iPledge Program for Pregnancy & Birth Defect Prevention Lacking

 Posted on December 13, 2013 in Birth Defects

Isotretinoin, also known as Accutane and one of the most effective medications for acne, is reported to cause severe birth defects to an exposed fetus. Because of this, the U.S. Food and Drug Administration created the computer-based risk management program iPledge, requiring women to review educational materials, complete tests and pledge to use two forms of birth control prior to using the drug.

However, a recent report indicates that the iPledge program been less than successful, and a small study suggests the focus be placed on more highly effective birth control methods. Dr. Eleanor Bimla Schwarz, director of the Women's Health Services Research Unit of the Center for Research on Health Care at the University of Pittsburgh and the senior author of the study, stated, “What we found is that people need a clear message about what birth control would be most effective, and currently the iPledge materials don't make it clear to most women who enroll in the program.” Schwarz also told Reuters Health that women who take isotretinoin need more information on IUDs and implants to better protect themselves from pregnancy.

While the iPledge website clearly states the high risk of severe birth defects that isotretinoin can have on an exposed fetus, earlier studies also indicate that the program and previous initiatives have had “limited or no success to prevent pregnancies among women taking the drug.” And according to the American College of Obstetricians and Gynecologists, IUDs and contraceptive implants are the most effective reversible contraceptive, and “do not require ongoing effort on the part of the user for long-term and effective use.” In an email to Reuters Health, a spokesperson for the FDA stated that the agency cannot comment on this specific study or the validity of the statements.

If you or someone you know is taking isotretinoin, or any drug that may cause painful side effects or birth defects, contact an Illinois defective drug or birth defect attorney who can provide you with knowledgeable legal representation.