An acne medication known to cause severe birth defects is so serious a risk to babies that any woman taking the medication is required to enroll in a program to prevent pregnancy. However, that has not prevented more than 120 women from becoming pregnant anyway, though they were enrolled in the preventative program.
On Wednesday, Accutane and its generic counterparts were due for a review from the Food and Drug Administration in two days time. The FDA gathered its scientific advisers to evaluate the drug’s safety restrictions, reports Associated Press writer Lauran Neergaard.
Newly-released data from the national registry on Monday show that the one-year-old iPledge program, meant to prevent conception, has had little or no effect. The 122 pregnancies reported in the past year are about the same as those numbers in previous years—before the FDA tightened restrictions for the substance.
Now, the question posed to Wednesday’s advisory committee for debate was clear: Is the new program working or not? The answer may seem clear-cut, but FDA deputy drug director Dr. Sandra Kweder said that it’s far more complex than it would appear. “It’s a difficult comparison because until the national registry began, officials weren’t sure if they were learning about all the pregnancies affected by this very risky drug.”
Accutane, chemically known as isotretinoin, is incredibly dangerous for babies in the womb. Fetuses can suffer severe heart and brain defects, mental retardation, and other abnormalities. And Accutane is so potent that even if the woman only took a small dosage for a very short span of time, her unborn child can still be at great risk if she was pregnant while she took the drug. A 30-day period must be allowed between the ceasing of treatments and conception. Those who do not follow the strict rules and requirements of an Accutane prescription plan, which includes birth control and monthly pregnancy tests, can be kicked out of the program.
