Acne Product Accutane May Cause Severe Pregnancy Complications

Accutane is a highly effective drug to treat severe acne, but it has disastrous consequences if a woman becomes pregnant while taking it. The drug has been linked to miscarriages and severe birth defects. The system, called iPledge, set up to guard against such possibilities is flawed. Each year, hundreds of women who receive prescriptions from their physicians for Accutane become pregnant while taking it.

The Federal government has vainly tried over the last two decades to institute safeguards against pregnancies in women on Accutane. The iPledge system requires women to take pregnancy tests and to be on birth control. Doctors complain that this inconvenient, cumbersome process is often impossible to manage.

The iPledge program is flawed, in some cases requiring pregnancy tests for male patients. Confusing instructions, lengthy delays in responding to complaints, and extensive waiting time on the telephone help line are common problems.

Some doctors advocate more regulation of Accutane. Others are fearful that the drug will become unavailable for the 6,000 patients — most of them male — with severe, disfiguring acne. For them, Accutane is a near-miraculous cure.

Physicians write more than 170,000 Accutane prescriptions each month, half of those for women.
Dr. Sidney Wolfe, director of health research at Public Citizen, complains that dermatologists are prescribing Accutane to “way too many people.” For this reason, he believes that efforts to limit pregnancies have failed.

Many dermatologists emphasize that Accutane can transform the lives of patients with even mild forms of acne by restoring their self-esteem. The controversy continues and may ultimately result in having Accutane withdrawn from the market.

New York Times, 2/11/06; from an article by Gardiner Harris

Add comment March 19th, 2006