregnancy and puerperium,” 1156 - 1170, 2005. Reprinted with permission from The Royal College of Radiologists

A CT scan shows hemorrhagic venous infarction in the left temporal lobe.

Neuroradiologic studies can provide valuable diagnostic information in women who present during pregnancy or the puerperium with apparent eclampsia or similar neurologic manifestations, British investigators have reported.

A host of less common neurologic conditions and manifestations may mimic or resemble eclampsia and, because signs and symptoms are often nonspecific, it can be difficult to differentiate these conditions “on clinical grounds alone,” they said in a recently published pictorial review.

“Neuroimaging in a clearly defined case of eclampsia may not be necessary but, if there is focal neurology or deterioration in neurological status, imaging should be performed,” said Dr. R. Dineen of the department of neuroradiology at Queen's Medical Centre in Nottingham, England, and his associates.

Without it, the diagnosis of various conditions—from intracranial hemorrhage and other cerebrovascular conditions, to intracranial tumors and various pituitary and metabolic conditions—may be delayed as women are mistakenly treated for eclampsia, they said.

In women with true eclampsia, the most frequent abnormality detected on cranial MRI is high-signal change on T2-weighted and FLAIR images. Lesions are commonly seen in both deep and subcortical white matter, often with a posterior circulation distribution, and within the basal ganglia.

Lesions also occur within the pons and brainstem, and correspond to low-attenuation areas on CT scanning.

The majority of lesions are reversible but some may progress to infarction, the investigators said.

Several “overlap syndromes”—postpartum cerebral angiopathy, hypertensive encephalopathy, and reversible posterior leukoencephalopathy syndrome—may show neuroimaging features that are similar to or indistinguishable from those of eclampsia, the authors said (Clin. Radiol. 2005;60:1156–70).

Neuroimaging features are more distinct with other neurologic emergencies, such as the cerebrovascular disorders that can occur in pregnancy or the puerperal period: arterial ischemia and infarction, intracranial hemorrhage, venoocclusive disease, and vasculitis.

The mainstay for investigating ruptured intracranial aneurysms—the most common cause of subarachnoid hemorrhage and a cause of intracerebral hemorrhage—is CT with either CT angiography or conventional angiography. Magnetic resonance angiography, however, can be used to assess aneurysms without the need for ionizing radiation or contrast media.

Just as the risk of ruptured intracranial aneurysms increases for women who are pregnant or in the puerperal period, compared with nonpregnant women, the risk of intracranial venoocclusive disease is particularly increased around the puerperal period. Intracranial venoocclusive disease also can occur in women with pre-eclampsia.

Women with the condition present with headache, confusion, decreased consciousness level, papilledema, sei-zures, and often, focal deficits.

CT scanning shows hyperdensity in the venous sinuses, cortical veins, or deep cerebral veins. When venous infarction develops, areas of low attenuation are seen.

Patterns of venous infarction on MRI “do not conform to the contours expected from an arterial occlusion,” the investigators noted.

T2-weighted images show high-signal change involving the white matter with absent flow void in the related cortical vein or dural venous sinus.

Precautions should be taken to limit fetal exposure to ionizing radiation, however, “fetal exposure to ionizing radiation from CT of the maternal head is extremely low, and the risk to the fetus is likely to be considerably less than the risk to both the fetus and mother from an acute neurological condition,” the investigators wrote in their report.

An internal carotid catheter angiogram shows a giant intracavernous aneurysm at the underside of the C4 segment. ©Elsevier, Clinical Radiology, Vol. 60, R. Dineen, “Imaging of acute neurological conditions in pregnancy and puerperium,” 1156 - 1170, 2005. Reprinted with permission from The Royal College of Radiologists

A CT scan shows hemorrhagic venous infarction in the left temporal lobe.

Neuroradiologic studies can provide valuable diagnostic information in women who present during pregnancy or the puerperium with apparent eclampsia or similar neurologic manifestations, British investigators have reported.

A host of less common neurologic conditions and manifestations may mimic or resemble eclampsia and, because signs and symptoms are often nonspecific, it can be difficult to differentiate these conditions “on clinical grounds alone,” they said in a recently published pictorial review.

“Neuroimaging in a clearly defined case of eclampsia may not be necessary but, if there is focal neurology or deterioration in neurological status, imaging should be performed,” said Dr. R. Dineen of the department of neuroradiology at Queen's Medical Centre in Nottingham, England, and his associates.

Without it, the diagnosis of various conditions—from intracranial hemorrhage and other cerebrovascular conditions, to intracranial tumors and various pituitary and metabolic conditions—may be delayed as women are mistakenly treated for eclampsia, they said.

In women with true eclampsia, the most frequent abnormality detected on cranial MRI is high-signal change on T2-weighted and FLAIR images. Lesions are commonly seen in both deep and subcortical white matter, often with a posterior circulation distribution, and within the basal ganglia.

Lesions also occur within the pons and brainstem, and correspond to low-attenuation areas on CT scanning. The majority of lesions are reversible but some may progress to infarction, they said.

Several “overlap syndromes”—postpartum cerebral angiopathy, hypertensive encephalopathy, and reversible posterior leukoencephalopathy syndrome—may show neuroimaging features that are similar to or indistinguishable from those of eclampsia, they said (Clin. Radiol. 2005;60:1156-70).

Neuroimaging features are more distinct with other neurologic emergencies, such as the cerebrovascular disorders that can occur in pregnancy or the puerperal period: arterial ischemia and infarction, intracranial hemorrhage, venoocclusive disease, and vasculitis.

The mainstay for investigating ruptured intracranial aneurysms—the most common cause of subarachnoid hemorrhage and a cause of intracerebral hemorrhage—is CT with either CT angiography or conventional angiography. Magnetic resonance angiography, however, can be used to assess aneurysms without the need for ionizing radiation or contrast media.

Just as the risk of ruptured intracranial aneurysms increases for women who are pregnant or in the puerperal period, compared with nonpregnant women, the risk of intracranial venoocclusive disease is particularly increased around the puerperal period. Intracranial venoocclusive disease also can occur in women with preeclampsia.

Women with the condition present with headache, confusion, decreased consciousness level, papilledema, seizures, and often, focal deficits.

CT scanning shows hyperdensity in the venous sinuses, cortical veins, or deep cerebral veins. When venous infarction develops, areas of low attenuation are seen. Patterns of venous infarction on MRI “do not conform to the contours expected from an arterial occlusion,” the investigators note. T2-weighted images show high-signal change involving the white matter with absent flow void in the related cortical vein or dural venous sinus.

Precautions should be taken to limit fetal exposure to ionizing radiation, but “fetal exposure to ionizing radiation from CT of the maternal head is extremely low, and the risk to the fetus is likely to be considerably less than the risk to both the fetus and mother from an acute neurological condition,” the investigators reported.

An internal carotid catheter angiogram shows a giant intracavernous aneurysm at the underside of the C4 segment.

A CT shows high density in the left transverse sinus and hemorrhagic venous infarction in the left temporal lobe. ©Elsevier, Clinical Radiology, Vol. 60, R. Dineen, “Imaging of acute neurological conditions in pregnancy and puerperium,” 1156 - 1170, 2005, Reprinted with permission from The Royal College of Radiologists

Neuroradiologic studies can provide valuable diagnostic information in women who present during pregnancy or the puerperium with apparent eclampsia or similar neurologic manifestations, British investigators have reported.

A host of less common neurologic conditions and manifestations may mimic or resemble eclampsia and, because signs and symptoms are often nonspecific, it can be difficult to differentiate these conditions “on clinical grounds alone,” they said in a recently published pictorial review.

“Neuroimaging in a clearly defined case of eclampsia may not be necessary but, if there is focal neurology or deterioration in neurological status, imaging should be performed,” said Dr. R. Dineen of the department of neuroradiology at Queen's Medical Centre in Nottingham, England, and his associates.

Without it, the diagnosis of various conditions—from intracranial hemorrhage and other cerebrovascular conditions, to intracranial tumors and various pituitary and metabolic conditions—may be delayed as women are mistakenly treated for eclampsia, they said.

In women with true eclampsia, the most frequent abnormality detected on cranial MRI is high-signal change on T2-weighted and FLAIR images. Lesions are commonly seen in both deep and subcortical white matter, often with a posterior circulation distribution, and within the basal ganglia.

Lesions also occur within the pons and brainstem, and correspond to low-attenuation areas on CT scanning. The majority of lesions are reversible but some may progress to infarction, they said.

Several “overlap syndromes”—postpartum cerebral angiopathy, hypertensive encephalopathy, and reversible posterior leukoencephalopathy syndrome—may show neuroimaging features that are similar to or indistinguishable from those of eclampsia, they said (Clin. Radiol. 2005;60:1156-70).

Neuroimaging features are more distinct with other neurologic emergencies, such as the cerebrovascular disorders that can occur in pregnancy or the puerperal period: arterial ischemia and infarction, intracranial hemorrhage, venoocclusive disease, and vasculitis.

