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Accutane (isotretinoin) - Association with Cases of Severe Skin Reactions - For the Public
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(PDF Version - 46 K)Contact: Marketed Health Products Directorate
The Health Products and Food Branch (HPFB) posts on the Health Canada Web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from Hoffmann-La Roche Limited.
Contact the company for a copy of any references, attachments or enclosures.
Public Communication
Health Canada Endorsed Important Safety Information on ACCUTANE ROCHE (isotretinoin)
February 16, 2010
Subject: Association of ACCUTANE™ ROCHE® (isotretinoin) with cases of severe skin reactions
Hoffmann-La Roche Limited, in consultation with Health Canada, would like to inform you of important new safety information regarding the use of ACCUTANE™ ROCHE® (isotretinoin).
ACCUTANE is a medicine used to treat severe acne (nodular and/or inflammatory) that cannot be cleared up by other acne treatments, including antibiotics. Acne is a skin condition mainly affecting adolescents with lesions (pimples, cysts, nodules) appearing most often on the face, chest and back.
- There have been very rare reports of severe skin reactions associated with the use of ACCUTANE. These events may be serious in nature and can result in hospitalization, disability or death.
- If you are taking or have recently been taking ACCUTANE and you develop any of the following:
- rash, especially if associated with fever and/or malaise or conjunctivitis (red or inflamed eyes, like "pink eye");
- blisters on legs, arms or face and/or sores in mouth, throat, nose or eyes;
- peeling skin,
stop ACCUTANE and see a doctor immediately.
- Severe skin reactions can start with mild non-specific symptoms such as fever, malaise, chills, aching muscles, headache, sore throat or stinging eyes. It can take up to 3 days for the skin lesions to develop.
Over the past 25 years, ACCUTANE has been prescribed worldwide to approximately 16 million patients. A total of 66 cases of severe skin reactions (e.g. erythema multiforme [EM], Stevens-Johnson syndrome [SJS] and toxic epidermal necrolysis [TEN]) have been reported in both adults and children worldwide. While there were other factors involved for the majority of these reports, an association between ACCUTANE and these severe skin reactions cannot be ruled out.
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 skin 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
