terça-feira, abril 19, 2005

Stocrin contra-indicado para mulheres grávidas

Important Change in SUSTIVA (efavirenz) Package Insert —Change from Pregnancy Category C to D

Dear Health Care Provider,
Bristol-Myers Squibb Company would like to make clinicians who are caring for HIV-1-infected patients aware of important new information in the SUSTIVA Package Insert regarding pregnancy. The pregnancy category for SUSTIVA has been changed from Category C (Risk of Fetal Harm Cannot Be Ruled Out) to Category D (Positive Evidence of Fetal Risk). This change is 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.

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