FDA MedWatch - Brilinta (ticagrelor) 90 mg tablets, 8-count Physician Sample Bottles: Recall of Lot # JB5047 - Due to Report of Another Medicine in One Bottle

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Brilinta (ticagrelor) 90 mg tablets, 8-count Physician Sample Bottles: Recall of Lot # JB5047 - Due to Report of Another Medicine in One Bottle

AUDIENCE: 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.
Brilinta is indicated to reduce the rate of CV death, heart attack and stroke in patients with acute coronary syndrome (ACS) or a history of heart attack. Brilinta also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS. Zurampic is a prescription medicine used together with a xanthine oxidase inhibitor such as allopurinol or Uloric in adults with gout who still have a high uric acid level.
Brilinta 90 mg tablets are supplied as a round, biconvex, yellow, film-coated tablet, and imprinted with 90 above a T on one side of the pill. Zurampic tablets 200 mg are blue in color and elliptical/oval in shape. They are imprinted with LES200 on one side of the pill.

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:

• Complete and submit the report Online: www.fda.gov/MedWatch/report

• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Please see the complete MedWatch Safety Alert at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm560786.htm