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Subscribe To Our Syndicated NewsFDA Tightens Accutane Rules Due to Risk
FDA Tightens Accutane Rules Due to Risk
October 31 , 2005
In August 2005, the FDA announced a new Accutane program called iPLEDGE. This government-mandated drug safety program will involve all parties who supply, prescribe, or use the acne drug Accutane. While Accutane is an effective treatment for moderate to severe acne, it can cause serious birth defects and other significant side effects. The new compulsory program is intended to replace an ineffective voluntary program to prevent pregnancy in Accutane patients.
In the past, the FDA implemented a voluntary pregnancy prevention program designed to prevent pregnant women from taking Accutane, and, Accutane patients from getting pregnant. Under these old guidelines, women were to receive birth control counseling and have two negative pregnancy tests before being prescribed Accutane. Women were also urged to have a monthly pregnancy test during the course of Accutane treatment.
A recent study shows that some women were not being informed about the serious risks associated with Accutane and pregnancy. Birth defects researchers conducted a study about Accutane patients and pregnancy under the FDA's old program. The report included 34 women who took Accutane while pregnant between April 2002 and September 2004. The majority of these women were not informed about the risks of Accutane birth defects. One-third of these women received no birth control counseling and nearly three-quarters said they did not have a second pregnancy test before beginning Accutane. Half of these patients said they did not have monthly pregnancy tests while using Accutane.
This study also showed that few of these women actually had the type of acne for which Accutane is supposed to be prescribed. This is another major issue associated with Accutane: many people are being prescribed this powerful and dangerous drug when there acne condition does not warrant the use of Accutane. The FDA has only approved Accutane for patients with moderate to severe acne. Accutane is not approved for people with mild acne, though this patient group makes up a huge percentage of those who are prescribed Accutane.
Under the new FDA rules, women of childbearing age must complete the following in order to use Accutane: sign an informed consent form, register personally with the iPLEDGE program, get two negative pregnancy tests seven days before starting Accutane, agree to use to kinds of birth control, and have a negative pregnancy test before receiving a monthly Accutane refill. Doctors are required to counsel their patients on birth control and Accutane risks, register with iPLEDGE, and ensure that patients comply with the FDA Accutane program. Pharmacies must also log into the iPLEDGE to ensure that all requirements have been met before giving a patient their Accutane prescription. Wholesale distributors must only give Accutane to pharmacies registered with iPLEDGE.
For more information on Accutane, please contact us.
