FDA Panel Wants National Registry for Accutane Patients
WASHINGTON, D.C. — March 5, 2004 — Stricter limits must be placed on the prescription of the anti–acne drug Accutane, according to a recent Food and Drug Administration (FDA) advisory panel. The drug causes severe birth defects, including heart and brain damage. Also, Accutane users may experience depression.
The FDA panel wants to create a national registry of Accutane patients. It would require doctors to document that women have received negative pregnancy tests before being prescribed the drug. Women would be told to use two forms of contraception while taking Accutane, and be given monthly pregnancy tests.
The FDA will likely follow the panel recommendations, which come after the failure of a less strict voluntary program known as SMART (System to Manage Accutane Related Teratogenicity). Despite the SMART tracking system, 200 women became pregnant while taking Accutane and other brands of its main generic ingredient, isotretinoin, according to data from manufacturers. A consumers’ advocacy group, Public Citizen, puts this number at 548, with 431 elective abortions. It calls for a complete ban on the marketing of Accutane and recommends making it available to women only under very limited conditions. These requirements would be photographic proof of severe cystic acne, a negative pregnancy test, and a doctor’s written record that the patient did not respond to other treatment.
Accutane and Other Brands of Isotretinoin
Hoffman–La Rouche Inc. is the main manufacturer of isotretinoin under the Accutane brand name. The Ranbaxy, Barr, and Mylan companies also manufacture forms of isotretinoin, and would be covered by the FDA panel recommendations.
Both the FDA and manufacturers agree that isotretinoin should only be prescribed for a serious acne condition called Severe Recalcitrant Nodular Acne (SRNA). However, evidence shows that the drug has been overprescribed for more mild forms of acne. Public Citizen sums up the problem in this way: “This is one of the worst epidemics of preventable serious birth defects ever seen in the U.S. It is time to end the more than twenty years of voluntary restrictions that have failed to reduce [isotretinoin] prescribing …”
At Brayton Purcell, we are concerned about medical problems caused by unsafe or ineffective prescription drugs. If you have been injured by a prescription drug, please feel free to contact us to learn about your legal options. We have been fighting for the rights of consumers for over 20 years and are well–versed in medical/legal issues.