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Accutane (isotretinoin) - Association with Cases of Severe Skin Reactions - For Health Professionals
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(PDF Version - 79 K)Contact: Marketed Health Products Directorate (MHPD)
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This is duplicated text of a letter from Hoffmann-La Roche Limited.
Contact the company for a copy of any references, attachments or enclosures.
Health Canada Endorsed Important Safety Information on ACCUTANE ROCHE (isotretinoin)
February 11, 2010
Subject: Association of ACCUTANE™ ROCHE® (isotretinoin) with cases of severe skin reactions
Dear Health Care Professional,
Hoffmann-La Roche Limited, in consultation with Health Canada, would like to inform prescribers of important new safety information regarding the use of ACCUTANE™ ROCHE ® (isotretinoin).
ACCUTANE is a retinoid indicated for the treatment of severe nodular and/or inflammatory acne, acne conglobata and recalcitrant acne.
- There have been very rare post-marketing reports of severe skin reactions (e.g. erythema multiforme [EM], Stevens-Johnson syndrome [SJS], and toxic epidermal necrolysis [TEN]) associated with ACCUTANE use.
- These events may be serious and result in hospitalization, disability or death.
- Patients should be monitored closely for severe skin reactions and discontinuation of ACCUTANE should be considered if warranted.
Over the past 25 years, ACCUTANE has been prescribed worldwide to approximately 16 million patients.
Based on a review of the Roche global safety database (as of November 6, 2009), 66 cases of severe skin reactions (e.g. erythema multiforme [EM], Stevens-Johnson syndrome [SJS], and toxic epidermal necrolysis [TEN]) in adults and children have been reported worldwide in association with ACCUTANE. Two of the cases were fatal. While there are confounding factors for the majority of the reports received, a causal association between ACCUTANE and these severe skin reactions cannot be excluded.
The ACCUTANE Canadian Product Monograph will be updated with the above mentioned safety information.
Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious cutaneous reactions or other serious or unexpected adverse reactions in patients receiving ACCUTANE should be reported to Hoffmann-La Roche Limited or Health Canada at the following addresses:
Drug Safety Department
2455 Meadowpine Boulevard
Mississauga, Ontario, L5N 6L7
or call toll free at: 1-888-762-4388
or Fax at: 905-542-5864
or email to: mississauga.drug_safety@roche.com
Any suspected adverse reaction can also be reported to:
Canada Vigilance Program
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701D
Ottawa, Ontario, K1A 0K9
Telephone: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Telephone: 1-866-234-2345
Fax: 1-866-678-6789
CanadaVigilance@hc-sc.gc.ca
The Adverse Reaction Reporting Form and the Adverse Reaction Guidelines can be found on the Health Canada Web site or in the Canadian Compendium of Pharmaceuticals and Specialties.
For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738
Should you have any questions or require additional information regarding the use of ACCUTANE, please contact the Drug Information Department at Hoffmann-La Roche Limited at 1-888-762-4388 from 8:30 a.m. to 4:30 p.m. Monday to Friday Eastern Standard Time.
Sincerely,
original signed by
Lorenzo Biondi,
Vice President, Medical and Regulatory Affairs
Hoffmann-La Roche Limited
