FDA Warnings On Accutane (New Restrictions)
The FDA has changed its rules regarding the drug so that doctors must now get patients to sign a consent form. The form is produced by Accutane's maker, Roche Pharmaceuticals. It says the patient understands all the risks associated with Accutane, including depression and suicide.
Pharmacists must also hand out a detailed warning brochure from the FDA, called a Medguide (below). Accutane is one of just three drugs in the United States that has ever been required to come with a Medguide.