FDA Warns Pregnant Women about Acne Drug Accutane
By Alan Fein
The Food and Drug Administration has launched a program called iPLEDGE to warn women about the acne drug Accutane because the drug carries a significant risk of birth defects.
Aug 16, 2005 (AXcess News) Washington - The Food and Drug Administration has launched a program called iPLEDGE to warn women about the acne drug Accutane because the drug carries a significant risk of birth defects.
Isotretinoin (Accutane and its generics) is a highly effective drug for severe acne, but it carries a significant risk of birth defects if taken during pregnancy, the FDA said.
The FDA said that manufacturers are implementing a program that requires registration in iPLEDGE by doctors and patients who agree to accept specific responsibilities before receiving authorization to prescribe or use the drug. Wholesalers and pharmacies must also comply with the manufacturers' program requirements in order to distribute and dispense the product.
"This stronger program is a major step in protecting against inadvertent pregnancy exposure by tightly linking negative pregnancy testing with dispensing of isotretinoin." said Dr. Steven Galson, Director, FDA's Center for Evaluation and Research. "iPLEDGE, using a computer-based and telephone system, will provide health care professionals with the real time information necessary to effectively manage the risks of isotretinoin."
In February 2004, at a joint meeting, the FDA's Drug Safety and Risk Management Advisory Committee and Dermatologic and Ophthalmic Drugs Advisory Committee reviewed the existing isotretinoin risk management programs in effect at that time. Based upon their review, the joint committee called for major improvements in the restricted distribution program, including mandatory registration to ensure that patients who could become pregnant have negative pregnancy testing and birth control counseling before receiving the drug.
To inform health care providers about iPLEDGE, the FDA has issued a Public Health Advisory and revised the Patient and Health Care Provider Information Sheets that detail the tightened restrictions and increased responsibilities under iPLEDGE for prescribing, dispensing, distributing, and obtaining isotretinoin.
To obtain the drug, in addition to registering with iPLEDGE, patients must comply with a number of key requirements that include completing an informed consent form, obtaining counseling about the risks and requirements for safe use of the drug, and, for women of childbearing age, complying with required pregnancy testing.
Under the program, after October 31, 2005, wholesalers and pharmacies will have to register with iPLEDGE to obtain isotretinoin from a manufacturer. Starting December 31, 2005, all patients and prescribers (doctors) must register and comply with requirements for office visits, counseling, birth control and other responsibilities.
The manufacturers participating in the iPLEDGE program include Hoffman-LaRoche manufacturer of Accutane; Genpharm manufacturer of Amnesteem which is distributed by Mylan/Bertek; Ranbaxy Pharmaceuticals manufacturer of Sotret; and Barr Laboratories manufacturer of Claravis.
Source: US Food and Drug Administration
http://www.axcessnews.com/health_081605.shtml
FDA Warns Pregnant Women about Acne Drug Accutane
