Dermatology Association wants Delay of iPLEDGE Accutane FDA Program - Acne Drug linked to Birth Defects

February 11th 2006

Dermatology Association wants Delay of iPLEADE Accutane FDA Program - Acne Drug linked to Birth Defects

Acne

The government approved a system for preventing pregnant women from taking Accutane. The drug has been linked to miscarriages and severe birth defects. The American Academy of Dermatology, the largest dermatological association, has asked the Food and Drug Administration (FDA) to delay the March 1st implementation date by two months.

The Academy urged the FDA to “postpone” the new iPLEDGE system because dermatologists across the country are reporting numerous flaws in the program “that are interfering with patient care and could affect patient safety.”

Accutane, and the generic Isotretinoin, has been approved to treat severe disfiguring acne with great results. According to the New York Times, the condition afflicts only about 6,000 patients, nearly all of them male. But the drug is prescribed to more than 170,000 patients, of which about half are women.

The health risks arise when the drug is prescribed to women that may become pregnant or who are already pregnant. The federal government has undertaken more than 40 efforts since 1982, when the drug was approved, to prevent women from taking the drug while pregnant. The problem persists.

All four of the Isotretinoin / Accutane manufacturers have agreed to construct a system that requires doctors, pharmacists and patients to control the drug’s distribution. The fear is that the system may send patients to the Internet, “where medicines may be counterfeit and there are no safeguards to prevent pregnancy”, according to Reuters.

The March of Dimes says more than 1,000 women have become pregnant while using Accutane. March of Dimes is a group working to prevent birth defects, and has been working for “two decades to improve the inadequate voluntary programs for regulation of isotretinoin”, according to their press release. The iPLEDGE program was praised by the March of Dimes back in August after the program’s announcement was made.

Some dermatologists have already started complying with the program at the end of last year. Dr. Diane Thiboutot of the American Academy of Dermatology Association told the FDA "The results today are a disaster. Pharmacists, prescribers and patients are confused and frustrated."

IPLEDGE supporters insist the March 1st deadline not be changed. The Public Citizen Advocacy group has worked for two decades in support of stronger controls on the drug and has said in a January 2006 press release “almost 25 years after initial marketing and the knowledge of teratogenicity, there are more restrictions than ever before, but these are probably still not adequate.”