The mainstay for investigating ruptured intracranial aneurysms—the most common cause of subarachnoid hemorrhage and a cause of intracerebral hemorrhage—is CT with either CT angiography or conventional angiography. Magnetic resonance angiography, however, can be used to assess aneurysms without the need for ionizing radiation or contrast media.

Just as the risk of ruptured intracranial aneurysms increases for women who are pregnant or in the puerperal period, compared with nonpregnant women, the risk of intracranial venoocclusive disease is particularly increased around the puerperal period. Intracranial venoocclusive disease also can occur in women with preeclampsia.

Women with the condition present with headache, confusion, decreased consciousness level, papilledema, seizures, and often, focal deficits.

CT scanning shows hyperdensity in the venous sinuses, cortical veins, or deep cerebral veins. When venous infarction develops, areas of low attenuation are seen. Patterns of venous infarction on MRI “do not conform to the contours expected from an arterial occlusion,” the investigators note. T2-weighted images show high-signal change involving the white matter with absent flow void in the related cortical vein or dural venous sinus.

Precautions should be taken to limit fetal exposure to ionizing radiation, but “fetal exposure to ionizing radiation from CT of the maternal head is extremely low, and the risk to the fetus is likely to be considerably less than the risk to both the fetus and mother from an acute neurological condition,” the investigators reported.

An internal carotid catheter angiogram shows a giant intracavernous aneurysm at the underside of the C4 segment.

A CT shows high density in the left transverse sinus and hemorrhagic venous infarction in the left temporal lobe. ©Elsevier, Clinical Radiology, Vol. 60, R. Dineen, “Imaging of acute neurological conditions in pregnancy and puerperium,” 1156 - 1170, 2005, Reprinted with permission from The Royal College of Radiologists

Neuroradiologic studies can provide valuable diagnostic information in women who present during pregnancy or the puerperium with apparent eclampsia or similar neurologic manifestations, British investigators have reported.

A host of less common neurologic conditions and manifestations may mimic or resemble eclampsia and, because signs and symptoms are often nonspecific, it can be difficult to differentiate these conditions “on clinical grounds alone,” they said in a recently published pictorial review.

“Neuroimaging in a clearly defined case of eclampsia may not be necessary but, if there is focal neurology or deterioration in neurological status, imaging should be performed,” said Dr. R. Dineen of the department of neuroradiology at Queen's Medical Centre in Nottingham, England, and his associates.

Without it, the diagnosis of various conditions—from intracranial hemorrhage and other cerebrovascular conditions, to intracranial tumors and various pituitary and metabolic conditions—may be delayed as women are mistakenly treated for eclampsia, they said.

In women with true eclampsia, the most frequent abnormality detected on cranial MRI is high-signal change on T2-weighted and FLAIR images. Lesions are commonly seen in both deep and subcortical white matter, often with a posterior circulation distribution, and within the basal ganglia.

Lesions also occur within the pons and brainstem, and correspond to low-attenuation areas on CT scanning. The majority of lesions are reversible but some may progress to infarction, they said.

Several “overlap syndromes”—postpartum cerebral angiopathy, hypertensive encephalopathy, and reversible posterior leukoencephalopathy syndrome—may show neuroimaging features that are similar to or indistinguishable from those of eclampsia, they said (Clin. Radiol. 2005;60:1156-70).

Neuroimaging features are more distinct with other neurologic emergencies, such as the cerebrovascular disorders that can occur in pregnancy or the puerperal period: arterial ischemia and infarction, intracranial hemorrhage, venoocclusive disease, and vasculitis.

The mainstay for investigating ruptured intracranial aneurysms—the most common cause of subarachnoid hemorrhage and a cause of intracerebral hemorrhage—is CT with either CT angiography or conventional angiography. Magnetic resonance angiography, however, can be used to assess aneurysms without the need for ionizing radiation or contrast media.

Just as the risk of ruptured intracranial aneurysms increases for women who are pregnant or in the puerperal period, compared with nonpregnant women, the risk of intracranial venoocclusive disease is particularly increased around the puerperal period. Intracranial venoocclusive disease also can occur in women with preeclampsia.

Women with the condition present with headache, confusion, decreased consciousness level, papilledema, seizures, and often, focal deficits.

CT scanning shows hyperdensity in the venous sinuses, cortical veins, or deep cerebral veins. When venous infarction develops, areas of low attenuation are seen. Patterns of venous infarction on MRI “do not conform to the contours expected from an arterial occlusion,” the investigators note. T2-weighted images show high-signal change involving the white matter with absent flow void in the related cortical vein or dural venous sinus.

Precautions should be taken to limit fetal exposure to ionizing radiation, but “fetal exposure to ionizing radiation from CT of the maternal head is extremely low, and the risk to the fetus is likely to be considerably less than the risk to both the fetus and mother from an acute neurological condition,” the investigators reported.

An internal carotid catheter angiogram shows a giant intracavernous aneurysm at the underside of the C4 segment.

A CT shows high density in the left transverse sinus and hemorrhagic venous infarction in the left temporal lobe. ©Elsevier, Clinical Radiology, Vol. 60, R. Dineen, “Imaging of acute neurological conditions in pregnancy and puerperium,” 1156 - 1170, 2005, Reprinted with permission from The Royal College of Radiologists

The jury is still out, but for now there is no clear evidence that statins or fibrates can decrease the risk of melanoma, according to a new review of studies conducted by The Cochrane Collaboration.

Investigators for the international organization, which conducts systematic reviews and issues evidence-based conclusions about medical practice, identified 16 qualifying randomized controlled trials (7 on statins, 9 on fibrates), 13 of which provided data on incident melanomas. Investigators also requested unpublished melanoma outcomes data from study authors.

There were 66 reported melanomas in patients receiving the experimental drug and 86 in patients receiving placebo and other control therapies in the trials, which included more than 62,000 patients, according to the Cochrane review.

The outcomes data “[do] not exclude the possibility that these drugs prevent melanoma,” since there was a 10% and 42% reduction in melanoma for patients taking statins and fibrates, respectively, the investigators say in the review, which was led by Dr. Robert Dellavalle of Denver Veterans Affairs Medical Center.

The results were not statistically significant, however, and trials of cancer and statins should continue in order to further address suggestions raised by case-control, in vitro, and animal model studies.

The trials included in the review all involved random allocation of study participants, the use of statins or fibrates in isolation in the studies' experimental groups, and the administration of therapy for at least 4 years.

The jury is still out, but for now there is no clear evidence that statins or fibrates can decrease the risk of melanoma, according to a new review of studies conducted by The Cochrane Collaboration.

Investigators for the international organization, which conducts systematic reviews and issues evidence-based conclusions about medical practice, identified 16 qualifying randomized controlled trials (7 on statins, 9 on fibrates), 13 of which provided data on incident melanomas. Investigators also requested unpublished melanoma outcomes data from study authors.

There were 66 reported melanomas in patients receiving the experimental drug and 86 in patients receiving placebo and other control therapies in the trials, which included more than 62,000 patients, according to the Cochrane review.

The outcomes data “[do] not exclude the possibility that these drugs prevent melanoma,” since there was a 10% and 42% reduction in melanoma for patients taking statins and fibrates, respectively, the investigators say in the review, which was led by Dr. Robert Dellavalle of Denver Veterans Affairs Medical Center.

The results were not statistically significant, however, and trials of cancer and statins should continue in order to further address suggestions raised by case-control, in vitro, and animal model studies.

The trials included in the review all involved random allocation of study participants, the use of statins or fibrates in isolation in the studies' experimental groups, and the administration of therapy for at least 4 years.

The jury is still out, but for now there is no clear evidence that statins or fibrates can decrease the risk of melanoma, according to a new review of studies conducted by The Cochrane Collaboration.

Investigators for the international organization, which conducts systematic reviews and issues evidence-based conclusions about medical practice, identified 16 qualifying randomized controlled trials (7 on statins, 9 on fibrates), 13 of which provided data on incident melanomas. Investigators also requested unpublished melanoma outcomes data from study authors.

There were 66 reported melanomas in patients receiving the experimental drug and 86 in patients receiving placebo and other control therapies in the trials, which included more than 62,000 patients, according to the Cochrane review.

The outcomes data “[do] not exclude the possibility that these drugs prevent melanoma,” since there was a 10% and 42% reduction in melanoma for patients taking statins and fibrates, respectively, the investigators say in the review, which was led by Dr. Robert Dellavalle of Denver Veterans Affairs Medical Center.

The results were not statistically significant, however, and trials of cancer and statins should continue in order to further address suggestions raised by case-control, in vitro, and animal model studies.

The trials included in the review all involved random allocation of study participants, the use of statins or fibrates in isolation in the studies' experimental groups, and the administration of therapy for at least 4 years.

