Pharmacy Services
Efavirenz (Sustiva) - Pregnancy Risk has Changed to Category D (positive evidence of fetal risk)
June 13, 2005
Women receiving efavirenz (Sustiva) should avoid pregnancy. Four case reports of neural tube defects in infants born to women who received efavirenz in their first trimester are available. Bristol-Myers Squibb has revised their prescribing information sheet to reflect these additional warnings.
More information on the efavirenz warning and labeling changes can be found at the following links:
- MedWatch Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152629.htm - Dear Healthcare Professional Letter:
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM164871.pdf
Updated
June 13, 2005; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
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