Warning About Acne Drug, Accutane

March 2007

Are you taking Accutane, also known as isotretinoin, to control severe acne? The Food and Drug Administration (FDA) warns buyers from purchasing isotretinoin over the Internet. The drug, known under its brand name, Accutane, also is sold under the generic names of Amnesteem, Claravis, and Sotret.

Side effects may include blurred vision, diarrhea, dizziness, headaches, muscle weakness, nausea, vomiting, seizures, and stroke. The most notable dangers of isotretinoin are serious mental health issues such as suicide and depression, along with extremely high risks for pregnant women, such as birth defects.

The FDA determined that the dangers posed by the medication are so great that all physicians, pharmacies, and distributors must register with a program known as iPLEDGE. Accutane and its generic variations are only legally available by prescription from doctors and pharmacies registered with the program.