Important Safety Information on FLUOTIC (sodium fluoride) 20 mg tablets - For Health Professionals

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June 21, 2007

Subject: Voluntary Recall of One Lot of Fluotic® (sodium fluoride) 20 mg tablets and Notice of Product Discontinuation

Dear Health Care Professional,

This letter is to inform you that sanofi-aventis Canada Inc., with agreement from Health Canada, has undertaken a voluntary recall of one lot of Fluotic^® (sodium fluoride) 20 mg tablets, bottle of 100: lot number 8034613 (expiry date: September 2008). This voluntary recall is intended to address a quality issue. In in-vitro tests, the disintegration time of some tested samples in gastric fluid-like solution was faster than usual. Although the product is not likely to cause any adverse health consequences to the patient, there is potential risk that an early disintegration of sodium fluoride in the gastric environment may increase the risk of gastric toxicity such as gastric irritation, risk of bleeding or gastric ulcer.

While the overall risk to the patient is considered to be low, sanofi-aventis Canada Inc. has decided to recall the above lot of Fluotic^® at the wholesaler, distributor and pharmacist levels as of June 1, 2007. As a result, there is currently a shortage of Fluotic^® at these levels.

As well, following an annual review of our product line and due to the very limited use of the product, sanofi-aventis Canada Inc. also took the decision to discontinue, in June 2007, the marketing of Fluotic^® (sodium fluoride), 20 mg tablets, which is approved for the treatment of otospongiosis.

Sanofi-aventis remains committed to the health and well being of patients. This voluntary recall is conducted with the knowledge of the Health Products and Food Branch Inspectorate of Health Canada.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. As always, any case of serious or unexpected adverse reactions in patients using Fluotic^® should be reported to sanofi-aventis Canada Inc. or Health Canada at the following addresses:

Sincerely,

original signed by

Franca Mancino, M.Sc.
Senior Director, Regulatory Affairs and Pharmacovigilance