Advisory

2003-53
July 7, 2003
For immediate release

Health Canada advises public of counterfeit Lipitor^® in U.S.

OTTAWA - Health Canada is advising consumers about reports in the U.S. of counterfeit Lipitor^®, a cholesterol-lowering drug. These counterfeit drugs are identifiable by packaging and labelling that states the product has been repackaged by the company MED-PRO.

On May 26, 2003, Pfizer Canada Inc., the manufacturer of Lipitor^® for the Canadian market, issued a notice to Canadian pharmacies, drug wholesalers and pharmacy associations informing them of this matter. The company states they have received no information or complaints to indicate any counterfeit Lipitor^® has been distributed in Canada.

As a precaution, Health Canada is issuing this advisory to alert consumers, health care professionals, and the provincial Ministries of Health to this matter as well as to the potential safety issues related to the use of the counterfeit Lipitor^® tablets.

On May 23, 2003, the U.S. Food and Drug Administration (FDA) issued its first alert on counterfeit Lipitor^®, advising of specific lots of the drug being counterfeit. The FDA has subsequently issued a broader alert on June 3, 2003 advising that all Lipitor^® drugs are counterfeit if they contain packaging or labelling that states: "Repackaged by: Med-Pro, Inc., Lexington, Neb 68850". The discovery of the counterfeit Lipitor^® has resulted in Albers Medical Distributors Inc., of Kansas City, MO. as well as H.D. Smith Wholesale Drug Co., of Springfield, Ill. to recall all Lipitor^® products repackaged by MED-PRO.

Consumers in Canada are advised to check the packaging and label very carefully before using Lipitor^®. Consumers who have any of the product stating "Repackaged by: MED-PRO, INC. Lexington, NE 68850" should not use the product and return the bottle to the pharmacy where it was purchased. Consumers who do not have the product in its original packaging should contact their pharmacist. Sometimes, pharmacists will put medications in dosettes (especially for elderly people, a common target for lipid-lowering medications), which is a container for pills with compartments labelled 'AM, PM, evening' as a reminder and a preventive measure against double-dosing.

If any bottles of the counterfeit Lipitor^® are found in Canada, individuals and health professionals are asked to also contact the closest Health Products and Food Branch Inspectorate Operational Centre at the numbers listed below.

The counterfeit pills are reportedly slightly thicker than the authentic Lipitor^® tablets, dissolve more quickly and have a bitter taste.

On June 17, 2003, the FDA also announced that its Forensic chemistry centre in Cincinnati Ohio determined that the counterfeit tablets tested to date do contain atorvastatin, the active ingredient in Lipitor^®. However, the effectiveness of the product has not been established. The Forensic Chemistry Centre's analysis to date has not identified any known harmful substances in the counterfeit tablets, although analytical testing continues. The fake Lipitor^® pills contain up to 10% of an unknown substance. The effectiveness of these counterfeit pills is unknown and they are unlikely to help lower cholesterol.

Consumers should consult with their pharmacist and their physician if they have experienced any adverse effects from taking Lipitor^® (or atorvastatin - the active ingredient in Lipitor^®). Health Canada also encourages health care professionals and consumers to report any suspected adverse events associated with the use of a product to the following address:

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

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Media Inquiries:
Ryan Baker
Health Canada
(613) 954-4807

Health Products and Food Branch Inspectorate Operational Centres