FDA announces recall of platelet-reducing medication due to risk of clotting or other adverse cardiovascular outcomes

Teva Pharmaceuticals USA, a New Jersey-based healthcare company focused on the development and distribution of generic medications, has recalled a single lot of its anagrelide capsules due to a failed dissolution test.

Anagrelide is a platelet-reducing agent indicated for the treatment of thrombocythemia. It lowers the patient’s risk of thrombosis and can limit the impact of certain symptoms related to thrombo-hemorrhagic events.

This is a voluntary recall. No complaints or adverse events have been reported thus far, but the failed dissolution test does mean patients could face certain risks if they took any of the impacted capsules.

“Administration of this product with lower dissolution — taking longer to dissolve once ingested — may result in decreased effectiveness or ineffectiveness of the drug to exert its platelet-reducing effect,” according to an advisory from the U.S. Food and Drug Administration (FDA). “Failed dissolution can result in a slower rate and extent of drug release leading to less anagrelide available in the body. For seriously ill patients with elevated platelet counts, less available anagrelide in the body could increase the risk of clotting, and coagulation or bleeding events such as a heart attack or stroke, which could be life threatening.”