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FDA May Extend Accutane Program Deadline

Americans who take Accutane (isotretinoin) may have more time to register for "iPledge", a program designed to limit pregnant women's use of the drug, which causes birth defects. The US Food and Drug Administration (FDA) will decide next week whether or not to extend the deadline for program registration.

Accutane is prescribed for severe acne that is untreatable by other drugs. However, clinical tests have shown that Accutane significantly increases the rate of birth defects in children of women who are pregnant when taking the drug, or who take it within one month of becoming pregnant.

The possibility of delaying the program was reported by on February 13, 2006.

The iPledge System

To more closely track women who are taking Accutane, the FDA has set up iPledge, a registration system for doctors, patients and drug-wholesalers and pharmacies. All are required to register and be active within the computerized iPledge system by March 1st, 2006. Doctors and pharmacies not registered by that date may not prescribe or sell isotretinoin.

The FDA developed iPledge because about 100-140 pregnancies annually are still being reported in the US by women taking isotretinoin, which is sold under the brand name Accutane, as well as in three generic versions: Amnesteem, Claravis and Sotret.

Because of programming problems, and slow progress with registration, the American Academy of Dermatology Association and other groups have reportedly requested a delay in initiating the program. Ongoing problems with the new Medicare prescription-drug benefit may also be contributing to the delaying the registry.

The FDA plans to make a decision in the next week about whether or not to extend the deadline, according to Dr Sandra Kweder, deputy director of the FDA's Office of New Drugs, says

Regulating Isotretinoin

The iPledge program is FDA's most recent attempt in 20 years of trying to limit the fetal exposure to isotretinoin, according to It replaces and expands on four smaller similar registries managed by the individual manufacturers of each isotretinoin drug.

The child of a woman who uses isotretinoin during pregnancy or within a month of taking becoming pregnant has a significantly elevated risk of heart and brain defects and mental retardation.

Isotretinoin is prescribed to about 100,000 Americans each month. However, as of last week, the iPledge program had only 17,881 registrants, according to James Shamp, a director of Covance Inc, which runs iPledge, reported.

In total, about 88% of the US's 55,000 pharmacies have registered, according to Shamp, but only 56% of an estimated 36,000 doctors who prescribe isotretinoin have registered.

Since Accutane went on the market in 1982, the FDA has received reports of more than 2,000 pregnancies among women using the drug. Most of these pregnancies ended in abortion or miscarriage, but the FDA has recorded that over 160 babies have been born with drug-related defects.

FDA Considers Extending Accutane Deadline,, February 13, 2006.

Posted: February 2006