FDA MedWatch - One Lot of Anagrelide Capsules - USP 0.5 mg by Teva:

Recall - Due to Dissolution Test Failure

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: One Lot of Anagrelide Capsules - USP 0.5 mg by Teva: Recall - Due to Dissolution Test Failure AUDIENCE: Patient, Health Professional, Risk Manager, Cardiology, Hematology, Pharmacy ISSUE: Teva Pharmaceuticals is recalling of a single lot of Anagrelide capsules - USP 0.5 mg (Lot number GD01090) due to dissolution test failure detected during routine stability testing. No other lots are impacted. 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. 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. To date, Teva has not received any product quality complaints or adverse event reports, of this nature, for the recalled lot. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: Anagrelide capsules are indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events.  RECOMMENDATION:  Consumers with questions or concerns should consult with their health care provider(s). Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178. Follow us on Twitter at @FDAMedWatch

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