Patients with hand osteoarthritis are significantly more likely to develop disease of the hip or knee later in life, a prospective, population-based study has shown.

The new findings are consistent with reports that osteoarthritis (OA) is a generalized disease in many patients, and suggest that by “identifying subjects who have a tendency for developing OA and by modifying their risk factors, it may be possible to avoid or prevent OA-related pain and disability in the weight-bearing joints,” the investigators said.

They followed 1,235 patients who had baseline radiographs of the hand, hips, and knees that showed no prevalent OA of the hip or knee (a Kellgren/Lawrence score of 0–1) and either hand OA (a Kellgren/Lawrence score of 2–4 in two of three joint groups of either hand) or no hand OA. At a mean of 6.6 years later, they obtained hip and knee radiographs again.

Independent of other known risk factors, patients with hand OA at baseline were 3 times more likely to have future hip OA and 1.6 times more likely to have future knee OA, than patients without hand OA, reported S. Dahaghin, M.D., and colleagues at the Erasmus Medical Center at the University Medical Center Rotterdam, the Netherlands (Arthritis Rheum. 2005:52;3520–7).

When they restricted their analysis to patients without any possibility of hip or knee OA at baseline (Kellgren/Lawrence score of 0, versus 0–1), they found the risk of future knee OA was the same (odds ratio 1.6) and that the risk of future hip OA was even higher (odds ratio 6.5).

Family history of OA increased the risk of future hip OA even further in patients who had hand OA at baseline. The risk of future knee OA in these patients was further increased not by family history, but when they were overweight.

Additionally, the investigators found that high baseline levels of the OA biomarker CTX-II (type II collagen C-telopeptide degradation product) increased the risk of hip and knee OA, independent of the baseline presence of hand OA or “doubtful” hip or knee OA.

Patients in the study had a mean age of 66 years. They were a randomly selected subset of participants in the Rotterdam Study, a prospective, population-based cohort study of chronic diseases in the elderly.

Patients with hand osteoarthritis are significantly more likely to develop disease of the hip or knee later in life, a prospective, population-based study has shown.

The new findings are consistent with reports that osteoarthritis (OA) is a generalized disease in many patients, and suggest that by “identifying subjects who have a tendency for developing OA and by modifying their risk factors, it may be possible to avoid or prevent OA-related pain and disability in the weight-bearing joints,” the investigators said.

They followed 1,235 patients who had baseline radiographs of the hand, hips, and knees that showed no prevalent OA of the hip or knee (a Kellgren/Lawrence score of 0–1) and either hand OA (a Kellgren/Lawrence score of 2–4 in two of three joint groups of either hand) or no hand OA. At a mean of 6.6 years later, they obtained hip and knee radiographs again.

Independent of other known risk factors, patients with hand OA at baseline were 3 times more likely to have future hip OA and 1.6 times more likely to have future knee OA, than patients without hand OA, reported S. Dahaghin, M.D., and colleagues at the Erasmus Medical Center at the University Medical Center Rotterdam, the Netherlands (Arthritis Rheum. 2005:52;3520–7).

When they restricted their analysis to patients without any possibility of hip or knee OA at baseline (Kellgren/Lawrence score of 0, versus 0–1), they found the risk of future knee OA was the same (odds ratio 1.6) and that the risk of future hip OA was even higher (odds ratio 6.5).

Family history of OA increased the risk of future hip OA even further in patients who had hand OA at baseline. The risk of future knee OA in these patients was further increased not by family history, but when they were overweight.

Additionally, the investigators found that high baseline levels of the OA biomarker CTX-II (type II collagen C-telopeptide degradation product) increased the risk of hip and knee OA, independent of the baseline presence of hand OA or “doubtful” hip or knee OA.

Patients in the study had a mean age of 66 years. They were a randomly selected subset of participants in the Rotterdam Study, a prospective, population-based cohort study of chronic diseases in the elderly.

Patients with hand osteoarthritis are significantly more likely to develop disease of the hip or knee later in life, a prospective, population-based study has shown.

The new findings are consistent with reports that osteoarthritis (OA) is a generalized disease in many patients, and suggest that by “identifying subjects who have a tendency for developing OA and by modifying their risk factors, it may be possible to avoid or prevent OA-related pain and disability in the weight-bearing joints,” the investigators said.

They followed 1,235 patients who had baseline radiographs of the hand, hips, and knees that showed no prevalent OA of the hip or knee (a Kellgren/Lawrence score of 0–1) and either hand OA (a Kellgren/Lawrence score of 2–4 in two of three joint groups of either hand) or no hand OA. At a mean of 6.6 years later, they obtained hip and knee radiographs again.

Independent of other known risk factors, patients with hand OA at baseline were 3 times more likely to have future hip OA and 1.6 times more likely to have future knee OA, than patients without hand OA, reported S. Dahaghin, M.D., and colleagues at the Erasmus Medical Center at the University Medical Center Rotterdam, the Netherlands (Arthritis Rheum. 2005:52;3520–7).

When they restricted their analysis to patients without any possibility of hip or knee OA at baseline (Kellgren/Lawrence score of 0, versus 0–1), they found the risk of future knee OA was the same (odds ratio 1.6) and that the risk of future hip OA was even higher (odds ratio 6.5).

Family history of OA increased the risk of future hip OA even further in patients who had hand OA at baseline. The risk of future knee OA in these patients was further increased not by family history, but when they were overweight.

Additionally, the investigators found that high baseline levels of the OA biomarker CTX-II (type II collagen C-telopeptide degradation product) increased the risk of hip and knee OA, independent of the baseline presence of hand OA or “doubtful” hip or knee OA.

Patients in the study had a mean age of 66 years. They were a randomly selected subset of participants in the Rotterdam Study, a prospective, population-based cohort study of chronic diseases in the elderly.

MONTREAL — Three out of four commonly used vaginal lubricants caused significant decreases in sperm motility in a prospective, controlled study—and it appears that these and other lubricants can impact chromatin integrity as well, Ashok Agarwal, Ph.D., reported.

“These lubricants may impact the fertilization process and cause a failure of fertilization,” he said at the annual meeting of the American Society for Reproductive Medicine and the Canadian Fertility and Andrology Society.

Of the approximately 11 million couples in the United States who are trying to conceive—6 million of whom have been trying for more than 1 year—an estimated 75% experience an increased incidence of vaginal dryness, Dr. Agarwal told this newspaper, referring in part to data from the National Center for Health Statistics and the Centers for Disease Control and Prevention.

The researchers collected sperm either incubated at 37° C in human tubal fluid (HTF) media (the controls) or in 10% lubricant treatments made with the lubricant samples from normal donors and diluted these samples to 20–40 × 10

In one part of the study, sperm samples from 13 donors were either incubated at 37° C in HTF (the controls) or in 10% lubricant treatments made with the lubricants marketed as Astroglide, FemGlide, Pre-Seed, and Replens. After 30 minutes of culture, the mean percentage of progressively motile sperm differed significantly between the controls and three of the four lubricant groups.

Sperm exposed to FemGlide, for instance, were 22% less motile than sperm incubated in HTF.

There were even greater decreases in motility—an 89% decrease and a 60% decrease—in sperm exposed to Replens and Astroglide, respectively, compared with sperm in the control group, reported Dr. Agarwal, director of the Clinical Andrology Laboratory and Reproductive Research Center at the Cleveland Clinic.

In the second part of the study, sperm from 12 donors were processed in the same way and placed in either HTF or 10% KY Jelly, FemGlide, or Pre-Seed. The sperm were cultured for 4 hours to evaluate sperm chromatic integrity after longer exposure to lubricants.

There was no significant difference in the percent damaged chromatin between the HTF control group and the Pre-Seed group. There was a 15% and a 10% increase in DFI after exposure to FemGlide and KY, respectively, compared with control.

Because the lubricant Pre-Seed caused little difference in either sperm motility or chromatin integrity, compared with controls, “we can say that, from our study, this particular compound does appear to fare much better,” he said. “But there should be more studies done in other centers that involve larger numbers of patients.”

The study was conducted with all lubricants provided by INGfertility Inc., the manufacturer of Pre-Seed, Dr. Agarwal said. He reported no conflicts of interest.

Kate Johnson of the Montreal Bureau contributed to this report.

MONTREAL — Three out of four commonly used vaginal lubricants caused significant decreases in sperm motility in a prospective, controlled study—and it appears that these and other lubricants can impact chromatin integrity as well, Ashok Agarwal, Ph.D., reported.

“These lubricants may impact the fertilization process and cause a failure of fertilization,” he said at the annual meeting of the American Society for Reproductive Medicine and the Canadian Fertility and Andrology Society.

Of the approximately 11 million couples in the United States who are trying to conceive—6 million of whom have been trying for more than 1 year—an estimated 75% experience an increased incidence of vaginal dryness, Dr. Agarwal told this newspaper, referring in part to data from the National Center for Health Statistics and the Centers for Disease Control and Prevention.

