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Panel urges registry for Accutane patients

http://www.cnn.com/2004/HEALTH/02/28/accut...y.ap/index.html

Panel urges registry for Accutane patients

#WASHINGTON (AP) -- Users of the acne drug Accutane may soon find it tougher to get. Government advisers want major new curbs to prevent pregnancy among female patients because it causes birth defects.

Under the plan, every patient -- men and women -- as well as health workers who prescribe Accutane and drugstores that dispense it, would have to enroll in a national registry.

The system would require that women get a pregnancy test before getting their monthly supply of Accutane, and that they be told to use two forms of contraception while taking the drug.

Drugstores would have to ensure women have been properly cleared by their prescriber before handing over the drug, scientific advisers to the Food and Drug Administration concluded Friday.

New controls have been recommended because if a woman becomes pregnant while taking Accutane or generic isotretinoin, her baby can suffer severe brain and heart defects, mental retardation and other abnormalities, even if the mother took only a small dose for a short period.

There is a risk for 30 days after stopping the drug, too.

Accutane has posed a birth defect problem since it hit the market in 1982. Warning after warning to doctors and patients failed to help. So in 2001, the FDA began a program where doctors were supposed to do extensive pregnancy testing and contraceptive education before prescribing Accutane -- but it is a voluntary system that the agency acknowledges has failed to reduce pregnancies.

"We have a responsibility to prevent further injury," said Arthur Levin of the Center for Medical Consumers, as his fellow advisers voted 16-8 for a mandatory registry system.

Panelists said they were moved by mothers who pleaded for better protections.

"Warning is simply not enough," said Debbie Banner, of Virginia Beach, Virginia. She said another side effect of Accutane -- depression -- can lead women to disregard or not understand the need for contraception. She blames a drug-caused bout of severe depression on unprotected sex while using Accutane.

"I was devastated that I played a role in my own son being deformed," said Banner, whose 7-year-old has serious brain damage.

'No change is really not acceptable'

FDA is not bound by the panel's recommendations but typically follows them. The agency pledged a quick decision.

"Doing nothing and making no change is really not acceptable," said Dr. Sandra Kweder, of FDA's drug evaluation center.

Accutane manufacturer Hoffmann-La Roche and generic makers support the registry plan.

"We're very pleased with the outcome," said Hoffmann-La Roche spokeswoman Carolyn Glynn. "I think everyone's goal was the same, which was to make sure it remains available to women and to men."

The advisers did not specify just how compliance with the registry would be enforced, something that the drug manufacturers are grappling with.

Roche wouldn't say how soon the registry could begin. "It is a priority," said Glynn.

Despite new controls, pregnancies won't be eliminated, FDA's advisers said.

"There's a certain limit to what we can do," said Dr. Robert Katz, a Rockville, Maryland, dermatologist who told of a patient who insisted with each monthly Accutane prescription that she was not sexually active -- until the day she called him in a panic that she had missed a menstrual period.

"You can't completely control human behavior," he said.

Part of the problem is that Accutane is prescribed too often, said FDA adviser Dr. Eileen Ringel, a Waterville, Maine, dermatologist. It is intended for people with very severe acne, the kind that causes large cysts and leaves deep scars, yet "females are being treated for less severe acne with Accutane," she said.

Under the plan, male patients also would enroll to ensure they are told not to share Accutane with any women.

The FDA has well over 2,000 reports of isotretinoin users becoming pregnant since 1982. Critics note there likely were more because doctors are not required to report Accutane-linked pregnancies to the agency.

The vast majority of such pregnancies ended in abortion. While some healthy babies were born, the FDA counts more than 160 babies born with Accutane-caused birth defects since 1982.

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