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Sustiva FDA Alerts

The FDA Alert(s) below may be specifically about Sustiva or relate to a group or class of drugs which include Sustiva (efavirenz).

MedWatch Safety Alerts are distributed by the FDA and published by Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for efavirenz

Sustiva (efavirenz) Capsules and Tablets

Jun 10, 2005

Audience: Infectious disease and other healthcare professionals, consumers

Bristol-Myers Squibb and FDA notified healthcare professionals of revisions to the WARNINGS, PRECAUTIONS/Pregnancy and Information for Patients, and PATIENT INFORMATION sections of the prescribing information for Sustiva (efavirenz), indicated in the treatment of HIV-1 infection. The revisions are a result of four retrospective reports of neural tube defects in infants born to women with first trimester exposure to Sustiva, including three cases of meningomyelocele and one Dandy Walker Syndrome. As Sustiva may cause fetal harm when administered during the first trimester to a pregnant woman, pregnancy should be avoided in women receiving Sustiva. An antiretroviral pregnancy registry has been established to monitor fetal outcomes of pregnant women exposed to Sustiva.

[March, 2005 - Dear Healthcare Professional Letter - Bristol-Myers Squibb]
[February, 2005 - Label - Bristol-Myers Squibb ]

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