The researchers collected sperm either incubated at 37° C in human tubal fluid (HTF) media (the controls) or in 10% lubricant treatments made with the lubricant samples from normal donors and diluted these samples to 20–40 × 10

In one part of the study, sperm samples from 13 donors were either incubated at 37° C in HTF (the controls) or in 10% lubricant treatments made with the lubricants marketed as Astroglide, FemGlide, Pre-Seed, and Replens. After 30 minutes of culture, the mean percentage of progressively motile sperm differed significantly between the controls and three of the four lubricant groups.

Sperm exposed to FemGlide, for instance, were 22% less motile than sperm incubated in HTF.

There were even greater decreases in motility—an 89% decrease and a 60% decrease—in sperm exposed to Replens and Astroglide, respectively, compared with sperm in the control group, reported Dr. Agarwal, director of the Clinical Andrology Laboratory and Reproductive Research Center at the Cleveland Clinic.

In the second part of the study, sperm from 12 donors were processed in the same way and placed in either HTF or 10% KY Jelly, FemGlide, or Pre-Seed. The sperm were cultured for 4 hours to evaluate sperm chromatic integrity after longer exposure to lubricants.

There was no significant difference in the percent damaged chromatin between the HTF control group and the Pre-Seed group. There was a 15% and a 10% increase in DFI after exposure to FemGlide and KY, respectively, compared with control.

Because the lubricant Pre-Seed caused little difference in either sperm motility or chromatin integrity, compared with controls, “we can say that, from our study, this particular compound does appear to fare much better,” he said. “But there should be more studies done in other centers that involve larger numbers of patients.”

The study was conducted with all lubricants provided by INGfertility Inc., the manufacturer of Pre-Seed, Dr. Agarwal said. He reported no conflicts of interest.

Kate Johnson of the Montreal Bureau contributed to this report.

MONTREAL — Three out of four commonly used vaginal lubricants caused significant decreases in sperm motility in a prospective, controlled study—and it appears that these and other lubricants can impact chromatin integrity as well, Ashok Agarwal, Ph.D., reported.

“These lubricants may impact the fertilization process and cause a failure of fertilization,” he said at the annual meeting of the American Society for Reproductive Medicine and the Canadian Fertility and Andrology Society.

Of the approximately 11 million couples in the United States who are trying to conceive—6 million of whom have been trying for more than 1 year—an estimated 75% experience an increased incidence of vaginal dryness, Dr. Agarwal told this newspaper, referring in part to data from the National Center for Health Statistics and the Centers for Disease Control and Prevention.

The researchers collected sperm either incubated at 37° C in human tubal fluid (HTF) media (the controls) or in 10% lubricant treatments made with the lubricant samples from normal donors and diluted these samples to 20–40 × 10

In one part of the study, sperm samples from 13 donors were either incubated at 37° C in HTF (the controls) or in 10% lubricant treatments made with the lubricants marketed as Astroglide, FemGlide, Pre-Seed, and Replens. After 30 minutes of culture, the mean percentage of progressively motile sperm differed significantly between the controls and three of the four lubricant groups.

Sperm exposed to FemGlide, for instance, were 22% less motile than sperm incubated in HTF.

There were even greater decreases in motility—an 89% decrease and a 60% decrease—in sperm exposed to Replens and Astroglide, respectively, compared with sperm in the control group, reported Dr. Agarwal, director of the Clinical Andrology Laboratory and Reproductive Research Center at the Cleveland Clinic.

In the second part of the study, sperm from 12 donors were processed in the same way and placed in either HTF or 10% KY Jelly, FemGlide, or Pre-Seed. The sperm were cultured for 4 hours to evaluate sperm chromatic integrity after longer exposure to lubricants.

There was no significant difference in the percent damaged chromatin between the HTF control group and the Pre-Seed group. There was a 15% and a 10% increase in DFI after exposure to FemGlide and KY, respectively, compared with control.

Because the lubricant Pre-Seed caused little difference in either sperm motility or chromatin integrity, compared with controls, “we can say that, from our study, this particular compound does appear to fare much better,” he said. “But there should be more studies done in other centers that involve larger numbers of patients.”

The study was conducted with all lubricants provided by INGfertility Inc., the manufacturer of Pre-Seed, Dr. Agarwal said. He reported no conflicts of interest.

Kate Johnson of the Montreal Bureau contributed to this report.

Low doses of prednisolone given for 2 years along with disease-modifying antirheumatic drug therapy substantially and safely reduced radiographic progression of rheumatoid arthritis in patients with early, active disease, according to the results of two new randomized studies.

Investigators of the two studies say that their findings support the use of low-dose daily prednisolone as a low-risk adjunct to DMARDs in patients with early RA.

One study compared the addition of 7.5 mg/day prednisolone to initial DMARD therapy (either methotrexate or sulfasalazine) with DMARD therapy alone in 250 patients recruited in six centers throughout Sweden from 1995 to 1999. The patients had had RA for 1 year or less.

Patients in the second study were randomized to receive placebo or an even smaller dose of prednisolone—5 mg/day—in addition to therapy with either gold sodium thiomalate or methotrexate.

The 103 patients who completed this study had a slightly longer disease duration—2 years or less—when they started treatment.

They were enrolled in the study between 1993 and 1995 in 20 clinics and private practices in Germany, Austria, and Switzerland.

The two studies were similar in that the choice of DMARD therapy was left to the treating physician. There were no significant differences, however, in the types and dosages of DMARD therapy between the patients who were randomized to receive prednisolone and those who received placebo or no prednisolone.

Concomitant treatment with NSAIDs and osteoporosis prophylaxis with calcium was allowed in both studies, and patients with any history of treatment with DMARDs or glucocorticoids were excluded. Joint destruction was monitored in both studies primarily through radiographs of the hands and feet.

The Swedish investigators used the Sharp score as modified by van der Heijde to assess radiographs at baseline and after 1 and 2 years of treatment. The change in the total score, they found, was significantly lower after 1 and 2 years in the prednisolone group than in the no-prednisolone group. (At 2 years, for instance, the median interquartile change in total score was 1.8 and 3.5, respectively.)

The erosion score also changed significantly less in the prednisolone group, and joint space narrowing was retarded, though to a lesser extent than erosion.

Patients in the prednisolone group also had significantly fewer newly eroded joints after 2 years, as well as improved physical functioning and significantly higher rates of disease remission (51% vs. 39% in the no-prednisolone group at 1 year, and 56% vs. 33% at 2 years), reported Björn Svensson, M.D., Ph.D., of the University of Lund (Sweden), and his associates (Arthritis Rheum. 2005:52;3360–70).

Investigators in the multicountry study used two scoring systems—the Ratingen score and the modified Sharp/van der Heijde score—to assess radiographs taken at 6 months, 1 year, and 2 years after the start of treatment.

Their results were similar: Increases in the Ratingen score, the Sharp score for erosion, and the total Sharp score were significantly less at each point in time in patients taking prednisolone than in patients taking placebo. Changes in the score for joint space narrowing were significantly different only at 6 months.

In addition, clinical and functional outcomes, as well as rates of disease remission, tended to be better—though not to the level of statistical significance—in the prednisolone group, reported Siegfried Wassenberg, M.D., of Evangelisches Fachkrankenhaus Ratingen (Germany), and his associates (Arthritis Rheum. 2005:52;3371–80).

Some side effects such as weight gain (four patients), hypertension (six), Cushing's syndrome (five), and glaucoma (three) were reported only among patients taking prednisolone.

In the Swedish study, the frequency of adverse events was small, investigators said. And in both studies, prednisolone had little or no impact on bone loss.

“It remains to be seen whether dosages lower than 5 mg provide the same benefit with even fewer side effects and whether the same effect can be produced in patients with more advanced disease,” Dr. Wassenberg and associates said.

Low doses of prednisolone given for 2 years along with disease-modifying antirheumatic drug therapy substantially and safely reduced radiographic progression of rheumatoid arthritis in patients with early, active disease, according to the results of two new randomized studies.

Investigators of the two studies say that their findings support the use of low-dose daily prednisolone as a low-risk adjunct to DMARDs in patients with early RA.

One study compared the addition of 7.5 mg/day prednisolone to initial DMARD therapy (either methotrexate or sulfasalazine) with DMARD therapy alone in 250 patients recruited in six centers throughout Sweden from 1995 to 1999. The patients had had RA for 1 year or less.

Patients in the second study were randomized to receive placebo or an even smaller dose of prednisolone—5 mg/day—in addition to therapy with either gold sodium thiomalate or methotrexate.

The 103 patients who completed this study had a slightly longer disease duration—2 years or less—when they started treatment.

They were enrolled in the study between 1993 and 1995 in 20 clinics and private practices in Germany, Austria, and Switzerland.

