FDA warns of birth defect risks from dolutegravir

 

The Food and Drug Administration has issued a Drug Safety Communication alert that serious cases of neural tube birth defects have been reported in babies born to women treated with dolutegravir for human immunodeficiency virus. Reported defects have involved the brain, spine, and spinal cord.

copyright alexskopje/Thinkstock

Evidence of a higher risk of these defects was seen in the preliminary results of an ongoing observational study in Botswana of women treated with the drug from the initiation of pregnancy through early in the first trimester, a critical period in neural tube development. Such birth defects can occur early in pregnancy when the spinal cord, brain, and related structures do not form properly.

To date, in this observational study, there are no reported cases of babies born with neural tube defects to women starting dolutegravir later in pregnancy, according to the FDA. “We are investigating this new safety issue and will update the public when we have more information,” the alert stated.

Dolutegravir is an FDA-approved antiretroviral used to treat HIV. The drug is available as a single ingredient under the brand name Tivicay and as a combination tablet with other HIV medicines under the brand names Juluca and Triumeq.

Medwatch also released an alert for medical practitioners to report adverse events related to this issue.

[email protected]

 

The Food and Drug Administration has issued a Drug Safety Communication alert that serious cases of neural tube birth defects have been reported in babies born to women treated with dolutegravir for human immunodeficiency virus. Reported defects have involved the brain, spine, and spinal cord.

copyright alexskopje/Thinkstock

Evidence of a higher risk of these defects was seen in the preliminary results of an ongoing observational study in Botswana of women treated with the drug from the initiation of pregnancy through early in the first trimester, a critical period in neural tube development. Such birth defects can occur early in pregnancy when the spinal cord, brain, and related structures do not form properly.

To date, in this observational study, there are no reported cases of babies born with neural tube defects to women starting dolutegravir later in pregnancy, according to the FDA. “We are investigating this new safety issue and will update the public when we have more information,” the alert stated.

Dolutegravir is an FDA-approved antiretroviral used to treat HIV. The drug is available as a single ingredient under the brand name Tivicay and as a combination tablet with other HIV medicines under the brand names Juluca and Triumeq.

Medwatch also released an alert for medical practitioners to report adverse events related to this issue.

[email protected]

 

The Food and Drug Administration has issued a Drug Safety Communication alert that serious cases of neural tube birth defects have been reported in babies born to women treated with dolutegravir for human immunodeficiency virus. Reported defects have involved the brain, spine, and spinal cord.

copyright alexskopje/Thinkstock

Evidence of a higher risk of these defects was seen in the preliminary results of an ongoing observational study in Botswana of women treated with the drug from the initiation of pregnancy through early in the first trimester, a critical period in neural tube development. Such birth defects can occur early in pregnancy when the spinal cord, brain, and related structures do not form properly.

To date, in this observational study, there are no reported cases of babies born with neural tube defects to women starting dolutegravir later in pregnancy, according to the FDA. “We are investigating this new safety issue and will update the public when we have more information,” the alert stated.

Dolutegravir is an FDA-approved antiretroviral used to treat HIV. The drug is available as a single ingredient under the brand name Tivicay and as a combination tablet with other HIV medicines under the brand names Juluca and Triumeq.

Medwatch also released an alert for medical practitioners to report adverse events related to this issue.

[email protected]