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this pageAccutane® Users and Their Doctors Must Enroll in Federal Registry
WASHINGTON, DC — August 19, 2005 — Pharmacies selling Accutane® (isotretinoin), patients who use the drug, and the doctors who prescribe it, must all enroll in a national registry known as iPLEDGE. The program’s goal is to keep pregnant women from using Accutane®, which causes fetal heart and brain damage as well as other serious birth defects. Accutane® may also cause mental retardation in newborns, miscarriages, and premature births.
In 1982, the Food and Drug Administration (FDA) approved Accutane® for treating severe or “nodular acne” that can leave permanent scars. However, medical experts say that Accutane® has been used to treat minor cases of acne, and that pregnancy checks have been too lax.
A voluntary program by drug manufacturers to stop Accutane® use by pregnant women was not successful, according to an FDA panel convened in March of last year. Despite the program known as SMART (System to Manage Accutane Related Teratogenicity), 200 women became pregnant while taking Accutane® and other drugs containing isotretinoin, according to data from manufacturers (FDA Panel Wants National Registry). The FDA puts the number at 2,000 pregnancies since 1982 (CBS News, August 15, 2005).
Accutane® and the iPLEDGE Program
Under the new iPLEDGE program, a woman who is pregnant or breast–feeding may not take Accutane®. She must have two negative pregnancy tests before starting Accutane® treatment, and test negative for pregnancy during every month while she takes the drug. She must also use two forms of birth control.
The former SMART program had similar requirements, but many hope that the iPLEDGE electronic tracking system will prove more effective. Dr. Nancy Green, medical director for the March of Dimes, commented “If this doesn’t work, we will call for the FDA to take this drug off the market.” (New York Times, August 13, 2005).
Beginning December 31, 2005, only pharmacies registered with iPLEDGE can dispense Accutane®, and only to doctors and patients who are also registered with the program. A doctor must provide pregnancy counseling to female Accutane® patients of childbearing age and supply iPLEDGE with their monthly pregnancy test results.
The manufacturers of Accutane® and other isotretinoin–containing drugs will maintain the registry (FDA Press Release, August 12, 2005). These companies 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®. The companies are supposed to halt supplies of Accutane® to women who become pregnant, and to users, doctors, or pharmacies that are unregistered.
Depression and Suicide Linked to Accutane®
In addition to causing birth defects, Accutane® has been linked to depression and suicide. From 1982 through August 2004, the FDA received 4,992 reports of psychiatric problems associated with Accutane® and isotretinoin use (Alert for Health Care Professionals, FDA, August 12, 2005). One hundred ninety Accutane® patients committed suicide through January 2005. The FDA says that this number may actually be larger due to underreporting. It has updated the Accutane® label to warn doctors to look for symptoms of depression in their patients, including sad mood, irritability, anger, loss of interest in social or sports activities, disturbed sleep patterns, changes in appetite, and trouble concentrating (Isotretinoin or Accutane® Capsule Information, FDA, August 12, 2005).
Legal Help for Those Injured by Accutane® and Other Unsafe Medical Drugs
At Brayton Purcell, we are concerned about medical problems caused by unsafe or ineffective prescription drugs such as Accutane®. 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.