FDA Approves Accutane Registration Program

Distributors, doctors and patients must sign up to get the acne drug

FRIDAY, Aug. 12, 2005 (HealthDayNews) -- Doctors who prescribe the potent acne drug Accutane, patients who use it and pharmacists who sell it will have to enroll in a national registry to guard against dangerous side effects, particularly birth defects, federal officials announced Friday.

The U.S. Food and Drug Administration confirmed it had signed off on a program called iPLEDGE. It was developed by the manufacturers of the drug at the request of an FDA advisory panel, which in February 2004 said the agency should track women who could become pregnant while taking the drug. The FDA had estimated it would take until July 2005 to implement the program.

Accutane, known generically as isotretinoin, can cause brain and heart damage in the fetuses of women who use the drug, even in small amounts.

"The sponsors of this drug have agreed to implement a program that requires registration and participation in order to dispense, ship or prescribe the drug isotretinoin," said Dr. Sandra Kweder, deputy director of the Office of New Drugs at the FDA's Center for Drug Evaluation and Research.

Under the program, wholesalers, pharmacists, doctors and patients all have responsibilities that are designed to minimize a pregnant woman's exposure to the drug, Kweder said. The program's goal is to ensure that women are not pregnant when they start taking the drug and that they don't get pregnant while using it.

The program will take effect Nov. 1, when manufactures of isotretinoin will only be able to ship the drug to wholesalers who are registered with iPLEDGE. In addition, wholesalers must agree not to ship or sell isotretinoin to pharmacies not registered with the program.

Starting Dec. 31, registered pharmacies must also have authorization from the iPLEDGE computerized system before filling any prescription for isotretinoin, Kweder said.

"Physicians must register their patients in the iPLEDGE system," she said. "The patient must register him or herself with the iPLEDGE system."

When patients -- male and female -- register, they must acknowledge the risks associated with the drug, including depression and suicidal feelings. Moreover, women will have to have a pregnancy test within seven days before filling their prescription. "In addition, women agree to use two methods of birth control and adhere to pregnancy testing on a monthly basis," Kweder said.

The FDA also announced changes to the drug's existing warning labels, to heighten the psychiatric risks that may accompany use of the drug. Although no link has been proven, there have been anecdotal reports of depression and suicidal behavior among people taking Accutane.

The makers of the drug will also supply educational programs about potential side effects. And the iPLEDGE program will include a computerized monitoring system to make sure that all parties follow the regulations.

"We are unaware of any risk-management or restricted-distribution program of such scope and complexity as this," Kweder said.

Accutane was designed to treat severe acne, although it's suspected that many people have used the drug for less-severe cases of acne. An estimated 100,000 prescriptions are written each month for the drug.

One acne expert thinks the registration program will have an unfortunate effect, causing many doctors not to prescribe the drug.

"It just goes to show you how politics can make a difference," said Dr. Marsha Gordon, an associate clinical professor of dermatology at Mount Sinai School of Medicine in New York City. She was referring to several federal lawmakers who have been pushing for stricter regulations governing Accutane. They include Congressman Bart Stupak (D-Mich.), who believes his 17-year-old son's suicide in 2000 was due to Accutane use.

"Accutane is a wonderful and strong medication," Gordon said. "And it does require medical monitoring." But she thinks the registration process is too complicated, and will discourage doctors from prescribing the drug.

"I'm fearful that the level of registration will reduce the number of good physicians who are willing and able to prescribe the medicine, and thereby prevent patients who would benefit from Accutane from getting it," she said.

The makers of isotretinoin include Hoffman-LaRoche, which manufacturers Accutane; Genpharm, the maker of a generic version called Amnesteem that is distributed by Mylan/Bertek; Ranbaxy Pharmaceuticals, manufacturer of the generic version Sotret; and Barr Laboratories, manufacturer of the generic version Claravis.

More information

For more on isotretinoin, visit the U.S. Food and Drug Administration.

SOURCES: Sandra Kweder, M.D., deputy director, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Bethesda, Md.; Marsha Gordon, M.D., associate clinical professor, dermatology, Mount Sinai School of Medicine, New York City; Aug. 12, 2005, U.S. Food and Drug Administration press briefing
Consumer News