The two studies were similar in that the choice of DMARD therapy was left to the treating physician. There were no significant differences, however, in the types and dosages of DMARD therapy between the patients who were randomized to receive prednisolone and those who received placebo or no prednisolone.

Concomitant treatment with NSAIDs and osteoporosis prophylaxis with calcium was allowed in both studies, and patients with any history of treatment with DMARDs or glucocorticoids were excluded. Joint destruction was monitored in both studies primarily through radiographs of the hands and feet.

The Swedish investigators used the Sharp score as modified by van der Heijde to assess radiographs at baseline and after 1 and 2 years of treatment. The change in the total score, they found, was significantly lower after 1 and 2 years in the prednisolone group than in the no-prednisolone group. (At 2 years, for instance, the median interquartile change in total score was 1.8 and 3.5, respectively.)

The erosion score also changed significantly less in the prednisolone group, and joint space narrowing was retarded, though to a lesser extent than erosion.

Patients in the prednisolone group also had significantly fewer newly eroded joints after 2 years, as well as improved physical functioning and significantly higher rates of disease remission (51% vs. 39% in the no-prednisolone group at 1 year, and 56% vs. 33% at 2 years), reported Björn Svensson, M.D., Ph.D., of the University of Lund (Sweden), and his associates (Arthritis Rheum. 2005:52;3360–70).

Investigators in the multicountry study used two scoring systems—the Ratingen score and the modified Sharp/van der Heijde score—to assess radiographs taken at 6 months, 1 year, and 2 years after the start of treatment.

Their results were similar: Increases in the Ratingen score, the Sharp score for erosion, and the total Sharp score were significantly less at each point in time in patients taking prednisolone than in patients taking placebo. Changes in the score for joint space narrowing were significantly different only at 6 months.

In addition, clinical and functional outcomes, as well as rates of disease remission, tended to be better—though not to the level of statistical significance—in the prednisolone group, reported Siegfried Wassenberg, M.D., of Evangelisches Fachkrankenhaus Ratingen (Germany), and his associates (Arthritis Rheum. 2005:52;3371–80).

Some side effects such as weight gain (four patients), hypertension (six), Cushing's syndrome (five), and glaucoma (three) were reported only among patients taking prednisolone.

In the Swedish study, the frequency of adverse events was small, investigators said. And in both studies, prednisolone had little or no impact on bone loss.

“It remains to be seen whether dosages lower than 5 mg provide the same benefit with even fewer side effects and whether the same effect can be produced in patients with more advanced disease,” Dr. Wassenberg and associates said.

Low doses of prednisolone given for 2 years along with disease-modifying antirheumatic drug therapy substantially and safely reduced radiographic progression of rheumatoid arthritis in patients with early, active disease, according to the results of two new randomized studies.

Investigators of the two studies say that their findings support the use of low-dose daily prednisolone as a low-risk adjunct to DMARDs in patients with early RA.

One study compared the addition of 7.5 mg/day prednisolone to initial DMARD therapy (either methotrexate or sulfasalazine) with DMARD therapy alone in 250 patients recruited in six centers throughout Sweden from 1995 to 1999. The patients had had RA for 1 year or less.

Patients in the second study were randomized to receive placebo or an even smaller dose of prednisolone—5 mg/day—in addition to therapy with either gold sodium thiomalate or methotrexate.

The 103 patients who completed this study had a slightly longer disease duration—2 years or less—when they started treatment.

They were enrolled in the study between 1993 and 1995 in 20 clinics and private practices in Germany, Austria, and Switzerland.

The two studies were similar in that the choice of DMARD therapy was left to the treating physician. There were no significant differences, however, in the types and dosages of DMARD therapy between the patients who were randomized to receive prednisolone and those who received placebo or no prednisolone.

Concomitant treatment with NSAIDs and osteoporosis prophylaxis with calcium was allowed in both studies, and patients with any history of treatment with DMARDs or glucocorticoids were excluded. Joint destruction was monitored in both studies primarily through radiographs of the hands and feet.

The Swedish investigators used the Sharp score as modified by van der Heijde to assess radiographs at baseline and after 1 and 2 years of treatment. The change in the total score, they found, was significantly lower after 1 and 2 years in the prednisolone group than in the no-prednisolone group. (At 2 years, for instance, the median interquartile change in total score was 1.8 and 3.5, respectively.)

The erosion score also changed significantly less in the prednisolone group, and joint space narrowing was retarded, though to a lesser extent than erosion.

Patients in the prednisolone group also had significantly fewer newly eroded joints after 2 years, as well as improved physical functioning and significantly higher rates of disease remission (51% vs. 39% in the no-prednisolone group at 1 year, and 56% vs. 33% at 2 years), reported Björn Svensson, M.D., Ph.D., of the University of Lund (Sweden), and his associates (Arthritis Rheum. 2005:52;3360–70).

Investigators in the multicountry study used two scoring systems—the Ratingen score and the modified Sharp/van der Heijde score—to assess radiographs taken at 6 months, 1 year, and 2 years after the start of treatment.

Their results were similar: Increases in the Ratingen score, the Sharp score for erosion, and the total Sharp score were significantly less at each point in time in patients taking prednisolone than in patients taking placebo. Changes in the score for joint space narrowing were significantly different only at 6 months.

In addition, clinical and functional outcomes, as well as rates of disease remission, tended to be better—though not to the level of statistical significance—in the prednisolone group, reported Siegfried Wassenberg, M.D., of Evangelisches Fachkrankenhaus Ratingen (Germany), and his associates (Arthritis Rheum. 2005:52;3371–80).

Some side effects such as weight gain (four patients), hypertension (six), Cushing's syndrome (five), and glaucoma (three) were reported only among patients taking prednisolone.

In the Swedish study, the frequency of adverse events was small, investigators said. And in both studies, prednisolone had little or no impact on bone loss.

“It remains to be seen whether dosages lower than 5 mg provide the same benefit with even fewer side effects and whether the same effect can be produced in patients with more advanced disease,” Dr. Wassenberg and associates said.

Temporomandibular joint arthritis in children with juvenile idiopathic arthritis responds well to intraarticular corticosteroid injection, especially when it is administered early on, reported Bita Arabshahi, M.D., of Children's Hospital of Philadelphia, and colleagues.

Twenty-three children aged 4–16 years who had clinical evidence of temporomandibular arthritis and MRI evidence of temporomandibular joint (TMJ) inflammation underwent CT-guided steroid injection of 1 or more TMJs. Fourteen patients had follow-up MRI studies of the TMJ 6–12 months later.

Ten of 13 patients (77%) who had jaw pain before the injection had no pain after the treatment. Nearly half of all 23 patients had significant improvement in maximal incisal opening (it was below age-matched normal values in all patients), with the most significant improvements seen in patients diagnosed before 5 years of age and in those injected by age 6.

Among the 14 patients who had follow-up MRI, 13 (57%) of the 23 TMJs studied had shown acute joint effusion before injection. Corticosteroid injections resulted in resolution of effusion in more than two-thirds of the acutely affected joints, the investigators reported (Arthritis Rheum. 2005;52:3563–9).

The fact that about one-third of these patients had persistent effusion after injection suggests that “the presence or resolution of pain may not accurately predict the presence of TMJ inflammation,” said the investigators, who collected data retrospectively from medical records and prospectively from patient questionnaires.

The majority of patients were ANA-positive girls who had polyarticular juvenile idiopathic arthritis for a median of 2 years. They were treated with triamcinolone acetonide or triamcinolone hexacetonide.

Temporomandibular joint arthritis in children with juvenile idiopathic arthritis responds well to intraarticular corticosteroid injection, especially when it is administered early on, reported Bita Arabshahi, M.D., of Children's Hospital of Philadelphia, and colleagues.

Twenty-three children aged 4–16 years who had clinical evidence of temporomandibular arthritis and MRI evidence of temporomandibular joint (TMJ) inflammation underwent CT-guided steroid injection of 1 or more TMJs. Fourteen patients had follow-up MRI studies of the TMJ 6–12 months later.

Ten of 13 patients (77%) who had jaw pain before the injection had no pain after the treatment. Nearly half of all 23 patients had significant improvement in maximal incisal opening (it was below age-matched normal values in all patients), with the most significant improvements seen in patients diagnosed before 5 years of age and in those injected by age 6.

Among the 14 patients who had follow-up MRI, 13 (57%) of the 23 TMJs studied had shown acute joint effusion before injection. Corticosteroid injections resulted in resolution of effusion in more than two-thirds of the acutely affected joints, the investigators reported (Arthritis Rheum. 2005;52:3563–9).

The fact that about one-third of these patients had persistent effusion after injection suggests that “the presence or resolution of pain may not accurately predict the presence of TMJ inflammation,” said the investigators, who collected data retrospectively from medical records and prospectively from patient questionnaires.

The majority of patients were ANA-positive girls who had polyarticular juvenile idiopathic arthritis for a median of 2 years. They were treated with triamcinolone acetonide or triamcinolone hexacetonide.

