Brilinta Recall Issued Due to Risk Samples May Contain Zurampic

Federal health officials have recalled a certain lot of the blood thinner Brilinta, after discovering that sample packages distributed to doctors may contain Zurampic, a drug used to treat high levels of uric acid in the blood, which may pose a variety of serious and potentially fatal risks to patients.

The U.S. Food and Drug Administration (FDA) announced the Brilinta recall on May 26, indicating that at least one professional sample bottle with eight tablets of Brilinta 90mg also contained Zurampic 200mg tablets, which may cause patients requiring blood thinners to miss doses and put them at risk of bleeding events. In addition, side effects of Zurampic may also increase the risk of acute renal failure due to the unintentional use of the medication.

Brilinta is a blood thinner used to reduce the risk of CV death, heart attacks and strokes in patients with acute coronary syndrome (ACS), or by those with history of heart attacks. Brilinta is also commonly used to reduce the rate of stent thrombosis in patients who have received stents for treatment of ACS.

Failure to receive the prescribed dosage of Brilinta may result in serious and potentially fatal outcomes. According to the manufacturer, AstraZeneca, missed doses of Brilinta increase the risk of heart attacks and strokes, and those taking Brilinta for treatment of an implanted stent run an increased risk of getting a blood clot or having a serious heart attack.

Zurampic, a drug also manufactured by AstraZeneca, is a prescription medication used in combination with a xanthine oxidase inhibitor in adults with gout to treat high levels of uric acid.

Clinical trials and past warnings by the medical community have found evidence that using Zurampic without the combined use of a xanthine oxidase inhibitor may lead to adverse renal effects including acute renal failure.

The FDA is urging medical professionals and patients that have received professional sample bottles of Brilinta 90mg tablets containing eight pills with bottles marked with the recalled Lot Number JB5047, to contact their healthcare provider immediately.

Although the unintentional dosing of Zurampic with Brilinta may have serious side effects, the FDA is asking patients to not stop taking their prescriptions until they have contacted their healthcare providers, as the intentional stopping of Brilinta is nearly certain to result in serious adverse health consequences, and even death.

Customers and healthcare professionals should be aware that Brilinta 90mg tablets are supplied as a round, biconvex, yellow, film-coated tablet imprinted with “90” above a “T” on one side of the pill, whereas Zurampic 200mg tablets are blue in color and elliptical/oval in shape and are imprinted with “LES200 on one side of the pill.

The recalled Brilinta sample bottles were manufactured by AstraZeneca of Wilmington, Delaware where they were distributed to physicians in the United States between March 2017 and April 2017.

According to the FDA, no other lots of AstraZeneca’s Brilinta are impacted by the recall. AstraZeneca has begun reaching out to customers across the nation with a recall letter and arrangements to return all of the recalled products. Patients with the recalled prescriptions are being asked to continue taking the medication as normal but to contact their healthcare provider immediately.

Patients and physicians with additional questions or concerns regarding the recall may contact AstraZeneca Information Center at 1-800-236-9933. The FDA is asking for all adverse health events to be reported to the FDA’s MedWatch Adverse Event Reporting program immediately by completing and submitting the report online at www.fda.gov/medwatch/report.htm or by calling 1-800-332-1088.

Brilinta, also known as ticagrelor, was developed by AstraZeneca and approved by the FDA in July 2011, carrying a black box warning for bleeding risks, similar to that of other blood thinners.

However, in September 2016, a study by European researchers published in the medical journal JAMA Cardiology, examined the side effects of Brilinta among patients with acute coronary syndromes, comparing use of the blood thinner with or without aspirin before undergoing coronary artery bypass grafting. The findings suggest that taking Brilinta up to, or at least two days before, such surgeries increases the risk of severe bleeding events by nearly 20%. After reviewing nearly 800 Brilinta users across 15 cardiac surgery facilities in Europe, researchers found that preoperative use of Brilinta up to the time of surgery or discontinuing it less than two days before surgery was associated with a 22.7% higher risk of platelet transfusion and an 18.2% increased risk of severe bleeding events when compared to patients given aspirin alone.