"iPLEDGE" Registry for Accutane Patients Is Mandatory Starting In 2006
Primary Aim Is To Reduce Number Of Accutane-related Birth Defects
Enrollment in the "iPLEDGE' national registry for the anti-acne drug Accutane is mandatory starting January 1, 2006.
This "iPLEDGE" registry concerns any and all doctors, patients, and pharmacists involved with Accutane (isotretinoin), or the three generic versions of the drug, which are known as Amnesteem, Claravis, and Sotret.
About 100,000 Americans a month use Accutane and its generic versions (hereinafter, collectively referred to as Accutane). If a woman uses Accutane during pregnancy -- or becomes pregnant within a month of taking Accutane -- her baby runs a significant risk of suffering brain and heart defects or mental retardation.
According to Dr. Paul Seligman, director of the FDA office responsible for post-marketing drug surveillance, although the FDA has tried for more than 20 years to limit the exposure of fetuses to Accutane, anywhere from 100 to 140 pregnancies a year are still being reported in women using Accutane. "We hope [iPLEDGE] will be the program that ensures that we can get as close to the goal of the least pregnancy exposures as possible," Seligman said.
All Accutane users must enroll by telephone at (866) 495-0654 or through the Internet at http://www.ipledgeprogram.com in order to receive the drug after January 1, 2006.
Furthermore, each Accutane user must sign a document informing them of serious side effect risks associated with Accutane, including the possibility that the anti-acne drug contributes to depression or suicidal thoughts.
In addition, all female patients of childbearing age who plan to use Accutane must:
- undergo two pregnancy tests before the initial Accutane prescription can be filled;
- have a monthly follow-up pregnancy test before each Accutane refill;
- use two different forms of birth control at the same time or agree not to have sexual intercourse for one month before starting Accutane, during the entire course of Accutane treatment, and for one month after her Accutane treatment has ended.
Accutane is approved by the FDA for treatment of only the most severe acne, but the drug is widely prescribed "off-label" for more minor cases of acne.
The FDA has received reports of more than 2,000 pregnancies among Accutane users since it was introduced to the U.S. market in 1982. Of those pregnancies, most ended in abortion or miscarriage, but the FDA has received reports of more than 160 babies born with Accutane-related birth defects.
It is generally thought that less than ten percent of adverse drug reactions and serious side effects in the U.S. are ever reported to the FDA, so the number of birth defects caused by Accutane over the years is most likely significantly higher than 160.
Visit the FDA's dedicated web page for more information about Accutane.
(Posted by: Tom Lamb)
