Accutane Risks

Women Who Use Accutane At Risk of Complications

Dr. Diane M. Thiboutot of the American Academy of Dermatology told a federal advisory panel on Feb. 10 that "pharmacies, prescribers and patients are confused and frustrated." Her group is seeking a two-month delay on the mandatory starting date of March 1.

Accutane is an approved treatment of severe acne which casues disfigurement, a condition estimated to afflict only about 6,000 patients, almost all of them male. For these patients, Accutane is a near-miraculous cure.

iPledge, a government-approved system designed to prevent pregnant women from taking Accutane, has been termed a "disaster" by leading dermatology association in the U.S.

People in favor of the reporting program on Accutane for pregnant women said the complaint "exaggerated."

The iPledge system requires female patients to take pregnancy tests and birth control. Doctors maintain that is inconvenient, cumbersome and sometimes impossible to manage for women who want to become pregnant.

More than 40 efforts to prevent women from taking Accutane while pregnant have not been successful. Half of the 170,000 prescriptions written by physicians each year are for women. If a woman becomes pregnant while on Accutane it can result in miscarriages, abortions and deformed babies.

Some doctors have complained of ill-advised instructions from the system, such as requiring pregnancy tests for male patients and long waits on the phone.

But physicians, who are allowed by law to prescribe drugs as they see fit, write more than 170,000 Accutane prescriptions each month. Half go to women, hundreds of whom become pregnant each year, according to federal estimates.

Some said the failure of past systems to limit problems from Accutane for women who want to become pregnant is due to "dermatologists are prescribing Accutane to way too many people."

Covance, the company that operates iPledge, said they are responding to complaints and fixing problems as it is made aware of them. Those fixes could take weeks to carry out and longer to become apparent to others, such as pregnant women.

The Food and Drug Administration said they will decide on the delay request soon.