February 13, 2006 ANDREW BRIDGES WASHINGTON - The tens of thousands of Americans
who take Accutane to treat their severe acne may gain additional time to register
with a program designed to limit use of the birth defect-causing drug by pregnant
women, health officials said Friday.
Doctors and patients, along with wholesalers and pharmacies, are supposed
to be registered and activated in the computerized iPledge system by March 1 if
they want to sell, prescribe or take the acne drug isotretinoin. Isotretinoin is
sold as Accutane and in three generic versions: Amnesteem, Claravis and Sotret.
But glitches in the program, as well as the slow progress in registering patients
and others, have led to calls for a delay by the American Academy of Dermatology
Association and others. The ongoing problems with implementing the new Medicare
prescription drug benefit may be complicating the debut of the registry as well,
officials said.
The Food and Drug Administration will decide in the next week whether to extend
the deadline, said Dr. Sandra Kweder, deputy director of the regulatory agency's
Office of New Drugs.
The registry program is the latest in 20 years of FDA efforts to limit the exposure
of fetuses to isotretinoin. If a woman uses the drug during pregnancy, or should
become pregnant within a month of taking it, her baby runs a significant risk of
brain and heart defects, as well as mental retardation.
The iPledge program is to replace and expand on four smaller registries run by the
drug's individual manufacturers. The FDA sought the new program because of the estimated
100 to 140 pregnancies a year still being reported in the United States in women
on the drug.
The drug is prescribed to about 100,000 Americans a month. As of Wednesday, just
17,881 patients had registered with the program, according to James Shamp, a director
of Covance Inc., which runs iPledge.
Most, or 88 percent, of the nation's 55,000 pharmacies have registered, according
to data presented by Shamp. However, just 56 percent of the estimated 36,000 doctors
who prescribe isotretinoin were registered as of Wednesday.
Since Accutane sales began in 1982, the FDA has received reports of more than 2,000
pregnancies among users. Most ended in abortion or miscarriage, but the FDA counts
more than 160 babies born with drug-caused defects.
Breaking News
FDA considers extending mandatory registry deadline for acne drug Accutane