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Published on Aug 15, 2005 by Edgar Snyder

Accutane & Pregnancy Don’t Mix


If you think Accutane is the wonder drug to end hard-to-cure acne, look closer. For pregnant women, Accutane can have devastating effects, causing severe birth defects to the hearts and brains of their unborn babies.

That’s why the Food and Drug Administration (FDA) is imposing strict guidelines on how Accutane and its generic version are prescribed. Since its inception in 1982, Accutane has been blamed on more than 2,000 abortions or miscarriages and more than 160 babies were born with serious drug-caused defects. Critics claim there were likely more but doctors haven’t been required to report Accutane-linked pregnancies. Additionally, the risk of birth defects continues for 30 days after a woman stops taking Accutane.

New FDA rules for dispensing Accutane seek to prevent potential birth defects with the use of an online database named iPLEDGE and the following guidelines:

  • All patients must agree to monthly doctor visits for refills and not share the pills. Doctors will also register all patients in the iPLEDGE database.
  • Female patients of childbearing age must undergo two pregnancy tests in the doctor’s office to confirm that they aren’t pregnant before starting an Accutane prescription.
  • Patients must take monthly pregnancy tests in the doctor’s office before each refill and the results are entered into the iPLEDGE system. You must purchase pills within seven days of taking the pregnancy test.
  • Women must also agree to use two forms of birth control while using Accutane, and must self-register on iPLEDGE to report their birth control usage.
  • Pharmacists must check the iPLEDGE database before filling Accutane prescriptions to ensure patients are following the rules. Pharmacies that violate these rules will have their drug supplies cut.

The new Accutane guidelines take effect December 31. Patients can enroll by phone at (866) 495-0654.

To learn more about Accutane, visit our Accutane Legal Center.

Please note: All of our lawyers are licensed to practice in the state of Pennsylvania. We also have lawyers licensed to practice in Ohio, and West Virginia and we associate with experienced attorneys in other states. In addition, all drug-related litigation involves co-counsel.

Source: “FDA curbs acne medicine, requiring a registry.” By Lauran Neegaard. The Associated Press. August 13, 2005.
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