FDA Toughens Warnings, Restrictions for Accutane
The FDA is developing tougher restrictions for the prescription, distribution and administration of the "powerful" acne drug Accutane, AP/Philadelphia Inquirer reports. Accutane bottles will soon come with attached MedGuide brochures detailing the drug's side effects, which include a "possible, but not proven," link to suicide, health officials told a House committee yesterday. Other side effects include birth defects and "possible" depression. Before taking the drug, patients will have to sign a paper stating that they understand the risks outlined. Both the "tougher" patient informed-consent forms and the MedGuide brochures could be distributed as early as next month, according to Dr. Jonca Bull, the FDA's deputy drug head. The FDA is also examining stricter regulations on who may prescribe and take the drug. While Accutane is prescribed for individuals with "severe" acne that causes large cysts and deep scars, "critics" estimate that most of the 500,000 Americans who take it each year have acne "too mild for the drug." In addition, Accutane has been linked to serious side effects. Its "best-known risk" is "severe" birth defects, a problem so serious that physicians have advised women to use two forms of birth control while using the drug. However, since Accutane's debut on the market in 1982, 2,000 women have become pregnant while taking it (Neergaard, AP/Philadelphia Inquirer, 12/6).
Members of the House Government Reform Committee yesterday questioned why Accutane maker Hoffman-La Roche and the physicians who write prescriptions for the drug have not been "more aggressive" in publicizing the drug's connection to psychiatric problems. Accutane has listed depression as a "possible" side effect in its package insert since 1986, and in 1997, French authorities required adding risk of suicide to the insert of the European version of the drug. However, the FDA did not require suicide to be listed as a possible risk until 1998 (Rubin, USA Today, 12/6). While the FDA has received 66 reports of suicide among current or former Accutane users, the agency has stated that there is "no scientific proof" that the drug causes depression or suicide (AP/Philadelphia Inquirer, 12/6). Rep. Dan Burton (R-Ind.), however, pointed out that the FDA has received 1,373 reports of "other psychiatric adverse events" in Accutane users, and Rep. Henry Waxman (D-Calif.) noted that reports submitted to the FDA compose only 1% to 10% of all adverse cases from the drug (USA Today, 12/6).
Douglas Jacobs, a Harvard University suicide "expert" and consultant to Hoffman-La Roche, downplayed the link between the drug and suicide to Congress yesterday, stating that many users could have suffered depression before taking Accutane. In addition, Jacobs said, Accutane "does not seem to cause the brain chemical changes necessary to spark depression." The possible link between suicide and Accutane came into public attention in October, when Rep. Bart Stupak (D-Mich.) "blamed" Accutane for the suicide of his 17-year-old son. The FDA is currently working with Hoffman-La Roche and the National Institutes of Health to study the possible link between Accutane and depression (AP/Philadelphia Inquirer, 12/6).
In other FDA drug news, a group of medical experts from the U.S. Anti-Doping Agency, the American Academy of Pediatrics and the American College of Sports Medicine yesterday urged the FDA to ban over-the-counter sales of androstenedione, the Orlando Sentinel reports. Androstenedione, or "andro," is a body-building additive "widely" used by teenagers and athletes and found in many products sold in gyms and health-food stores. The group of health officials, along with the FDA, will work to compile evidence documenting the substance's "ill effects" in adolescents and adults. Last year, the Federal Trade Commission required makers of andro-based products to list side effects of the substance, which include unwanted changes in male and female sexual characteristics and danger to people at risk for prostate or breast cancer, on the labels of the products. In addition, the group of medical experts plans to compile reports of other negative side effects, such as stunted growth, premature baldness, excessive body and facial hair in women and breast growth in men. The group hopes to eventually make the substance, currently classified as a "dietary supplement," declared a "steroid" and made available only by prescription (Shrieves, Orlando Sentinel, 12/6).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.