Temporomandibular joint arthritis in children with juvenile idiopathic arthritis responds well to intraarticular corticosteroid injection, especially when it is administered early on, reported Bita Arabshahi, M.D., of Children's Hospital of Philadelphia, and colleagues.

Twenty-three children aged 4–16 years who had clinical evidence of temporomandibular arthritis and MRI evidence of temporomandibular joint (TMJ) inflammation underwent CT-guided steroid injection of 1 or more TMJs. Fourteen patients had follow-up MRI studies of the TMJ 6–12 months later.

Ten of 13 patients (77%) who had jaw pain before the injection had no pain after the treatment. Nearly half of all 23 patients had significant improvement in maximal incisal opening (it was below age-matched normal values in all patients), with the most significant improvements seen in patients diagnosed before 5 years of age and in those injected by age 6.

Among the 14 patients who had follow-up MRI, 13 (57%) of the 23 TMJs studied had shown acute joint effusion before injection. Corticosteroid injections resulted in resolution of effusion in more than two-thirds of the acutely affected joints, the investigators reported (Arthritis Rheum. 2005;52:3563–9).

The fact that about one-third of these patients had persistent effusion after injection suggests that “the presence or resolution of pain may not accurately predict the presence of TMJ inflammation,” said the investigators, who collected data retrospectively from medical records and prospectively from patient questionnaires.

The majority of patients were ANA-positive girls who had polyarticular juvenile idiopathic arthritis for a median of 2 years. They were treated with triamcinolone acetonide or triamcinolone hexacetonide.

GAITHERSBURG, MD. — Tamiflu appears to have played “no role” in the deaths of 12 children in Japan and in 32 reported cases of neuropsychiatric events, 31 of which also occurred in Japan, in children who received the drug after a diagnosis of influenza, the Food and Drug Administration's Pediatric Advisory Committee told the FDA and a swarm of reporters.

The panel recommended, however, that new information be added to the Tamiflu label about the possibility of serious skin reactions.

And it requested that the FDA present the committee with a “preliminary report” of findings from continued monitoring of adverse events as soon as more data are available, “even if it's only after one more flu season.”

Tamiflu, or oseltamivir, was one of eight drugs reviewed as part of a mandated 1-year postpediatric exclusivity review of adverse events.

The Best Pharmaceuticals for Children Act requires the FDA's Office of Pediatric Therapeutics to review adverse events reports received during the year after a drug is granted pediatric exclusivity, and to then refer these reports to the Pediatrics Advisory Committee for its review and recommendations.

The report on Tamiflu took on added significance because FDA officials had—independent of the exclusivity review—identified and begun investigating Japanese case reports of death and neuropsychiatric events as a result of a new monitoring system that was put in place during last year's influenza season.

News of pandemic flu preparations and reports that Tamiflu is being made available for pandemic stockpiling also fueled the interest. The FDA, in material made public before the committee meeting, said that “a better understanding of Tamiflu safety in children will be useful should a pandemic occur.”

Tamiflu was first approved in 1999 for the treatment of influenza in adults. Approval of the Tamiflu oral suspension for treatment in children aged 1 year and up followed in 2000, as did approval for prophylaxis for adults and children aged 13 and up. An application for approval for prophylaxis in children aged 1–12 years is pending.

During the period of time covered by its postexclusivity review—from March 2004 to April 2005—there were 75 adverse event reports concerning children up to 16 years of age. The majority—69 of the reports—were from Japan, 5 were from the United States, and 1 was from Canada.

Eight of the reports, all from Japan, were of deaths. Of the 67 nonfatal reports, 32 were classified as CNS reports such as hallucinations, convulsions, delirium, and abnormal behavior; 12 were deemed skin/hypersensitivity reports, and 23 covered gastrointestinal and other events.

Since the time of approval, there have been 190 reports of serious adverse events in children up to age 16 years (28 of them in the United States), and 12 of them deaths in Japan.

Some of the reported deaths involved children who died suddenly within 1–2 days of starting treatment; other deaths occurred later. Some of the children were reported to be previously healthy, and others had asthma or other medical problems. Brain and pulmonary edema were reported in some cases, encephalopathy in others. One report says that a 14-year-old boy “took his own life” after taking Tamiflu, said Melissa Truffa, a registered pharmacist with the FDA's division of drug risk evaluation in Rockville, Md.

In general, many of the cases involve comorbidities and confounding factors, and the majority have limited or missing data. Combined with the fact that neurologic complications are not uncommon during influenza viral infections, “it's difficult to establish a direct casual relationship between the use of oseltamivir and the reported deaths,” Ms. Truffa told the committee.

Influenza-associated encephalopathy and neuropsychiatric events have been a concern in Japan for over a decade, and national surveillance is strong. The Japanese national health service also facilitates rapid diagnosis and early treatment of influenza, said Linda Lewis, M.D., of the FDA's division of antiviral products in Rockville.

This, said panel member Janet Englund, M.D., stands in stark contrast to the United States. “We are not good at diagnosing influenza. … We absolutely underdiagnose it,” said Dr. Englund, of Children's Hospital and Regional Medical Center in Seattle. “And I know that in our region, there have been shortages [of Tamiflu]. … It's just not used that much.”

According to the drug's manufacturer, Hoffman-La Roche, since 2001 there have been 24.5 million prescriptions in Japan, 11.6 million of them for children. In the United States, there have been 6.5 million prescriptions—approximately 872,000 of them for children.

According to Ms. Truffa, while the overall number of Tamiflu prescriptions has risen in the United States in the past 2 years, the percentage of total prescriptions that are written for children has declined from 40% 3 years ago to 25% last year.

The reports of death and neuropsychiatric adverse events from Japan most likely reflect greater use of the drug and more reporting of influenza-associated adverse events; they may partly reflect unknown pathophysiologic differences, Dr. Lewis said. Dosing, she noted, is similar in the United States and Japan.

It is possible, she said, “that similar events might be reported in the United States if Tamiflu use increases substantially or, especially, if awareness of neuropsychiatric complications [of influenza] increases.”

Of the 12 reports of skin hypersensitivity reactions that were filed during Tamiflu's postexclusivity period, four cases were “notable cases” that “could have possibly been caused by Tamiflu,” Ms. Truffa told the committee.

These and other cases identified from a review of adverse events from the 2004–2005 flu season prompted the FDA to further investigate all reports of serious skin and hypersensitivity reactions. Officials found 16 reports of serious skin reactions, 18 reports of anaphylaxis, and 1 associated death in children from the time of Tamiflu's approval to April 2005.

Additional data are currently under review, and the FDA will propose additional information in the Tamiflu labeling regarding serious skin reactions, FDA officials told the committee.

Current labeling lists dermatitis, rash, swelling of the face or tongue, and toxic epidermal necrolysis as observed and adverse reactions of the drug.

A reanalysis of data from the pediatric clinical trials of Tamiflu, as well as a literature review, failed to identify any differences in both skin and neuropsychiatric adverse events between children with influenza who received Tamiflu and those who received placebo or no treatment, Dr. Lewis said.

FDA Panel Clears Two Other Drugs

Sumatriptan and fluconazole were among the drugs that received a green light for routine adverse event monitoring by the Food and Drug Administration's Pediatric Advisory Committee.

The committee gave the thumbs-up after the FDA reported that there were no new unlabeled safety concerns identified in the pediatric adverse events that were reported during the drugs' 1-year postexclusivity periods.

There were six unduplicated pediatric adverse events reports associated with the sumatriptan (Imitrex) nasal spray for treatment of migraine, and none of the reports were serious or life threatening, reported Susan McCune, M.D., a medical officer in the FDA's division of pediatric drug development, Rockville, Md.

For the antifungal fluconazole (Diflucan), there were 19 unduplicated reports of adverse events in children, including four deaths. Most reports were “highly confounded” by underlying illness and concomitant medications, and “although serious adverse events occurred, most were expected or addressed in the drug's labeling,” said Larry Grylack, M.D., also of the FDA's division of pediatric drug development.

The 15 nonfatal adverse events reported in patients taking Diflucan involved the following: congenital anomalies in three reports, cardiac events in three, metabolic problems in two, hepatic problems in two, nonfatal fungemia in two, dosing errors in two, and hypersensitivity in one.

Dr. Grylack also reported that there were no new safety concerns identified for the NSAID rofecoxib (Vioxx). During a 7-month exclusivity period, there were 19 pediatric reports, including three foreign deaths, associated with the drug. No further monitoring is necessary, he said, since the drug has been withdrawn from the market.

The other drugs reviewed that also had no new safety concerns were antineoplastic agent irinotecan (Camptosar), antineoplastic agent carboplatin (Paraplatin), platelet-reducing agent anagrelide (Agrylin), and hematinic agent sodium ferric gluconate complex (Ferrlecit).

