FDA To Restrict Distribution of Accutane To Reduce Birth Defects, Fetal Deaths
FDA on Friday said all health care providers prescribing Accutane and generic versions of the acne drug, known as isotretinoin, and any patients taking the medication must enroll in a central registry system in an effort to prevent pregnancies among women taking the drug, which is known to cause severe birth defects, AP/USA Today reports (Neergaard, AP/USA Today, 8/12).
An FDA advisory panel in March 2004 recommended the strengthened distribution program. Studies have shown that isotretinoin can cause severe side effects in pregnant women, such as birth defects and fetal death, and also might cause depression and suicide. FDA last year released data that showed that strict measures enacted to reduce the number of birth defects related to isotretinoin have had little effect on the number of women who take the drug while pregnant.
Female patients of childbearing age are required to use two forms of contraception, can only receive a 30-day supply of the drug and are required to take monthly pregnancy tests before they can get a refill (California Healthline, 11/24/04).
The new plan, which is set to begin Dec. 31, will require doctors who prescribe isotretinoin, pharmacists who dispense the drug and patients who take it to register with a central clearinghouse, called iPLEDGE, the South Florida Sun-Sentinel reports. In addition, women of childbearing age who are prescribed isotretinoin must present two negative pregnancy tests before obtaining an initial prescription and must have monthly pregnancy testing prior to refilling a prescription for the drug (McVicar, South Florida Sun-Sentinel, 8/13).
FDA also is requiring all patients seeking a prescription to sign a document informing them of the drug's risks. Patients must agree to meet with their physician each month and not share their pills with anyone. Afterward, the physician registers each patient into the iPLEDGE database, providing him or her with a special identifying code number, and prescribes the medication (AP/USA Today, 8/12).
According to FDA, the pharmaceutical company Celgene -- which manufactures Thalomid, a drug also known to cause severe birth defects when taken by pregnant women -- will license the rights to the national registry it developed for that drug to Accutane manufacturer Roche and isotretinoin makers Barr Laboratories, Mylan Laboratories and Ranbaxy Laboratories so they can establish a similar registry for isotretinoin users. The companies have hired Princeton, N.J.-based clinical research company Covance to develop the registry (California Healthline, 11/24/04).
Steven Galson, director of FDA's Center for Drug Evaluation and Research, said, "iPLEDGE, using a computer-based and telephone system, will provide health care professionals with the real-time information necessary to effectively manage the risks of isotretinoin" (CQ HealthBeat, 8/12).
Roche spokesperson Shelley Rosenstock said the company is in favor of the rules. "Roche continues to support, to the extent possible, efforts to reduce fetal exposures" to Accutane, she said (Harris, New York Times, 8/13).
However, drug safety officer David Graham, who testified in the fall before Congress about the risks of Accutane, said that the system "will not sufficiently reduce the use of Accutane for less severe forms of acne," adding, "A restricted distribution system should have been in place 15 years ago, and FDA scientists from both the drug safety office and the [drug] reviewing division were urging that it be adopted" (Alonso-Zaldivar, Los Angeles Times, 8/13).