FDA Panel Backs New Restrictions on Popular Acne Drug
Sep. 18, 2000 (Washington) -- After nearly 20 years on the U.S. market, the popular acne drug Accutane may now face new restrictions on its distribution and use, due mostly to its well-documented ability to cause birth defects.
A panel of expert government advisors Monday recommended that the FDA require both prescribers and users to register with a national database. The panel also recommended that prescriptions be limited to 30 days, and that women be required to have a pregnancy test prior to receiving their monthly prescription.
The Hoffmann-La Roche drug is a treatment for severe recalcitrant nodular acne. This severe form of acne often results in disfiguring scarring and psychological trauma if left untreated.
The panel was concerned about restricting the use of Accutane in women of childbearing age. Since its approval in 1982, a total of 1,995 pregnancies have been reported by women on the drug despite the drug's well-known ability to cause birth defects. These pregnancies resulted in 383 live births, of which about 42% ended in a birth defect.
The first cases of drug-related birth defects were reported in 1983. Since then, the company has taken a number of steps to prevent pregnancies in women taking the drug, including the distribution of more than a dozen "Dear Doctor" letters to inform physicians, pharmacists, and other health care professionals about these potential adverse events.
In 1988, the company also initiated a Pregnancy Prevention Program (PPP). This first-of-its-kind risk-management program was aimed at preventing pregnant women from taking Accutane and preventing those women already on Accutane from becoming pregnant. Among other things, the program stressed the importance of preventing pregnancy, and the significance of using at least two forms of birth control while on the drug.
Despite these efforts, pregnancies continued to occur. In fact, of the 1,995 pregnancies reported since the drug's approval in 1982, about 70% occurred after the PPP was implemented, according to FDA figures.
This absolute number also does not paint the entire picture, says Amarilys Vega, MD, MPH, an epidemiologist in the FDA's office of Postmarketing Drug Risk Assessment. Under-reporting of adverse events is significant, she explains. "We need better means to enumerate pregnancy rates on Accutane. How many pregnancies occurred [among Accutane users] in 1999? No one is sure," Vega says.
Still, there are concrete figures to establish that the PPP program is insufficient, Vega says. Based upon the responses of about 500,000 women that voluntarily enrolled in a study conducted by Boston University's Slone Epidemiology Unit, an estimated 25% of women prescribed Accutane receive no pregnancy test and another 33% begin treatment without first obtaining the results of their pregnancy test, she says.
"There are unacceptable high percentages of physicians and patients not complying with the components of the PPP," Vega says.