GAITHERSBURG, MD. — Tamiflu appears to have played “no role” in the deaths of 12 children in Japan and in 32 reported cases of neuropsychiatric events, 31 of which also occurred in Japan, in children who received the drug after a diagnosis of influenza, the Food and Drug Administration's Pediatric Advisory Committee told the FDA and a swarm of reporters.

The panel recommended, however, that new information be added to the Tamiflu label about the possibility of serious skin reactions.

And it requested that the FDA present the committee with a “preliminary report” of findings from continued monitoring of adverse events as soon as more data are available, “even if it's only after one more flu season.”

Tamiflu, or oseltamivir, was one of eight drugs reviewed as part of a mandated 1-year postpediatric exclusivity review of adverse events.

The Best Pharmaceuticals for Children Act requires the FDA's Office of Pediatric Therapeutics to review adverse events reports received during the year after a drug is granted pediatric exclusivity, and to then refer these reports to the Pediatrics Advisory Committee for its review and recommendations.

The report on Tamiflu took on added significance because FDA officials had—independent of the exclusivity review—identified and begun investigating Japanese case reports of death and neuropsychiatric events as a result of a new monitoring system that was put in place during last year's influenza season.

News of pandemic flu preparations and reports that Tamiflu is being made available for pandemic stockpiling also fueled the interest. The FDA, in material made public before the committee meeting, said that “a better understanding of Tamiflu safety in children will be useful should a pandemic occur.”

Tamiflu was first approved in 1999 for the treatment of influenza in adults. Approval of the Tamiflu oral suspension for treatment in children aged 1 year and up followed in 2000, as did approval for prophylaxis for adults and children aged 13 and up. An application for approval for prophylaxis in children aged 1–12 years is pending.

During the period of time covered by its postexclusivity review—from March 2004 to April 2005—there were 75 adverse event reports concerning children up to 16 years of age. The majority—69 of the reports—were from Japan, 5 were from the United States, and 1 was from Canada.

Eight of the reports, all from Japan, were of deaths. Of the 67 nonfatal reports, 32 were classified as CNS reports such as hallucinations, convulsions, delirium, and abnormal behavior; 12 were deemed skin/hypersensitivity reports, and 23 covered gastrointestinal and other events.

Since the time of approval, there have been 190 reports of serious adverse events in children up to age 16 years (28 of them in the United States), and 12 of them deaths in Japan.

Some of the reported deaths involved children who died suddenly within 1–2 days of starting treatment; other deaths occurred later. Some of the children were reported to be previously healthy, and others had asthma or other medical problems. Brain and pulmonary edema were reported in some cases, encephalopathy in others. One report says that a 14-year-old boy “took his own life” after taking Tamiflu, said Melissa Truffa, a registered pharmacist with the FDA's division of drug risk evaluation in Rockville, Md.

In general, many of the cases involve comorbidities and confounding factors, and the majority have limited or missing data. Combined with the fact that neurologic complications are not uncommon during influenza viral infections, “it's difficult to establish a direct casual relationship between the use of oseltamivir and the reported deaths,” Ms. Truffa told the committee.

Influenza-associated encephalopathy and neuropsychiatric events have been a concern in Japan for over a decade, and national surveillance is strong. The Japanese national health service also facilitates rapid diagnosis and early treatment of influenza, said Linda Lewis, M.D., of the FDA's division of antiviral products in Rockville.

This, said panel member Janet Englund, M.D., stands in stark contrast to the United States. “We are not good at diagnosing influenza. … We absolutely underdiagnose it,” said Dr. Englund, of Children's Hospital and Regional Medical Center in Seattle. “And I know that in our region, there have been shortages [of Tamiflu]. … It's just not used that much.”

According to the drug's manufacturer, Hoffman-La Roche, since 2001 there have been 24.5 million prescriptions in Japan, 11.6 million of them for children. In the United States, there have been 6.5 million prescriptions—approximately 872,000 of them for children.

According to Ms. Truffa, while the overall number of Tamiflu prescriptions has risen in the United States in the past 2 years, the percentage of total prescriptions that are written for children has declined from 40% 3 years ago to 25% last year.

The reports of death and neuropsychiatric adverse events from Japan most likely reflect greater use of the drug and more reporting of influenza-associated adverse events; they may partly reflect unknown pathophysiologic differences, Dr. Lewis said. Dosing, she noted, is similar in the United States and Japan.

It is possible, she said, “that similar events might be reported in the United States if Tamiflu use increases substantially or, especially, if awareness of neuropsychiatric complications [of influenza] increases.”

Of the 12 reports of skin hypersensitivity reactions that were filed during Tamiflu's postexclusivity period, four cases were “notable cases” that “could have possibly been caused by Tamiflu,” Ms. Truffa told the committee.

These and other cases identified from a review of adverse events from the 2004–2005 flu season prompted the FDA to further investigate all reports of serious skin and hypersensitivity reactions. Officials found 16 reports of serious skin reactions, 18 reports of anaphylaxis, and 1 associated death in children from the time of Tamiflu's approval to April 2005.

Additional data are currently under review, and the FDA will propose additional information in the Tamiflu labeling regarding serious skin reactions, FDA officials told the committee.

Current labeling lists dermatitis, rash, swelling of the face or tongue, and toxic epidermal necrolysis as observed and adverse reactions of the drug.

A reanalysis of data from the pediatric clinical trials of Tamiflu, as well as a literature review, failed to identify any differences in both skin and neuropsychiatric adverse events between children with influenza who received Tamiflu and those who received placebo or no treatment, Dr. Lewis said.

FDA Panel Clears Two Other Drugs

Sumatriptan and fluconazole were among the drugs that received a green light for routine adverse event monitoring by the Food and Drug Administration's Pediatric Advisory Committee.

The committee gave the thumbs-up after the FDA reported that there were no new unlabeled safety concerns identified in the pediatric adverse events that were reported during the drugs' 1-year postexclusivity periods.

There were six unduplicated pediatric adverse events reports associated with the sumatriptan (Imitrex) nasal spray for treatment of migraine, and none of the reports were serious or life threatening, reported Susan McCune, M.D., a medical officer in the FDA's division of pediatric drug development, Rockville, Md.

For the antifungal fluconazole (Diflucan), there were 19 unduplicated reports of adverse events in children, including four deaths. Most reports were “highly confounded” by underlying illness and concomitant medications, and “although serious adverse events occurred, most were expected or addressed in the drug's labeling,” said Larry Grylack, M.D., also of the FDA's division of pediatric drug development.

The 15 nonfatal adverse events reported in patients taking Diflucan involved the following: congenital anomalies in three reports, cardiac events in three, metabolic problems in two, hepatic problems in two, nonfatal fungemia in two, dosing errors in two, and hypersensitivity in one.

Dr. Grylack also reported that there were no new safety concerns identified for the NSAID rofecoxib (Vioxx). During a 7-month exclusivity period, there were 19 pediatric reports, including three foreign deaths, associated with the drug. No further monitoring is necessary, he said, since the drug has been withdrawn from the market.

The other drugs reviewed that also had no new safety concerns were antineoplastic agent irinotecan (Camptosar), antineoplastic agent carboplatin (Paraplatin), platelet-reducing agent anagrelide (Agrylin), and hematinic agent sodium ferric gluconate complex (Ferrlecit).

GAITHERSBURG, MD. — Tamiflu appears to have played “no role” in the deaths of 12 children in Japan and in 32 reported cases of neuropsychiatric events, 31 of which also occurred in Japan, in children who received the drug after a diagnosis of influenza, the Food and Drug Administration's Pediatric Advisory Committee told the FDA and a swarm of reporters.

The panel recommended, however, that new information be added to the Tamiflu label about the possibility of serious skin reactions.

And it requested that the FDA present the committee with a “preliminary report” of findings from continued monitoring of adverse events as soon as more data are available, “even if it's only after one more flu season.”

Tamiflu, or oseltamivir, was one of eight drugs reviewed as part of a mandated 1-year postpediatric exclusivity review of adverse events.

The Best Pharmaceuticals for Children Act requires the FDA's Office of Pediatric Therapeutics to review adverse events reports received during the year after a drug is granted pediatric exclusivity, and to then refer these reports to the Pediatrics Advisory Committee for its review and recommendations.

The report on Tamiflu took on added significance because FDA officials had—independent of the exclusivity review—identified and begun investigating Japanese case reports of death and neuropsychiatric events as a result of a new monitoring system that was put in place during last year's influenza season.

News of pandemic flu preparations and reports that Tamiflu is being made available for pandemic stockpiling also fueled the interest. The FDA, in material made public before the committee meeting, said that “a better understanding of Tamiflu safety in children will be useful should a pandemic occur.”

Tamiflu was first approved in 1999 for the treatment of influenza in adults. Approval of the Tamiflu oral suspension for treatment in children aged 1 year and up followed in 2000, as did approval for prophylaxis for adults and children aged 13 and up. An application for approval for prophylaxis in children aged 1–12 years is pending.

