Sept. 15, 2000 (Washington) -- After almost two decades on the U.S. market, a popular treatment for severe acne may face new marketing restrictions, aimed at preventing pregnant women from using the medication and at keeping women who are on the drug from getting pregnant.
At public meetings scheduled for Monday and Tuesday, FDA officials will ask a committee of experts to review safety information about and recommend possible new restrictions for Hoffmann-La Roche's Accutane, a treatment for severe acne. The drug, which is given to patients who have failed to respond to other anti-acne measures, is known to cause abnormalities in fetuses.
Recent studies have reported that women on Accutane continue to get pregnant, although Hoffmann-La Roche implemented a Pregnancy Prevention Program in 1989 aimed at drawing attention to the potential for birth defects. As part of the program, all women who are prescribed the drug are asked to sign a disclosure form saying they're aware of the risks.
In January, the latest of these studies concluded that women appear to be ignoring these warnings, even when they know about the potential consequences. In that study, a CDC-sponsored survey of 14 women who got pregnant while on the drug, eight of the women reported having sexual intercourse without contraception at least once, and 13 said that they did not use two forms of contraception, as recommended on the drug's label. All 14 women admitted knowing about the effects of the drug on a fetus.
"The study shows that some of these pregnancies were preventable and that is of concern," Peggy Honein, PhD, MPH, the study author, told WebMD at the time.
The results can be devastating, Honein added, noting that four of the 14 pregnancies ended in miscarriage and that one infant was born with major malformations. Four live births with no major malformations were reported; the remainder of the women had abortions.
Still, Hoffmann-La Roche stands by its pregnancy-prevention program, company spokesperson Melissa Ziriakus tells WebMD. "We feel that it is a very effective program," she says.
In documents supplied to the FDA committee members, Hoffmann-La Roche executives say that data from one large HMO database, combined with that from a recent large clinical trial, suggest that the program has reduced the rate of pregnancy among women on the medication. It cut the pregnancy rate by 80 to 90 percent from what would otherwise be expected in this population, the company says.
And since 1991, the use of Accutane has increased without a significant effect on pregnancy rates, the company observes. "The number of pregnancy reports has not increased appreciably during this period of greater Accutane use," Hoffmann-La Roche says.
But company officials have begun taking additional action. In February, Hoffmann-La Roche began to distribute pregnancy tests to doctors who prescribe the drug. And in June, the company began implementing a "targeted" awareness program, aimed specifically at women of childbearing age.
That's not surprising, considering that Accutane is Hoffmann-La Roche's second largest revenue generator. At the meeting, the company will also ask the committee members to endorse a new once-a-day formulation meant to make the dosing schedule more convenient for patients.
For its part, the FDA is also looking to ask its expert advisory committee whether additional warnings are needed to outline other potential side effects of the medication, such as depression and psychosis.
But before the FDA takes any action, it will have to overcome professional objections. Further restrictions are opposed by the American Academy of Dermatology (ADD), which is concerned that they would make Accutane difficult for patients to obtain.
"Since the product's introduction in 1982, Accutane has proven to be the only medication that safely and effectively controls cystic acne, the most serious form of this skin disease," says Richard Scher, MD, president of the ADD. "Education, not regulation, is the key to safe use of this drug to protect women of childbearing age."