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News From the Food and Drug Administration
March 7, 2001

New Measures to Manage Risks Associated With Accutane

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JAMA. 2001;285(9):1146. doi:10.1001/jama.285.9.1146

The FDA and Hoffmann-La Roche Inc, Nutley, NJ, have developed a new informed consent form and a medication guide to strengthen protection for patients who use isotretinoin (Accutane) to treat severe recalcitrant nodular acne.

The informed consent form is available from the manufacturer and is to be completed by the patient or the patient's parent or guardian and signed by the health care practitioner. It includes the patient's agreement to fully inform the prescriber about any history of mental depression and to see the practitioner monthly while taking Accutane to renew the prescription and check treatment progress and possible signs of adverse effects.