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U.S. Department of Health and Human Services

Safety

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Accutane (isotretinoin) Feb 2001

Manufacturer releasing two new communication tools for this acne treatment: a Medication Guide and an Informed Consent for all Accutane patients.
[January 22, 2001 - Letter - Roche Laboratories, Inc.]
[January 22, 2001 - Informed Consent/Patient Agreement - Roche Laboratories, Inc.]

  • Supplements consent form in Accutane Label, May 2000

[September 2000 (Advisory Committee Meeting Briefings)

  • Background info on pregnancy, psychiatric events risk management issues.