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The blood-thinning drug Brilinta has been linked to serious adverse events, including severe bleeding, heart attack, stroke, and death. A federal lawsuit alleges that clinical trial data was manipulated to downplay these risks.

Brilinta Lawsuit Accuses AstraZeneca of Manipulating Study

Brilinta is a blood-thinning drug that was approved by the FDA in July 2011 for patients with acute coronary syndrome or a history of heart attacks. The manufacturer, AstraZeneca, gained approval based on the PLATO trial, an 18,000-patient study that found Brilinta patients had a lower risk of heart attacks, stroke, and death than patients on Plavix.

In February 2014, the Wall Street Journal reported that a federal lawsuit had been filed against AstraZeneca by Dr. Victor Serebruany, a medical professor at Johns Hopkins Hospital who said study data may have been manipulated.

In an FDA Medical Review, investigators found that 46% of the patients who had good outcomes on Brilinta came from just two countries — Poland and Hungary — which had more than double the number of patients from the United States and Canada combined.

In the part of the study based in the United States, results were opposite — patients on Brilinta had a 27% increased risk of heart attack, stroke, and vascular death.

However, the FDA blamed the increase on high-dose aspirin used by some patients on Brilinta, which may have interfered with how it worked. The label on Brilinta now carries a “Boxed Warning” that aspirin doses above 100-mg reduce the effectiveness of Brillinta and should be avoided.

Dr. Serebruany also alleged that serious adverse events were not reported to the FDA, which may have skewed data was in favor of Brilinta. For example:

“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 (this was not shown in the FDA review).”

In response to the lawsuit, the U.S. Department of Justice opened an investigation in October 2013. Just nine months later, the inquiry closed and AstraZeneca did not add warnings to the label.