During the period of time covered by its postexclusivity review—from March 2004 to April 2005—there were 75 adverse event reports concerning children up to 16 years of age. The majority—69 of the reports—were from Japan, 5 were from the United States, and 1 was from Canada.

Eight of the reports, all from Japan, were of deaths. Of the 67 nonfatal reports, 32 were classified as CNS reports such as hallucinations, convulsions, delirium, and abnormal behavior; 12 were deemed skin/hypersensitivity reports, and 23 covered gastrointestinal and other events.

Since the time of approval, there have been 190 reports of serious adverse events in children up to age 16 years (28 of them in the United States), and 12 of them deaths in Japan.

Some of the reported deaths involved children who died suddenly within 1–2 days of starting treatment; other deaths occurred later. Some of the children were reported to be previously healthy, and others had asthma or other medical problems. Brain and pulmonary edema were reported in some cases, encephalopathy in others. One report says that a 14-year-old boy “took his own life” after taking Tamiflu, said Melissa Truffa, a registered pharmacist with the FDA's division of drug risk evaluation in Rockville, Md.

In general, many of the cases involve comorbidities and confounding factors, and the majority have limited or missing data. Combined with the fact that neurologic complications are not uncommon during influenza viral infections, “it's difficult to establish a direct casual relationship between the use of oseltamivir and the reported deaths,” Ms. Truffa told the committee.

Influenza-associated encephalopathy and neuropsychiatric events have been a concern in Japan for over a decade, and national surveillance is strong. The Japanese national health service also facilitates rapid diagnosis and early treatment of influenza, said Linda Lewis, M.D., of the FDA's division of antiviral products in Rockville.

This, said panel member Janet Englund, M.D., stands in stark contrast to the United States. “We are not good at diagnosing influenza. … We absolutely underdiagnose it,” said Dr. Englund, of Children's Hospital and Regional Medical Center in Seattle. “And I know that in our region, there have been shortages [of Tamiflu]. … It's just not used that much.”

According to the drug's manufacturer, Hoffman-La Roche, since 2001 there have been 24.5 million prescriptions in Japan, 11.6 million of them for children. In the United States, there have been 6.5 million prescriptions—approximately 872,000 of them for children.

According to Ms. Truffa, while the overall number of Tamiflu prescriptions has risen in the United States in the past 2 years, the percentage of total prescriptions that are written for children has declined from 40% 3 years ago to 25% last year.

The reports of death and neuropsychiatric adverse events from Japan most likely reflect greater use of the drug and more reporting of influenza-associated adverse events; they may partly reflect unknown pathophysiologic differences, Dr. Lewis said. Dosing, she noted, is similar in the United States and Japan.

It is possible, she said, “that similar events might be reported in the United States if Tamiflu use increases substantially or, especially, if awareness of neuropsychiatric complications [of influenza] increases.”

Of the 12 reports of skin hypersensitivity reactions that were filed during Tamiflu's postexclusivity period, four cases were “notable cases” that “could have possibly been caused by Tamiflu,” Ms. Truffa told the committee.

These and other cases identified from a review of adverse events from the 2004–2005 flu season prompted the FDA to further investigate all reports of serious skin and hypersensitivity reactions. Officials found 16 reports of serious skin reactions, 18 reports of anaphylaxis, and 1 associated death in children from the time of Tamiflu's approval to April 2005.

Additional data are currently under review, and the FDA will propose additional information in the Tamiflu labeling regarding serious skin reactions, FDA officials told the committee.

Current labeling lists dermatitis, rash, swelling of the face or tongue, and toxic epidermal necrolysis as observed and adverse reactions of the drug.

A reanalysis of data from the pediatric clinical trials of Tamiflu, as well as a literature review, failed to identify any differences in both skin and neuropsychiatric adverse events between children with influenza who received Tamiflu and those who received placebo or no treatment, Dr. Lewis said.

FDA Panel Clears Two Other Drugs

Sumatriptan and fluconazole were among the drugs that received a green light for routine adverse event monitoring by the Food and Drug Administration's Pediatric Advisory Committee.

The committee gave the thumbs-up after the FDA reported that there were no new unlabeled safety concerns identified in the pediatric adverse events that were reported during the drugs' 1-year postexclusivity periods.

There were six unduplicated pediatric adverse events reports associated with the sumatriptan (Imitrex) nasal spray for treatment of migraine, and none of the reports were serious or life threatening, reported Susan McCune, M.D., a medical officer in the FDA's division of pediatric drug development, Rockville, Md.

For the antifungal fluconazole (Diflucan), there were 19 unduplicated reports of adverse events in children, including four deaths. Most reports were “highly confounded” by underlying illness and concomitant medications, and “although serious adverse events occurred, most were expected or addressed in the drug's labeling,” said Larry Grylack, M.D., also of the FDA's division of pediatric drug development.

The 15 nonfatal adverse events reported in patients taking Diflucan involved the following: congenital anomalies in three reports, cardiac events in three, metabolic problems in two, hepatic problems in two, nonfatal fungemia in two, dosing errors in two, and hypersensitivity in one.

Dr. Grylack also reported that there were no new safety concerns identified for the NSAID rofecoxib (Vioxx). During a 7-month exclusivity period, there were 19 pediatric reports, including three foreign deaths, associated with the drug. No further monitoring is necessary, he said, since the drug has been withdrawn from the market.

The other drugs reviewed that also had no new safety concerns were antineoplastic agent irinotecan (Camptosar), antineoplastic agent carboplatin (Paraplatin), platelet-reducing agent anagrelide (Agrylin), and hematinic agent sodium ferric gluconate complex (Ferrlecit).

WASHINGTON — Screening for parental depression at well-child visits is feasible and parents are receptive to the idea, Ardis L. Olson, M.D., reported at the annual meeting of the Pediatric Academic Societies.

A brief, validated questionnaire, the two-question version of the Patient Health Questionnaire depression module (PHQ-2), was completed by almost 8,000 parents in about half of the well-child visits conducted in six small- to medium-sized practices during a 6-month period.

The practices had been prepared for screening with provider and parent education, said Dr. Olson of Dartmouth-Hitchcock Medical Center in Lebanon, N.H.

Rates of positive PHQ-2 screens were similar for both mothers and fathers (about 5% for each). Pediatricians were more likely to refer mothers who screened positively (39%) than fathers who screened positively (21%), however, to primary care or mental health providers. They were equally as likely to refer mothers and fathers (26%) to a telephone support referral service called the Parent Support Line.

One-quarter of the parents accepted the services of the Parent Support Line when they were offered a call from the service, while fewer than 1% accessed the service when given a Web site or 800 number—a finding that indicates that follow-up must be proactive, Dr. Olson said.

WASHINGTON — Screening for parental depression at well-child visits is feasible and parents are receptive to the idea, Ardis L. Olson, M.D., reported at the annual meeting of the Pediatric Academic Societies.

A brief, validated questionnaire, the two-question version of the Patient Health Questionnaire depression module (PHQ-2), was completed by almost 8,000 parents in about half of the well-child visits conducted in six small- to medium-sized practices during a 6-month period.

The practices had been prepared for screening with provider and parent education, said Dr. Olson of Dartmouth-Hitchcock Medical Center in Lebanon, N.H.

Rates of positive PHQ-2 screens were similar for both mothers and fathers (about 5% for each). Pediatricians were more likely to refer mothers who screened positively (39%) than fathers who screened positively (21%), however, to primary care or mental health providers. They were equally as likely to refer mothers and fathers (26%) to a telephone support referral service called the Parent Support Line.

One-quarter of the parents accepted the services of the Parent Support Line when they were offered a call from the service, while fewer than 1% accessed the service when given a Web site or 800 number—a finding that indicates that follow-up must be proactive, Dr. Olson said.

WASHINGTON — Screening for parental depression at well-child visits is feasible and parents are receptive to the idea, Ardis L. Olson, M.D., reported at the annual meeting of the Pediatric Academic Societies.

A brief, validated questionnaire, the two-question version of the Patient Health Questionnaire depression module (PHQ-2), was completed by almost 8,000 parents in about half of the well-child visits conducted in six small- to medium-sized practices during a 6-month period.

The practices had been prepared for screening with provider and parent education, said Dr. Olson of Dartmouth-Hitchcock Medical Center in Lebanon, N.H.

Rates of positive PHQ-2 screens were similar for both mothers and fathers (about 5% for each). Pediatricians were more likely to refer mothers who screened positively (39%) than fathers who screened positively (21%), however, to primary care or mental health providers. They were equally as likely to refer mothers and fathers (26%) to a telephone support referral service called the Parent Support Line.

One-quarter of the parents accepted the services of the Parent Support Line when they were offered a call from the service, while fewer than 1% accessed the service when given a Web site or 800 number—a finding that indicates that follow-up must be proactive, Dr. Olson said.