AstraZeneca introduced Brilinta as a superior alternative to the blood thinner Plavix, and the drug maker has since been accused of falsifying clinical trial data and misrepresenting the safety of Brilinta while downplaying its risks, which means that patients may have been prescribed the anticoagulant drug without their doctors fully understanding the risks associated with Brilinta treatment. If you believe you have been adversely affected by uncontrollable bleeding or another alleged Brilinta side effect, contact a knowledgeable product liability lawyer today to discuss your legal options. You may have grounds to file a Brilinta lawsuit against AstraZeneca, in order to pursue financial compensation for your injuries, medical expenses, pain and suffering, and other related damages.
Because Brilinta has been linked to an increased risk of uncontrollable bleeding and other serious and potentially life-threatening complications, many patients at risk for heart attacks and strokes are seeking safer alternatives to the anticoagulant medication. Some possible natural alternatives to anticoagulant therapy for reducing the risk of blood clots, stroke and other serious cardiovascular problems include:
Brilinta (ticagrelor) is an anticoagulant medication manufactured by AstraZeneca and prescribed to prevent blood clots and recurrent heart attacks and strokes in patients who have suffered a recent heart attack or severe chest pain (unstable angina). Brilinta was approved by the U.S. Food and Drug Administration (FDA) in July 2011, and, rather than “thinning” the blood, the drug works by actually preventing red blood cells (platelets) from sticking to one another. This reduces the likelihood of blood clots forming or growing larger, but at the same time, increases a person’s risk of experiencing bleeding complications. Because Brilinta does not have an approved antidote, or reversal agent, patients taking the anticoagulant drug can bleed uncontrollably, especially if they end up needing emergency surgery.
Like all blood thinners, Brilinta carries a black box warning highlighting the potential for the anticoagulant drug to cause uncontrollable internal bleeding that can be severe and possibly even fatal in some instances. The most serious side effects allegedly associated with Brilinta treatment include:
The FDA approved Brilinta based on data from the Platelet Inhibition and Patient Outcomes (PLATO) clinical trial, which involved 18,000 patients in 43 countries and compared the blood thinner to its main competitor, Plavix. The trial results indicated that taking Brilinta with aspirin was more effective than taking Plavix with aspirin to prevent heart attack, stroke and death. Two years after Brilinta entered the market though, medical reviewers for the FDA published a long list of irregularities found in the PLATO clinical trial, and reported that AstraZeneca may have intentionally manipulated the study results so that Brilinta appeared to be a better alternative to Plavix. According to the medical reviewers, “An estimated 23 definite or possible cardiovascular events or deaths on [Brilinta] were either not submitted for adjudication, inactivated, deleted or were downgraded to “softer” endpoints, and four FDA reviewers voted for non-approval of [Brilinta].”
Based on this information, the Justice Department in October 2013 launched an investigation into possible data manipulation, but soon after closed its investigation, taking no action against AstraZeneca or Brilinta. In February 2014, a medical professor at Johns Hopkins Hospital accused AstraZeneca of rigging its self-sponsored PLATO study to receive favorable results, reporting to federal investigators that the number of deaths in the clinical trial’s control group of patients taking Plavix was unusually high compared to earlier trials. He also questioned the number of heart attacks reported in the study, alleging that the numbers were deliberately skewed in favor of Brilinta. According to the study results, 9.8% of patients taking Brilinta suffered a heart attack, stroke or death over a period of 12 months, compared to 11.7% of patients taking Plavix.
February 2014 – A medical professor at Johns Hopkins files a lawsuit against AstraZeneca in the U.S. District of Columbia, alleging that the drug maker manipulated the results of the PLATO study.
August 2013 – Medical reviewers for the FDA publish a list of irregularities found in the PLATO clinical trial for Brilinta, including AstraZeneca’s failure to report serious adverse events in Brilinta users.
October 2013 – The U.S. Department of Justice opens an investigation into AstraZeneca’s conduct regarding clinical trials for its Brilinta blood thinner, amid accusations that the drug maker concealed evidence of possible heart problems linked to the medication.
November 2013 – The European Medicines Agency announces that it had contacted AstraZeneca for more information about the Justice Department’s investigation into problems with Brilinta.
August 2014 – The DOJ closes its investigation into the PLATO clinical trial for the blood thinner Brilinta, taking no legal action against AstraZeneca.
September 2009 – The results of the PLATO clinical trial are published in the New England Journal of Medicine, reporting statistically significant improved outcomes among patients taking Brilinta, compared to patients taking Plavix.
October 2013 – The International Journal of Cardiology publishes a report indicating that Brilinta clinical trial data presented to the FDA was manipulated prior to submission to improve the chances of marketing approval, and to make Brilinta appear safer than it is.
October 2013 – Research presented at the European Society of Cardiology indicates that many patients are unable to tolerate Brilinta treatment, and often discontinue use of the anticoagulant drug due to medical complications.
February 2014 – The Wall Street Journal publishes an article indicating that a federal lawsuit was brought against AstraZeneca by Dr. Victor Serebruany, a medical professor at Johns Hopkins Hospital who warned that the findings of the PLATO clinical trial may have been manipulated.
November 2014 – A report published in Reuters indicates that AstraZeneca has begun developing a reversal agent for Brilinta to counteract its blood-thinning effects.
March 2015 – While Brilinta can reduce the risk of a second heart attack in some patients, side effects of the anticoagulant drug may also increase the risk of dangerous bleeding events, according to a study published in the New England Journal of Medicine.
November 2015 – Approximately one in five patients taking Brilinta during trials discontinued use of the anticoagulant due to side effects, according to research presented during the Late Breaking Clinical Trial session at the 2015 American Heart Associated Scientific Sessions.
March 2016 – Results of AstraZeneca’s key SOCRATES clinical trial published by Reuters indicates that Brilinta isn’t any better than aspirin in helping patients with acute ischemic stroke or transient ischemic stroke, despite the company’s hopes of opening up a new market for the blood thinner.
Whether or not AstraZeneca actually manipulated the PLATO study results to make Brilinta look like the better choice for patients at risk for strokes and heart attacks, there’s no doubt that Brilinta is associated with a greater risk of serious complications than it was originally believed to be. In fact, in the U.S. portion of the clinical trial, Brilinta actually performed worse than Plavix, and was associated with a 27% higher risk of heart attacks, stroke and vascular deaths. Brilinta lawsuits brought against AstraZeneca in the future will likely allege that the drug maker:
Because Brilinta has no approved antidote, bleeding problems from the medication may be uncontrollable and can lead to hypovolemic shock, a serious complication occurring in patients who lose at least 20% of their blood. Life-threatening complications of uncontrollable bleeding and hypovolemic shock may include brain damage, kidney failure, organ damage, gangrene, heart attack or death. If you took Brilinta in the past, and you have since suffered uncontrollable bleeding, heart attack, stroke, or another serious side effect, consult an experienced Brilinta attorney to explore your possible compensation options. With a knowledgeable product liability lawyer on your side, you can protect your legal rights and seek fair and timely reimbursement for your losses.