Pregnancy and powerful acne medicines like Accutane don’t mix. That’s the message pregnancy counselors with the Organization of Teratology Information Services are trying to convey to pregnant women, health care providers, pharmaceutical companies, and decision-makers in the federal government.
OTIS, a nonprofit organization that conducts research and provides education on the effects of drugs and chemicals on the human fetus, presented the Food and Drug Administration with preliminary findings from a survey of women in the U.S. and Canada who used Accutane at the time they became pregnant. OTIS told FDA members that only the most stringent restrictions could prevent more Accutane-exposed pregnancies.
“Having nice-looking skin is not worth the risk of having an abnormal baby or child,” stressed Debbie Banner, a Virginia mother whose son was born with brain damage as a result of Accutane exposure during her pregnancy.
The FDA approved Accutane in 1982 as a prescription medication for severe or cystic acne. Although the drug’s label warned it was not to be taken by pregnant women, exposed pregnancies continued. It was found that Accutane was a teratogen, meaning it can cause brain and heart defects, mental retardation, and other abnormalities, OTIS said in a prepared statement issued on Monday.
By 1999, it was reported that nearly three out of every 1,000 American women aged 15-44 were taking Accutane. The more recent introduction of additional forms of isotretinoin (Amnesteem(r), Claravis(r), and Sotret(r)) may further increase usage, OTIS said.
In late February, the FDA held hearings to consider imposing stricter regulations on Accutane, which has been shown to cause birth and developmental defects.
The FDA has agreed to review recommendations by an advisory panel for manufacturers to establish a national registry system in which all patients using any form of isotretinoin would be required to enroll. For female patients, this would mean they could no longer obtain a prescription without a negative pregnancy test and written instructions by their doctor to use two forms of birth control while on the drug.
“We encourage the manufacturers of isotretinoin to implement a mandatory, nationwide registry, including required contraception counseling by trained professionals,” said Dr. John C. Carey of the University of Utah School of Medicine and Medical Director of Utah’s Pregnancy Risk Line.
(via PR Newswire)
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