Excipient problem leads to Coumadin recall
pharmafile | July 20, 2010 | News story | Manufacturing and Production |Â Â BMS, manufacturing compliance, recallsÂ
Bristol-Myers Squibb is recalling nearly 150,000 tablets of its anticoagulant product Coumadin distributed across the US because some of them may be out-of specification.
In a statement BMS said that some of the tablets may not contain the correct amount of isoporopanol or isopropyl alcohol, an excipient that is used to maintain the active ingredient in Coumadin in the desired crystalline state.
A statement issued by the US Food and Drug Administration (FDA) notes that the defect could affect the therapeutic levels of Coumadin (warfarin sodium), as a decrease in the product’s active ingredient “may increase the risk of clots which could lead to heart attack or stroke”. If there is too much active ingredient the product could also be associated with an increased risk of bleeding, it added.
The recall includes five production lots of Coumadin hospital unit doses and three lots of physician samples, said the FDA. All the tablets were distributed in blister packs of 1mg tablets in 10- and 100-count packs. No bottled medicine or other doses are involved.
A statement released by the company said the recall is a precaution, and no side effects have been reported as yet.
BMS “is committed to ensuring patient safety and is working to resolve this issue quickly and appropriately,” it said.
In addition to BMS’ Coumadin brand there are a number of generic warfarin products available on the US market. The affected lots are a tiny fraction of the warfarin in circulation in the market. It is estimated that up to 2 million people are treated with the anticoagulant each year in the USA.
A list of the recalled lots, which have expiration dates between June 2011 and November 2012, can be found here.
Phil Taylor
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