The results of AstraZeneca’s recent trials for its blood-thinning drug Brilinta show a decreased risk of post–heart attack heart problems but an increased risk of major bleeding after using the drug. The pharmaceutical company’s large-scale PEGASUS-TIMI 54 trial included 21,000 patients who had suffered at least one heart attack in the past three years. Patients received either a high dose of Brilinta, a low dose of Brilinta, or a placebo drug. All patients additionally received aspirin for the duration of the trial.
The study, which was published in The New England Journal of Medicine, found that taking Brilinta with aspirin reduced the risk of dying from heart problems, a repeat heart attack, or a stroke by 15 to 16 percent. However, patients who received Brilinta were two times more likely to experience major bleeding than those in the placebo group. The rate of major bleeding was found to be 2.6 percent in patients who received a high dose of Brilinta, 2.3 percent in those who received a low dose, and 1.1 percent in patients who received a placebo. More Brilinta patients exited the study due to side effects like shortness of breath.
Health experts have expressed the concern that Brilinta is approaching a point of “diminishing returns,” where adverse events like major bleeding outweigh the intended blood-thinning benefits of the drug. As The New England Journal of Medicine projects, “on the basis of the 60-mg ticagrelor dose, treating 10,000 patients for 1 year would prevent approximately 42 primary end-point events and produce approximately 31 TIMI major bleeding events—close to an even proposition.”
The problems AstraZeneca faces with Brilinta are similar to those Bayer and Janssen Pharmaceuticals face with Xarelto. Xarelto was approved by the FDA in 2011 as a blood-thinning drug intended to prevent blood clotting in patients undergoing certain surgeries and patients with irregular heartbeats. Unfortunately, according to plaintiffs in Xarelto lawsuits, the drug can cause patients to bleed to death.
Earlier this year, over 100 Xarelto lawsuits were consolidated in a multidistrict litigation.
The blood-thinning drug Pradaxa also received attention after reports of major bleeding began mounting. Over 4,000 Pradaxa lawsuits were filed, including 500 cases of death, resulting in $650 million in settlements from Pradaxa manufacturer Boehringer Ingelheim Pharmaceuticals.
Consult your doctor or physician whenever you wish to change medications. If you or someone close to you has suffered major bleeding after taking a blood-thinning drug like Xarelto or Pradaxa, contact the lawyers at Lopez McHugh. You may be entitled to damages through a product liability lawsuit.