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Health Care Professionals Alerted to Efavirenz Use in Pregnant Women
June 15, 2005
June 13, 2005 -- 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.
To view the Dear Health Care Professional letter, click here.
Source: The Food and Drug Administration
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