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Efavirenz pregnancy warning.
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1998
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Reproductive HealthGynecologyHigh-risk PregnancyContraceptionDupont MerckReproductive MedicineObstetricsPrenatal CarePublic HealthSexual And Reproductive HealthInfertilityMaternal ComplicationEfavirenz Pregnancy WarningMaternal HealthMaternal-fetal MedicinePrenatal TestingSevere Birth DefectsAbortionPregnancyPregnant WomenMedicineWomen's Health
A study conducted by DuPont Merck, manufacturer of efavirenz (DMP266, Sustiva), found severe birth defects occurred in an estimated one quarter of monkeys born to mothers taking the drug early in gestation. The company believes the abnormalities did not stem from genetic damage, but rather from the drug's effect on initial fetal growth. No pregnant women are included in the trial program, and women should not become pregnant while taking efavirenz. Participants will be required to use additional measures of contraception. DuPont Merck plans to request a category C pregnancy warning from the Food and Drug Administration (FDA) indicating safety in pregnancy is undetermined. The manufacturer also will conduct third trimester vertical transmission testing. Twenty percent of the 2,362 enrollees in the trial program are women.