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Bristol-Myers Squibb Co. (BMY-N) is recalling 60 million tablets of the blood pressure medication Avalide in the United States and Puerto Rico.
The company said it took the action on behalf of the Bristol-Myers Squibb/Sanofi-Synthelabo partnership because of a potential variability in levels of the less-soluble form of the active ingredient in Avalide, irbesartan, which could result in slower dissolution.
Bristol-Myers said 62 lots, or 60 million tablets, manufactured before November 2009 at its plant in Puerto Rico were affected by the recall.
Avalide is comprised of the drugs irbesartan and hydrochlorothiazide. The recalled tablets contain 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
In a statement, the company said "a thorough review of the global post-marketing safety database has not revealed evidence of a signal suggesting reduced efficacy. However we cannot definitively exclude this possibility."
"Other than the potential for an impact on the anticipated blood pressure lowering efficacy, we are not aware of any other risk to patients who may have taken product from these lots," added company spokeswoman Christina Trank.
Other lots of Avalide 300/25 mg, as well as other dosage strengths of both Avalide and Avapro, or irbesartan, are not affected, and no interruption in supply is anticipated, the company said.
Bristol-Myers Squibb reported worldwide sales of Avalide and Avapro of $307 million US for the first half of 2010, which was down 2 percent from the 2009 period.
Dr. Micah Eimer, a cardiologist in suburban Chicago, said he has not had reports of adverse events from his patients, but noted that it is sometimes difficult to determine the cause of a problem.
"Some patients are on two, three, four or more medications, so what's the pharmacological effect on each drug? It's not easy to say. If the effect (of the drug) isn't predictable, if (the drug strength) is too high or too low, it can affect kidney function, potassium levels, sodium, all sort of things," he said.
"There could be a wide range of effects if the drug isn't predictable."