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  Vol. 162 No. 3, February 11, 2002 TABLE OF CONTENTS
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Periconceptional Exposure to Efavirenz and Neural Tube Defects

Arch Intern Med. 2002;162:355.

Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

Efavirenz is the most potent non-nucleoside reverse transcriptase inhibitor given orally to treat human immunodeficiency virus infection. The standard dosage is 600 mg once daily, taken in combination therapy.

This drug is contraindicated in the periconceptional period and during pregnancy, as suggested by animal teratology studies. In 3 (15%) of 20 pregnant cynomolgus monkeys, exposed at therapeutic doses similar to those used for humans, efavirenz produced the following malformations: anencephaly with unilateral anophthalmia (1 case), microphthalmia (1 case), and cleft palate (1 case).1-2 The manufacturer (DuPont Pharmaceuticals Company, Wilmington, Del) recommends that women who take efavirenz avoid pregnancy, and the drug is classified by the US Food and Drug Administration in pregnancy category C.1-2

To our knowledge, no epidemiological studies of congenital anomalies in newborns of women treated with efavirenz during pregnancy have been reported.

We describe herein 3 women who conceived during therapy with efavirenz, including one whose pregnancy . . . [Full Text of this Article]

Report of Cases

Case 1

Case 2

Case 3


Comment
Corresponding author and reprints: Marco De Santis, MD, Department of Obstetrics and Gynecology, Catholic University of Sacred Heart, Largo A Gemelli 8, 00168 Rome, Italy (e-mail: marco.desantis15@tin.it).



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