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ABOUT ACCUTANE

Accutane (a brand of isotretinoin) is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics. However, Accutane can cause serious side effects, including depression and suicidal thoughts. A recent study reported in the American Journal of Psychiatry suggests that isotretinoin treatment is associated with changes in brain function.

The U.S. Food and Drug Administration (FDA) changed its rules regarding Accutane and now requires doctors to get patients to sign a consent form. The form is produced by Accutane's maker, Hoffman-LaRoche. 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. Accutane is one of just three drugs in the United States that has ever been required to come with a Medguide. The FDA also requires doctors and pharmacists to notify the agency immediately if a patient becomes pregnant while taking Accutane.

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DRUG RISK NEWS HEADLINES

May 2005 - FDA Alert....

November 23, 2004 - Accutane Info....


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