MedWatch - The FDA Safety Information and Adverse Event Reporting ProgramBrilinta (ticagrelor) 90 mg tablets, 8-count Physician Sample Bottles: Recall of Lot # JB5047 - Due to Report of Another Medicine in One BottleAUDIENCE: Family Practice, Health Professional, Consumers ISSUE: AstraZeneca is notifying physicians and consumers that it is voluntarily recalling one lot of professional (physician) sample bottles containing eight tablets of Brilinta (ticagrelor) 90mg tablets as a precautionary measure. This voluntary recall follows a report that a professional sample bottle containing eight tablets of Brilinta 90mg also contained another medicine called Zurampic (lesinurad) 200 mg tablets which is also manufactured by AstraZeneca. Unintentional dosing with Zurampic has the potential to lead to adverse renal effects including acute renal failure which is more common when Zurampic is given alone as it should be used in combination with a xanthine oxidase inhibitor. Brilinta has a warning in its prescribing information regarding discontinuation of the medicine. Missed doses of Brilinta increases the risk of heart attack and stroke. People who are treated with a stent and miss doses of Brilinta have a higher risk of getting a blood clot in the stent, having a heart attack, or death. Patients should not stop taking Brilinta without talking to their prescribing doctor. To date, AstraZeneca has not received any reports of adverse events related to this recall. BACKGROUND: This is limited to one lot (Brilinta lot #JB5047) of professional sample bottles containing eight tablets of Brilinta 90 mg distributed to physicians in the US between March and April of 2017. Other forms and dosage strengths of Brilinta, including medicine obtained via US retail or mail order pharmacies, are not affected by this voluntary recall. This recall does not affect Zurampic. RECOMMENDATION: AstraZeneca is notifying physicians by recall letter and is arranging for return of all recalled products. Consumers that have medicine which is being recalled should contact their physician. Healthcare 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:
Please see the complete MedWatch Safety Alert at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm560786.htm You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com. This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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