Pregnancy Rates Among Accutane Users Remain Steady Despite Restriction on Drug That Causes Birth Defects

Disturbing news from USA Today about pregnancies in women using Accutane, an acne drug known to cause birth defects.

A year ago, the FDA tightened restrictions on Accutane and its generic counterpart isotretinoin, requiring patients who use the drug to enroll in the iPledge program that is supposed to help prevent pregnancies in Accutane users.

More than 120 women became pregnant on Accutane in the past year, according to data from a national registry. The number of pregnancies among Accutane patients is about the same as it was before the FDA began requiring users, doctors and pharmacists to enroll in the program. Women who are prescribed Accutane must use birth control and pass pregnancy tests before they get a prescription refill.

Accutane, which is used to treat cystic acne, is known to cause severe birth defects. Babies whose mothers took the drug while pregnant can be born with “severe brain and heart defects, mental retardation and other abnormalities, even if the mother took only a small dose for a short period. That’s a risk for 30 days after stopping the drug, too.”

The March of Dimes, an organization I support for very personal reasons — I have a son who was born prematurely — lobbied for tighter restrictions on Accutane because of the scientifically proven connection between Accutane and birth defects.

But if these newest statistics are any indication, more needs to be done to restrict this dangerous drug Accutane, which has also been linked to heart and liver disease in adult patients.

Obviously, more needs to be done to make sure that women who have been prescribed Accutane or the generic don’t become pregnant. But the bigger question is this: Should a drug this dangerous even be on the market?