Avalide Recall Issued Due to Risk of Reduced Effectiveness

Bristol-Myers Squibb has issued a recall for Avalide, which impacts about 64 million tablets of the blood pressure medicine due to concerns that they may not release enough of one of the active ingredients.  

The Avalide recall was announced to wholesalers and healthcare professionals through letters sent out by Bristol-Myers Squibb and has not yet been publicly announced. The recall is taking place due to the risk of reduced effectiveness.

Avalide is a combination of hydrochlorothiazide (HCT) and irbesartan, which is sold separately under the brand name of Avapro. Avalide sales brought in $310 million in the first nine months of 2010.

In July, the FDA launched a safety review of Avapro and similar blood pressure drugs, due to concerns over an increased risk of cancer.

A recall of Avalide is being issued because the irbesartan is less soluble than it should be in certain batches. That means that the pill will not dissolve properly in the stomach and the correct amount of irbesartan may not be released from the pill. The same problem led to a recall of 60 million Avalide tablets in September. In neither case have there been any reports of injury or illness due to the defective pills.

The recall affects 150/12/5 milligram (mg), 300/12/5 mg, and 300/25 mg doses of Avilade. The affected pills were sold in the U.S., Puerto Rico, Canada, Mexico and Argentina.

While Bristol attempts to resolve the problem, production of Avalide will be halted. In the interim, the company is offering vouchers to allow patients to be able to purchase Avapro and HCT as separate drugs. The vouchers will allegedly defray the cost of the HCT.

On the Avalide and Avapro webpage, a pop-up alert warns that there will be a shortage of Avalide and recommends that physicians prescribe Avapro and HCT. However, it does not mention an Avalide recall. The alert claims that, with the voucher, the two medications will cost a total of about $20 a month. Any consumers with questions are advised to call 1-800-332-2056 or 1-800-321-1135.