February 1998

Dear Doctor:

Please be advised of important changes to the prescribing information for Accutane (isotretinoin).

The information pertaining to Adverse Experience reports of depression, which has appeared in the ADVERSE REACTIONS section of the prescribing information, will now also appear in the WARNINGS section. The following revisions will be made:

• the WARNINGS section will now begin with the following paragraph in bold type:

  "Psychiatric disorders: Accutane may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts and suicide. Discontinuation of Accutane therapy may be insufficient; further evaluation may be necessary. No mechanism of action has been established for these events."

• the paragraph on depression in the ADVERSE REACTIONS section will become paragraph 5 of that section and will be revised as follows:

  "In the post-marketing period, a number of patients treated with Accutane have reported depression, psychosis and, rarely, suicide ideation, suicide attempts and suicide. Of the patients reporting depression, some reported that the depression subsided with discontinuation of therapy and recurred with reinstitution of therapy."

It is important to note that reports of these Adverse Experiences are uncommon but, because of their potential consequences, clinicians should be attentive to any new behavioral signs and symptoms.

Please consult the revised complete product information for Accutane, which is enclosed. If you have any questions about Accutane, we encourage you to call the the toll-free number for Roche Medical Services at 1-800-526-6367. Also, if you are aware of any serious Adverse Experiences potentially associated with the use of Accutane, please report such information to Roche at the above number or to the Food and Drug Administration MedWatch program at 1-800-FDA-1088.

Sincerely,

Russell H. Ellison, M.D.
Vice President
Medical Affairs

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