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Serious liver and skin toxicity in HIV uninfected individuals post-exposure prophylaxis
Date: 2001-02-26
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The Therapeutic Products Directorate (TPD) posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers, and other interested parties. Although TPD approves therapeutic products, TPD does not endorse either the product or the company. Any questions regarding product information should be discussed with your health care professional.
Contact the company for a copy of any referenced
enclosures.
NOTICE TO HOSPITALS
from the
Therapeutic Products Directorate
Serious liver and skin toxicity in HIV uninfected individuals post-exposure prophylaxis
February 26, 2001
To: Hospital Chief of Medical Staff
Please distribute to prescribing and dispensing health professionals within
your institution.
The Therapeutic Products Directorate (TPD) wishes to draw your attention to recent publications 1, 2,3 identifying an association in HIV-uninfected individuals receiving multiple doses of VIRAMUNE in the setting of post-exposure prophylaxis (PEP) and serious liver and skin toxicity.
Revised safety information was added to the Canadian Product Monograph for VIRAMUNE (nevirapine), a non-nucleoside analog indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents, December 29, 2000. Existing warnings in the Product Monograph for the risk of serious liver and skin toxicity with VIRAMUNE treatment were strengthened to include serious hepatotoxicity (including liver failure requiring transplantation in one instance) and serious skin rash (including Stevens-Johnson Syndrome) in HIV-uninfected individuals receiving multiple doses of VIRAMUNE in the setting of post-exposure prophylaxis, an unapproved use.
You are referred to the Product Monograph for recommendations regarding the use of VIRAMUNE in the setting of PEP.
References
1 Dear Health Care Professional, Important Drug Warning, Boehringer Ingelheim, Columbus, Ohio, November 2000.
2 Dear Doctor or Pharmacist, Important Drug Warning Boehringer Ingelheim Canada Ltd, November 23, 2000.
3 CDC MMWR Weekly. January 05, 2001 / 49(51); 1153-6, Serious Adverse Events Attributed to Nevirapine Regimens for Postexposure Prophylaxis After HIV Exposures-Worldwide, 1997-2000.
Questions regarding this Notice should be directed to the Bureau of Pharmaceutical Assessment, Therapeutic Products Directorate at (613) 954-6015.
Any suspected adverse reactions can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0201C2 OTTAWA,
Ontario, K1A 1B9
Tel: (613) 957-0337 or
Fax: (613) 957-0335
Toll free for consumers and health professionals: Tel: 866 234-2345,
Fax: 866 678-6789
cadrmp@hc-sc.gc.ca
The AR Reporting Form and the AR
Guidelines can be found on the TPD web site or in The Canadian
Compendium of Pharmaceuticals and Specialties.
