Anti-acne drug that causes serious birth defects must be more strictly regulated, March of Dimes says

September 17, 2000

GAITHERSBURG, MD, SEPT. 18, 2000 -- Warning that too many pregnant women are being exposed to the anti-acne drug Accutane (isotretinoin), which can cause severe birth defects and miscarriage, the March of Dimes said today that the drug must be regulated by the same rigorous system currently used for thalidomide. The March of Dimes' comments were made at a Food and Drug Administration meeting here.

"The existing pregnancy prevention system for Accutane is inadequate," said Nancy S. Green, M.D., associate medical director of the March of Dimes. "Too many prescriptions for the drug are being written, and too many pregnant women are being exposed to it. A highly effective regulatory system now exists for thalidomide, another powerful teratogen (birth defect-causing agent), and there's no good reason why it should not be used for Accutane as well. Even a single pregnancy exposed to Accutane is one too many, given all we know about the severe harm this drug can do to fetuses."

Dr. Green noted that there is an extremely high risk of fetal malformations if a woman becomes pregnant while taking Accutane, even if she is taking a small amount of the drug for a short period. Birth defects associated with Accutane include: hydrocephalus (enlargement of the fluid-filled spaces in the brain); microcephaly (small head and brain); mental retardation; heart defects; ear and eye abnormalities; cleft lip and palate; and other facial abnormalities.

"Accutane and the other retinoids can cause these birth defects in the early weeks after conception, a time when a woman often doesn't know she's pregnant," Dr. Green said.
Accutane is a member of a family of drugs called retinoids, which are related to vitamin A. Among the other retinoids are Soriatane (actiretin), Tegison (etretinate), and Vesanoid (retinoin).

Dr. Green pointed out that a 1999 study by the Slone Epidemiology Unit at Boston University, which regularly tracks Accutane usage, found that 3 out of every 1,000 women taking Accutane become pregnant. She also noted a January 2000 article published in Morbidity and Mortality Weekly Report, which contained reports of women who took Accutane while pregnant ("Accutane-Exposed Pregnancies -- California," E.J. Lammer, M.D., et al., MMWR, vol. 49, issue 2, Jan. 21, 2000).

The March of Dimes has posted an alert about Accutane use in pregnancy on its Web site at

The March of Dimes is a national voluntary health agency whose mission is to improve the health of babies by preventing birth defects and infant mortality. Founded in 1938, the March of Dimes funds programs of research, community services, education, and advocacy to save babies. For more information, visit the March of Dimes Web site or call toll-free 1-888-MODIMES.

March of Dimes Foundation

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