Brilinta, a new blood thinning medication marketed by AstraZeneca, may not be as safe as the drug maker claims. In 2013, a review published in the International Journal of Cardiology suggested that there were numerous instances where AstraZeneca fudged data in a key clinical trial to inflate the benefits of Brilinta. Among other things, the authors of the review asserted that the number of Brilinta heart attacks that occurred during the study had been underreported.
The nationwide law firm of Bernstein Liebhard LLP is now offering free legal reviews to individuals who allegedly suffered heart attacks or other complications while using Brilinta. To learn more, please call our office at (888) 994-5118.
Brilinta’s 2011 approval by the U.S. Food & Drug Administration (FDA) was largely based on the PLATO study, a clinical trial that involved 18,000 patients from around the world who were treated with either Brilinta or Plavix. The study reported that, overall, Brilinta-plus-aspirin was found to be more effective than Plavix-plus-aspirin at preventing heart attack, stroke, and death.
In 2013, FDA reviewers writing in the International Journal of Cardiology raised serious concerns about the reliability of PLATO. According to the reviewers, irregularities in data presented in the PLATO trial made Brilinta appear to be safer and more effective than it actually is. “An estimated 23 definite or possible cardiovascular events or deaths on ticagrelor (Brilinta) were either not submitted for adjudication, inactivated, deleted or were downgraded to ‘softer’ endpoints,” they wrote.
While PLATO was a worldwide trial, the FDA reviewers found that only the results from Poland and Hungary showed a statistically significant advantage for Brilinta. These two countries accounted for 21% of the enrolled patients but 46% of the excess strokes, heart attacks and vascular deaths experienced by the subjects treated with Plavix. In the U.S. portion of the study, Brilinta actually did worse than Plavix and was linked to a 27% greater incidence of vascular deaths, heart attacks and stroke. Overall, the review indicated that Brilinta heart attacks were underreported, and suggested that problems with Plavix had been reported more harshly and more frequently compared to those associated with Brilinta.
The PLATO trial was also designed to be blinded, meaning that neither doctors nor patients should have known they which drug they were taking. But the authors of the review found that “PLATO was easy to unblind by breaking open a clopidogrel/dummy clopidogrel tablet with at least 452 patients being unblinded prior to the database lock.”
The U.S. Department of Justice opened an investigation into the PLATO trial shortly after the review appeared in the International Journal of Cardiology. However, the probe ended one year later, with prosecutors taking no action.
If you or a loved one experienced a heart attack while using Brilinta, now is the time to seek legal advice. To arrange for your free, no-obligation case review, please contact Bernstein Liebhard LLP at (888) 994-5118.
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