Bristol-Myers Squibb is recalling one lot of the blood thinner Coumadin because of potential inconsistencies in potency. The company tested tablets from a returned bottle and found that one tablet was more potent than it should have been. The level of active ingredient in a tablet is obviously key to a blood thinner's effectiveness; too little and the risk of clots increases, but too much and the risk of bleeding grows.
In its announcement, the FDA advised patients with 5-mg tablets to ask their pharmacists whether their prescription was filled from the suspect lot of 1,000-count bottles. If so, they should call their doctors.
As MedPage Today reports, another warfarin product was recalled earlier this year on a dosing problem. Upsher-Smith Laboratories pulled some of its generic warfarin because of the risk that some tablets of varying doses were mixed into the same bottles. One bottle labeled as 3-mg tablets mistakenly contained some 10-mg tablets.
- see the FDA release
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