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Bristol-Myers Recalling Blood Pressure Drug Avalide

January 14, 2011

Bristol-Myers Squibb Co said Thursday that it is recalling 64 million tablets of the blood pressure medicine Avalide in the U.S. and Puerto Rico due to the potential for reduced effectiveness.

The move marked the second major recall in less than four months of the medicine co-marketed with French drugmaker Sanofi-Aventis.

Bristol-Myers recalled 62 lots, or 60 million tablets, of the drug manufactured in Puerto Rico.  The company said that the new recall involved 65 lots of Avalide manufactured in plants in Humacal, Puerto Rico and Evansville, Indiana.

Avalide is a combination pill comprised of the drugs irbesartan, which is sold under the name Avapro, and hydrochlorothiazide, a generic diuretic.

Bristol-Myers reported that for the first nine months of 2010, combined worldwide sales of Avalide and Avapro totaled $924 million.

Bristol-Myers said that the recall was not announced publicly but communicated via letters to wholesalers and healthcare professionals.

The problem detected was the same that led to the previous recall, a potential variability in levels of the less-soluble form of the active ingredient irbesartan.

Bristol-Myers spokeswoman Christina Trank told Reuters that as with the September recall, the problem suggests the possibility of reduced efficacy, although the company has not turned up evidence of reduced effectiveness, nor have there been any reports of safety problems or patient harm.

The affected Avalide doses were 150/12.5 milligrams, 300/12.5 mg, 300/25 mg and blister sample packs of 300/25 mg. 

The company said that the recall did not involve stand-alone Avapro.

Trank said the company had developed more sensitive testing methods to detect a less soluble form of the active ingredient and the new testing revealed the need for a further recall.

Trank said that patients who have purchased Avalide from the recalled lots can contact their prescribing doctor, pharmacy or Bristol-Myers customer relations.

Manufacturing irregularities and product recalls have become an increasingly high profile problem for the drug industry.

Johnson & Johnson has found a series of massive recalls that has taken some of its best known consumer products like Tylenol, Motrin and Rolaids off the pharmacy shelves.

GlaxoSmithKline paid $750 million in civil and criminal penalties for selling contaminated, adulterated and ineffective drugs produced at a now closed plant in Puerto Rico.

Other drugmakers recalled medicines after finding foreign particles like metal, glass and insect parts in their drugs.

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