GW501516 - Serious Risks Associated With the Use of the Unauthorized Product - For the Public

Starting date:
May 24, 2013
Posting date:
May 24, 2013
Type of communication:
Public Communication
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public
Identification number:
RA-33605

This is duplicated text of a letter from GlaxoSmithKline Inc. 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 An Unauthorized Product called GW501516

May 24, 2013

Subject: Serious risks associated with use of the unauthorized product GW501516

GlaxoSmithKline Inc. (GSK), in consultation with Health Canada, would like to inform you that a compound referred to as GW501516 is being made available for sale to Canadians via the internet. This compound may be abused by some athletes for performance enhancement. It is not known if the product available via the internet and sold as GW501516 is actually GW501516 or another compound.

GW501516 is not approved for use in humans and has never been manufactured nor distributed by GSK. GW501516 was being developed to raise HDL or “good” cholesterol in patients with abnormal cholesterol levels in their blood. In 2006, GSK stopped clinical development of GW501516 when toxicities, including a variety of cancers, were discovered following routine, long term animal studies.

  • An unauthorized product, known as GW501516, is being made available on the internet.
  • All clinical development of GW501516 was stopped when toxicities, including various cancers, were discovered following routine, long term animal studies. The long-term effects of GW501516 in humans are unknown.
  • Canadians are advised not to use this product under any circumstances and should consult with a health care professional if they have concerns about their health related to its use.
  • GW501516 is not approved for use in humans. GSK does not manufacture or authorize its sale.

In 2011, GSK signed an agreement with the World Anti-Doping Agency (WADA) to supply confidential information about medicines in early stage development that could be abused by athletes once they are licensed for patient use. GW501516 was one such investigational compound that GSK provided information about to WADA. During preclinical animal safety studies of this experimental medicine, it was found to cause toxicities in mice and rats. All further development of GW501516 was stopped and these findings were reported to regulatory authorities and presented at a scientific meeting and published1. GW501516 has been on the WADA Prohibited List for several years and this action was independent of GSK.

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find GW501516 in the Canadian marketplace.

For media inquiries, please contact GlaxoSmithKline Communications at (905) 819-3363.

Managing product-related side effects depends on health care professionals and consumers reporting them. Any serious side effects in patients who have used GW501516 should be reported to GlaxoSmithKline or Health Canada.

GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Tel: 1-800-387-7374

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:
Health Product and Food Branch Inspectorate
E-mail: DCVIU_UVECM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 1-613-946-5636

Sincerely,

original signed by

Dr. Glenn Crater,
Vice-President, Medical and Chief Medical Officer
GlaxoSmithKline Inc.

References:

  1. Supplement to Toxicological Sciences, 2009, 108(1) p185