Accutane is a popular medication used to treat severe acne cases. The FDA approved Accutane only for acne that cannot be treated by other medications. Accutane is widely used with more than one million prescriptions a year in eighty different countries.   

Accutane use has been linked to severe birth defects in users that are pregnant or within a month of becoming pregnant. On March 1, 2006, the FDA implemented the iPLEDGE program to halt the birth defects caused by pregnant women taking Accutane. The iPLEDGE program requires wholesalers, pharmacies, and patients to register with the program registry in order to give or receive an Accutane prescription. Female patients of child bearing potential that want an Accutane prescription must show a recent negative pregnancy test and promise to use two contraceptives to avoid becoming pregnant during Accutane use. The FDA also requires the iPLEDGE program’s sponsors to provide educational programs and materials for all parties in the program.  

The FDA disclosed that about 25% of babies born to mothers taking Accutane have serious birth defects and 50% of the children develop mental retardation. Additionally, Accutane use by pregnant women increases the risk of a miscarriage threefold. Unfortunately, many women that become pregnant while taking Accutane decide to voluntarily terminate their pregnancies because of the increased risk for birth defects.  For more information about birth defects from accutane use, please contact us or read more here.

In 1998, the FDA required Hoffman-LaRoche, Accutane’s manufacturer, to add a black box warning to Accutane’s label, notifying users that Accutane was linked to depression and suicide. The FDA also requires patients to sign a consent form stating they understand the risk of depression and suicide. Pharmacists must also distribute a Medication guide detailing the psychological Accutane side effects.

The FDA required the black box warning after receiving more than 200 reports of suicides by Accutane users and more than a thousand reports of psychological complications. A study revealed that Accutane users are 1.5 times more likely to commit suicide than non-users. Accutane’s link to suicide received national attention when Congressman Bart Stupak’s son committed suicide after taking Accutane. Please contact us for more information about Accutane depression and suicide and to learn about your legal rights.

If you or a loved one may have been injured by Accutane, please contact our Accutane injury lawyers today. You may be entitled to recover compensation for your injuries. 

Published November 17, 2011 by