FDA Creates Strict Program To Get Acne Drug
Doctors Disagree On New National Registry For Accutane
POSTED: 8:41 pm CST March 1,
2006
UPDATED: 8:55 pm CST March 1,
2006
MADISON, Wis. -- Starting on Thursday, teenagers and adults with severe acne had to sign a national registry to get the most effective acne-fighting drug on the market.The Food and Drug Administration's I-Pledge program is controversial and strict, especially for young women, WISC-TV reported.Alecia Schubert suffered the physical and emotional scars of acne along with millions of other people desperate for a cure."I always felt like people didn't see the real me -- they just saw the acne," Schubert said. "It was just bad. I can't even describe it. It was all over my face, shoulders, my back."After two months of treatment with Accutane, Schubert has started to get rid of the acne.While the product has worked for many people with acne, the FDA developed the I-Pledge program to warn potential users about its side effects, specifically birth defects.Both male and female patients have to fill out paperwork in order to get the drug. Even more, women with acne who are of childbearing age must undergo periodic pregnancy tests and meet additional requirements."If they've had two negative pregnancy tests, they can start the Accutane, but they have to have two forms of birth control," said Dr. Derek Cripps, a dermatologist at UW Health and investigator in the Accutane trials 26 years ago."It kind of makes sense because there are a lot of birth defects if you are on the medication or whatever," Schubert said. "But at the same time, I think it's a little extreme too."Schubert said she has a family history of acne. Her younger brother, Richard Oliphant, was also treated recently with the drug, she said.Oliphant just missed the FDA's program, where someone must also promise not to give blood during treatment or share the drug with anyone."I'm glad I didn't have to do it," Oliphant said. "It looked like a lot of paperwork and stuff like that."WISC-TV talked with a dermatologist who's opposed to the I-Pledge system."This system is not needed at all," Dr. Robert McDonald said. "It's precise to an unworkable degree."McDonald said the guidelines are so precise that if doctors and patients don't follow them exactly, patients might be prevented from getting the drug."Besides wanting to do the right thing for patients, we also want to do the right thing to stay away from the lawyers with this medication," McDonald said.Doctors worry that Accutane might be taken off the market if the rules aren't followed, meaning some families would be forced to find alternative remedies for acne.According to doctors, depression is another side effect of Accutane and three other generic medications that have been developed from it.The FDA said since Accutane went on the market in 1982, there has been more than 2,000 pregnancies among users.
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