Drugmaker recalls samples of antiplatelet drug

AstraZeneca has voluntarily recalled 1 lot of physician-sample bottles of ticagrelor (Brilinta) 90-mg tablets as a precaution.

As of May 24, the manufacturer has not received any reports of adverse events.

The recall affects Lot #JB5047 of sample bottles that were distributed to physicians in the United States between March and April 2017. The nationwide recall is due to a report that the sample bottles contained Brilinta and lesinurad (Zurampic, AstraZeneca) 200-mg tablets, which is used to treat gout.

Other forms and dosage strengths of Brilinta, including medication obtained via United States retail or mail order pharmacies, are not affected by the recall. Additionally, the recall does not affect Zurampic.

Brilinta is an antiplatelet agent indicated to reduce the rate of cardiovascular death, myocardial infarction and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction. The medication is also used to reduce the rate of stent thrombosis in patients who have been stented for treatment of ACS. Missed doses of Brilinta increase the risk of heart attack and stroke. Patients who are treated with a stent and miss doses of Brilinta have a higher risk of forming a blood clot in the stent, having a heart attack, or even death.  

Zurampic is a uric acid transport inhibitor used together with a xanthine oxidase inhibitor, such as allopurinol or febuxostat (Uloric, Takeda) in adults with gout who still have a high uric acid level. Unintentional dosing with Zurampic has the potential to lead to adverse renal effects including acute renal failure which is more common when the medication is given alone instead of in combination with a xanthine oxidase inhibitor as indicated.

Brilinta 90-mg tablets are supplied as round, biconvex, yellow, film-coated tablets, and imprinted with "90" above a "T" on one side of the pill. Zurampic 200-mg tablets are blue, elliptical/oval shaped tablets imprinted with "LES200" on one side of the pill.

AstraZeneca is notifying physicians by recall letter and is arranging for return of all recalled products. Consumers that have the medications being recalled are instructed to contact their physician.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to FDA’s MedWatch Safety Information and Adverse Event Reporting Program. To do this, individuals can complete and submit the report online at www.fda.gov/MedWatch/report or call (800) 332-1088 to request a reporting form. Once complete, the form should be returned to the address on the pre-addressed form or faxed to (800) FDA-0178.