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Acne Drug Restrictions Fuel Debate

'iPledge' Designed to Prevent Exposure to Accutane During Pregnancy

Doctors Protest continued...

"The bottom line is, we just don't think it's going to work," he says.

Accutane is sold by Swiss company Hoffmann-La Roche Inc. Three other firms sell the drug in generic forms. Roche reported to the FDA in 2004 that 183 women took the drug while pregnant during its earlier tracking program, compared with 150 in the year before. Generic manufacturers reported 19 more cases since December 2002 while using identical tracking programs.

Covance spokeswoman Laurene Isip said in an emailed statement that the company believes iPledge will be effective and simpler than earlier safety programs. "The program strives to ensure that no woman starts therapy if she is pregnant and that no woman taking isotretinoin becomes pregnant during treatment for one month afterward," the email stated.

Unsuccessful Programs

An earlier restriction program, known as SMART, largely failed to prevent pregnant women from taking isotretinoin.

Rep. Bart Stupak (D-Mich.), a sharp critic of the drug, criticized the iPledge in an interview as being too lax. The program only requires the registration of pharmacies, not individual pharmacists, and carries no penalties for prescribers who don't comply, he says. The program should also track psychiatric side effects, which some reports have linked to depression and suicide in users, Stupak says.

"It's better than what we had, but it's nowhere close to good enough," says Stupak, whose 17-year-old son committed suicide while taking Accutane in 2000.

"There are no consequences, so it's just going to be ignored," he says.

Isip says that the company was developing plans to track the program's effectiveness.

You can contact the iPledge call center 1-866-495-0654 Monday-Saturday 9 a.m. - midnight EST and through the web site at www.ipledgeprogram.com.

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