MedWatch - Accutane (isotretinoin) Dear Accutane Prescriber letter

2002 Safety Alert - Accutane (isotretinoin)

This is the retyped text of a letter from Roche Laboratories. Contact the company for a copy of any referenced enclosures.

Dear Accutane Prescriber,

Roche Laboratories would like to advise you of several recent changes to the Accutane Package Insert.

These changes involve the following sections:

1 ) Professional labeling WARNINGS: Psychiatric Disorders, and related sections in patient labeling

2) Pediatric Labeling, professional and patient

3) Boxed CONTRAINDICATIONS AND WARNINGS in professional labeling regarding pregnancy testing

WARNINGS: Psychiatric

Disorders
Aggressive and/or violent behaviors have been added to the list of events that Accutane may cause, based on post-marketing safety reports. No mechanism of action has been established for these events. This information has also been added to the section entitled ADVERSE EVENTS: Psychiatric. Related wording has been added to appropriate sections of the patient Medication Guide and Informed Consent form.

Pediatric Labeling
Information specific to pediatric patients has been added to the Accutane Package Insert based on the results of recent studies conducted in this patient population. This information is found in the following sections, with related wording in appropriate sections of the patient labeling:

CLINICAL PHARMACOLOGY: Special Patient Populations: Pediatric Patients

WARNINGS: Skeletal: Bone Mineral Density

PRECAUTIONS: Pediatric Use:

A new section entitled "General " has been added under PRECAUTIONS to advise you to use caution when prescribing Accutane to patients with a genetic predisposition for age-related osteoporosis, a history of childhood osteoporosis conditions, osteomalacia, or other disorders of bone metabolism.

This section also advises you that your patients may be at increased risk when participating in sports with repetitive impact.
Information for Patients and Prescribers notes that 29% of pediatric patients treated with Accutane in the studies developed back pain and 22% experienced arthralgias.
Information regarding the use of "Systemic Corticosteroids " was added to the Drug Interactions section of PRECAUTIONS and additional information was added under "Phenytoin. " Both sections advise you to exercise caution when these drugs are used with Accutane.

DOSAGE AND ADMINISTRATION: A statement has been added regarding the long-term use of Accutane as well as a statement advising that Accutane be given at the recommended doses for no longer than the recommended duration.

Boxed CONTRAINDICATIONS AND WARNINGS in Professional labeling: pregnancy testing

In the boxed CONTRAINDICATIONS AND WARNINGS, a new table has been added to clarify those circumstances where pregnancy tests and Accutane Qualification Stickers are applicable.

Table 1. Use of Pregnancy Tests and Accutane Qualification Stickers for Patients
Patient Type	Pregnancy Test Required	Qualification Date	Accutane Qualification Sticker Necessary	Dispense Within 7 Days of Qualification Date
All Males	No	Date Prescription Written	Yes	Yes
Females of Childbearing Potential	Yes	Date of Confirmatory Negative Pregnancy Test	Yes	Yes
Females* Not of Childbearing Potential	No	Date Prescription Written	Yes	Yes
*Females who have had a hysterectomy or who are postmenopausal are not considered to be of childbearing potential.

Please refer to the enclosed complete updated product information for detailed information on the boxed contraindications and warnings, warnings, precautions, adverse reactions, and dosage and administration.

If you have any questions or would like to receive additional information on Accutane, please feel free to contact your Roche Laboratories' sales representative or call 1-800-526-6367.

Sincerely,

Ronald Gottschalk, MD
Medical Director, Dermatology
Roche Laboratories Inc.
Enclosures

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