Brilinta Side Effects May Increase Bleeding Risks During Heart Surgery: Study

Individuals who receive the blood thinner Brilinta before certain types of heart surgery may face an increased risk of severe bleeding, according to the findings of new research. 

In a study published last week in the medical journal JAMA Cardiology, European researchers 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%.

Brilinta (ticagrelor) is a type of blood thinner known as a platelet aggregation inhibitor. It was developed by AstraZeneca and approved by the FDA in July 2011. It carries a black box warning for bleeding risks, similar to that of other blood thinners.

The clinical trial was conducted at 15 European facilities for cardiac surgery and involved nearly 800 patients. The researchers said the findings could be important in determining when or if to take patients off Brilinta treatment before cardiac surgery.

According to the findings, 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.

The findings are similar to those of a study published in the New England Journal of Medicine in March 2015, which found that Brilinta would cause 31 major bleeding events in every 10,000 previous heart attack victims who took the drug.

The findings also come amid questions about previous AstraZeneca-funded clinical trials, which were used to help secure FDA approval of the drug.

The U.S. Department of Justice launched an investigation into previous clinical trials on Brilinta in 2013, after a report identified a number of irregularities in a clinical trial and suggested that reports of heart attacks linked to Brilinta may have been under-reported.

In August 2013, a study published in the International Journal of Cardiology suggested that AstraZeneca may have manipulated data during an 18,000-patient clinical trial to make the drug appear safe when data suggested otherwise.

Among the irregularities was the fact that an independent review of the data found that 46% of all primary endpoint events favoring Brilinta came from just two countries, Poland and Hungary, despite the participation of subjects from numerous other countries. The review also found that heart attacks linked to Brilinta were under-reported in the clinical trial findings.

The trial, known as PLATO, was used to get Brilinta approved for the market in 2011. The company had hoped to make the drug one of its flagship medications, but to date sales have been disappointing.

In October 2013, a study was presented at the European Society of Cardiology, where researchers from the Netherlands warned that a significant number of patients are dropping the drug due to side effects of Brilinta, which include breathlessness and other health problems.