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Important Safety Information on ACCUTANE - Hoffman La Roche Limited, Canada

Date: 2001-03-30

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BGIVD Enquiries

March 2001

IMPORTANT SAFETY INFORMATION ON ACCUTANE

Dear Doctor,

There have been an increasing number of reports which suggest a temporal association between Accutane^TM Roche^® (isotretinoin) and the occurrence of depression and/or suicidal ideation in young people. Roche has a strong interest in the safest possible administration of 'Accutane' and therefore has worked diligently with the Therapeutic Product Directorate of Health Canada to reinforce the safety information in the PRODUCT MONOGRAPH and to provide additional information to patients.

'Accutane' is indicated for the treatment of severe nodular and/or inflammatory acne conglobata or recalcitrant acne. 'Accutane' should be reserved for patients where the conditions listed above are unresponsive to conventional therapy, including systemic antibiotics.

Psychiatric disorders

The majority of patients with severe acne are young people. Teenagers and young adults are at increased risk of depression, suicidal ideation and suicide.¹
Some young people treated with 'Accutane' have been reported to develop depression, suicidal ideation and, rarely, to commit suicide. Depression has been reported during and after therapy. In some of these patients, depression has subsided with discontinuation of therapy and recurred when 'Accutane' therapy was re-introduced. Although a causal relationship has not been definitely established at this time, all patients should be screened, monitored for signs of depression during therapy, and particular care should be taken in patients with a personal or family history of depression. If symptoms of depression develop or worsen during treatment with 'Accutane,' the drug should be discontinued promptly and the patient referred for appropriate psychiatric treatment as necessary.

Contraceptive counselling - prior to therapy with Accutane

Accutane^TM Roche^® is a teratogen, and all female patients of childbearing potential must be counselled prior to and throughout therapy. Should you not already have a copy of the Pregnancy Prevention Program,^© please call 1-877-882-2263 ext. 101 to order. Patients must use effective contraception for one month before beginning 'Accutane' therapy, during, and one month following discontinuation of therapy. Note that "effective" contraception is defined as two reliable forms of contraception used simultaneously, unless abstinence is the chosen method. Two negative pregnancy tests must be obtained prior to start of therapy. A monthly assessment of the patient should be performed. A negative pregnancy test must be obtained before each prescription renewal is issued (see chart in the Information for the Consumer).

Patient education materials must be used in all health care provider discussions with patients to assure the safe and effective use of 'Accutane'. The following materials are available:

The Pregnancy Prevention Program (which includes a handout for all female 'Accutane' patients) and the Accutane Treatment Checklist, Accutane Informed Consent form and Information for the Consumer. To order these materials call toll-free 1-877-882-2263 ext. 101.

Please regularly consult the 'Accutane' PRODUCT MONOGRAPH for complete information on prescribing 'Accutane' ( www.rochecanada.com).

If you have any questions about 'Accutane,' please call the toll-free number for Roche Drug Information at 1-888-762-4388.

If you are aware of any serious Adverse Events in association with the use of 'Accutane', report such information to Roche at the above number or to Health Canada, National Adverse Drug Reaction Unit at 613-957-0337 or fax to 613-957-0335 or e-mail: cadrmp@hc-sc.ga.ca

Sincerely,

Pierre Geoffroy
Medical Director
Hoffmann-La Roche Ltd.

Attachment : Revised Information for the Consumer and Informed Consent Form