Advisory - Unauthorized drug (Lite Fit USA) being sold in Canada

OTTAWA, May 16, 2014 /CNW/ -

The issue:

One lot of Lite Fit USA (Lot Number 13165, Exp. 05/17) is being voluntarily recalled in the U.S. after analysis by the U.S. Food and Drug Administration revealed the lot contains the undeclared prescription drug sibutramine. Lite Fit USA is not authorized for sale in Canada, but Health Canada has confirmed that this lot was imported and sold by the retail store Hoang Oanh Sandwich, 7178 St. Denis, Montreal, Québec. The affected lot may also be available at other retail outlets or for purchase online. Products that contain sibutramine are not authorized for sale on the Canadian market due to an increased risk of heart attack and stroke.

LiteFit USA is promoted as a herbal diet supplement packaged in plastic bottles of 30 softgels (see photo below).

Who is affected:

Canadians who either have used or purchased Lite Fit USA, lot number 13165.

What consumers should do:

• Read the label of the products you buy to verify that they have been assessed by Health Canada for safety, effectiveness and quality. Health products that have been authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN), a Homeopathic Medicine Number (DIN-HM) or a Natural Product Number (NPN) on the label.

• Contact your health care practitioner if you have any questions or concerns regarding the use of this product.

• Report any adverse events using these products to Health Canada

What Health Canada is doing:

Health Canada is contacting drug importers to prevent any further importation or distribution of Lite Fit USA in Canada. Health Canada is also working with Canada Border Service Agency to help prevent future importations of LiteFit USA.

Background:

Sibutramine was previously used to treat obesity but is no longer authorized for sale in Canada because of its association with an increased risk of cardiovascular side-effects such as heart attack and stroke. The product poses a risk to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of cardiovascular disease including coronary artery disease, congestive heart failure, arrhythmias, or stroke. This product may also cause serious side-effects in pregnant or nursing women. Sibutramine can interact with other medications and herbal products and poses a risk of serotonin syndrome, a serious and potentially fatal event.

Health Canada has not received any adverse reactions reports associated with the use of this product.

Products affected:

1. Lite Fit USA (Lot Number 13165).

For more information:

Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

How to report side effects of health products to Health Canada:

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

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PDF available at: http://stream1.newswire.ca/media/2014/05/16/20140516_C8906_DOC_EN_40459.pdf

SOURCE: Health Canada

Media Enquiries: 
Health Canada
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Public Enquiries:
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1-866 225-0709

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