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FDA Considers Postponing Deadline For Acne Drug Users, Doctors To Register For IPledge Program
FDA officials on Friday said they are considering postponing the mandatory start date for a program that seeks to reduce the number of pregnant women who use the acne medication isotretinoin -- sold under the brand name Accutane -- after glitches in the program have delayed registration, the AP/Olympian reports (Bridges, AP/Olympian, 2/10). FDA on Dec. 30, 2005, began to register physicians, prescription drug wholesalers, pharmacists and women into the program, known as iPledge, after an FDA advisory committee in March 2004 recommended the program. Studies have found that isotretinoin can cause severe side effects in pregnant women, such as birth defects and fetal death, and might cause depression and suicide. Under the program, women must submit two negative pregnancy tests before they can receive an initial prescription for isotretinoin and must undergo a monthly pregnancy test before each refill. In addition, women must agree to use two forms of birth control at the same time or to abstain from intercourse for one month prior to treatment with isotretinoin, during treatment and for one month after treatment has ended, according to FDA. Women also must sign a document to acknowledge that isotretinoin increases risk for birth defects, depression and suicidal thoughts. The program also requires physicians who prescribe isotretinoin and wholesalers and pharmacists who distribute the medication to register with the database. Pharmacists must consult the database before they fill prescriptions for isotretinoin to ensure that women have complied with the program's requirements (Kaiser Daily Women's Health Policy Report, 1/4). About 88% of the nation's 55,000 pharmacies and 56% of the estimated 36,000 doctors who prescribe Accutane have registered with system, according to James Shamp, director of Covance, which runs iPledge. As of Wednesday, 17,881 patients had registered with the program, Shamp said (AP/Olympian, 2/10). FDA Panel Hearing
Diane Thiboutot of the American Academy of Dermatology on Friday told an FDA advisory panel that the iPledge program is a "disaster." Thiboutot said, "Pharmacies, prescribers and patients are confused and frustrated," and asked the panel to delay the system's mandatory starting date of March 1 by at least two months. According to the New York Times, doctors have complained of long waiting times on the phone and "nonsensical" instructions from the system, such as requiring pregnancy tests for male patients. Arthur Levin, a panel member who is director of the Center for Medical Consumers in New York City, said the system's problems "have to be addressed very quickly," adding, "I think it would be tragic if this kind of program got a bad reputation." Sandra Kweder, FDA's deputy director of the office of new drugs, said the agency within a week would decide whether to delay the program's deadline (Harris, New York Times, 2/11).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
FDA considerã amâna termenul limitã pentru acnee utilizatorilor de droguri, medici sã se înregistreze pentru programul de IPledge - FDA Considers Postponing Deadline For Acne Drug Users, Doctors To Register For IPledge Program - articole medicale engleza - startsanatate
