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January 22, 2001

Dear Healthcare Provider and Pharmacist,

In an effort to continually improve the risk communication regarding Accutane to all healthcare providers, pharmacists and patients, Roche Laboratories Inc. will be releasing two new Accutane specific communication tools: 1) a Medication Guide for Accutane and, 2) an Informed Consent for all Accutane patients. These documents will be sent this month to prescribers’ offices and to all pharmacies in the United States to further provide information that is necessary to patients’ safe and effective use of Accutane.

The Medication Guide for Accutane is a document that must be distributed by the pharmacist to every Accutane patient each time an Accutane prescription is dispensed. The Medication Guide was developed in conjunction with the FDA to emphasize key safety issues that patients should know about the use of Accutane. This Medication Guide for Accutane summarizes, in very simple language, the Professional Package Insert, including the approved indication for Accutane and major adverse events reported in the package insert. The Medication Guide is a document required by the FDA for specific medications and must be available for every patient.

The Informed Consent for Accutane is also a newly revised document that is to be completed and signed by each Accutane patient before receiving Accutane. After the prescriber has determined that a patient may be a candidate for Accutane, and has explained the proper use of this medication and the possible side effects the patient may experience, the patient must initial each of the 15 items and sign and date the entire informed consent. The prescriber is also to sign this document. Additionally, female patients will be required to initial and sign the informed consent that is currently a component of the Pregnancy Prevention Program^SM and included in the Professional Package Insert. The signed and dated documents remain with the patient’s medical records. In simple language, the Informed Consent documents reinforce the benefits and risks of taking Accutane.

These new documents supplement other patient education materials provided by Roche, such as Important Information Concerning Your Treatment with Accutane^® (isotretinoin) –7^th Edition (patient’s brochure). Patient education materials are intended to be used in all prescriber discussions with patients to further provide information that is necessary to patients’ safe and effective use of Accutane.

If you have any questions about Accutane or these new communication tools, please call the toll-free number for Roche Medical Services at 1-800-526-6367. Also, if you are aware of any serious Adverse Events potentially associated with the use of Accutane, report such information to Roche at the above number or to the Food and Drug Administration MedWatch program at 1-800-FDA-1088 or FDA Office of Emergency Operations at (301) 443-1240 or https://www.accessdata.fda.gov/scripts/medwatch/

Sincerely,

Joseph Hong, MD
Medical Director for Accutane
Roche Laboratories
340 Kingsland Street
Nutley, NJ 07110

Attachments:
Professional Package Insert
Medication Guide for Accutane
Informed Consent for Accutane Patients

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