KETOCONAZOLE - Risk of Potentially Fatal Liver Toxicity - For the Public

Starting date:

June 19, 2013

Posting date:

June 19, 2013

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

General Public

Identification number:

RA-34177

This is duplicated text of a letter from Apotex Inc. and Teva Canada Limited. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Public Communication - Health Canada Endorsed Important Safety Information on KETOCONAZOLE

June 19, 2013

Subject: KETOCONAZOLE and the Risk of potentially Fatal Liver Damage

Apotex Inc. and Teva Canada Limited, in collaboration with Health Canada, would like to inform you of additional safety information regarding the marketed medication KETOCONAZOLE (APO-KETOCONAZOLE and NOVO-KETOCONAZOLE).

KETOCONAZOLE, a medication that treats fungal diseases has been associated with rare cases of liver damage, including cases of death. Liver damage and death may occur in patients with no prior history of liver disease, at recommended doses and in treatment of longer than 10 days.

Information regarding the risk for liver damage has been updated and included in the consumer information document.

• KETOCONAZOLE tablets are prescribed for the treatment of serious or life threatening fungal diseases and should not be used for common and superficial fungal infections.
• KETOCONAZOLE use has been associated with liver damage including cases of death.
• Blood tests to monitor liver function should be done before and during treatment.
• Medical advice should be sought if some of the following signs appear: fatigue, loss of appetite, pain to the stomach, vomiting, and yellow appearance of the skin and of the white portion of the eyes, light colored stool and dark urine. Your physician may test your liver function and may advise to stop your treatment.

Patients who are currently prescribed KETOCONAZOLE should talk to their doctors or healthcare providers if they are taking any other medications, including other products obtained without a prescription or have any questions regarding their treatment.

Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing side effects are generally presumed to underestimate the risks associated with health product treatments. Any case of serious liver toxicity or other serious or unexpected side effects in patients receiving KETOCONAZOLE should be reported to Apotex Inc., Teva Canada Limited or Health Canada.

APOTEX INC.

150 Signet Drive

Weston, Ontario

M9L 1T9
Phone: 1-800-667-4708 Ext: 2
Fax: 1-416-401-3819

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

M1B 2K9
Phone: 1-800-268-4127 Ext. 1255005 (English) or 1-877-777-9117 (French)
Fax:  1-416-355-4472

You can report any suspected side effect associated with the use of health products to Health Canada by:

• Calling toll-free at 1-866-234-2345; or
• Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate

E-mail: mhpd_dpsc.public@hc-sc.gc.ca

Telephone: 613-954-6522

Fax: 613-952-7738

Yours sincerely,

original signed by

Colin D’Cunha

Director, Global Medical Affairs

Apotex Inc.

Bruce Valliant

Director, Medical Affairs

Teva Canada Limited