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The impacted lot failed a dissolution test, meaning it was taking longer to dissolve once ingested. This can result in less anagrelide available in the body, possibly leading to clotting or bleeding events such as a heart attack or stroke.
Teva Pharmaceuticals has initiated a voluntary nationwide recall of a single lot of anagrelide capsules, 0.5 mg. This recall was initiated due to dissolution test failure detected during routine stability testing. No other lots are impacted.
Anagrelide is used to decrease the number of platelets and is indicated to treat patients with thrombocythemia (a condition in which the body makes too many platelets), secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events
Taking longer to dissolve once ingested may result in decreased effectiveness or ineffectiveness of the drug to exert its platelet-reducing effect. 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 (blood coagulation), and clotting or bleeding events such as a heart attack or stroke, which could be life threatening
Teva has not received any reports of adverse events.
The effect lot is GD01090 and has an expiration date of May 2022.