FDA reviewers have found evidence of skewed clinical trial data on Brilinta, raising concern about life-threatening side effects like bleeding, heart attack, and stroke. Although bleeding is the most common side effect, Brilinta lacks a reversal agent and patients can potentially bleed uncontrollably.
Brilinta (ticagrelor) is an anti-clotting (blood-thinning) drug that is used to prevent blood clots from clogging arteries in the heart. It helps prevent recurrent heart attack, stroke, and death in patients who have severe chest pain (unstable angina) or a recent heart attack.
Like all blood-thinners, Brilinta carries a “Boxed Warning” about bleeding that can be severe and fatal. The most severe side effects of Brilinta include:
- Heart attack
- Cardiovascular events
PLATO Clinical Trial
In 2009, AstraZeneca presented data from the PLATO clinical trial, which involved 18,000 patients and compared Brilinta to its main competitor, Plavix (clopidogrel). Overall, the study concluded that Brilinta-plus-aspirin was more effective than Plavix-plus-aspirin at preventing heart attack, stroke, and death. Based on these results, the FDA approved Brilinta in July 2011.
Did AstraZeneca Manipulate Clinical Trial Data?
In August 2013, medical reviewers for the FDA published a long list of irregularities in the PLATO study, suggesting that AstraZeneca may have skewed the results so Brilinta seemed better than Plavix.
One example of suspicious data:
“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).”
- Brilinta was shown to be more beneficial for patients who were monitored by AstraZeneca, compared to patients who were monitored by an independent organization.
- Patients from Poland and Hungary made up 21% of the subjects — more than double the number from the United States and Canada combined
- 46% of patients who had a favorable outcome on Brilinta came from Poland and Hungary
- Heart attacks and hospitalizations linked to Brilinta were under-reported compared to similar events linked to Plavix.
- Patients could tell whether they were getting Plavix by breaking open the tablet.
Justice Department Investigates PLATO Study
The U.S. Department of Justice (DOJ) opened an investigation into possible data-manipulation in October 2013. Less than a year later, prosecutors closed their investigation and took no action. No further investigations are planned.
Lack of Reversal Agent for Bleeding
In November 2014, Reuters reported that AstraZeneca started developing a reversal agent for Brilinta to counteract its blood-thinning effects. Major bleeding is the most common serious side effect of Brilinta, but stopping bleeding in an emergency can be very difficult or impossible without a reversal agent.
Brilinta Class Action
The Wall Street Journal reports that a federal lawsuit was filed against AstraZeneca by Dr. Victor Serebruany, a medical professor at Johns Hopkins Hospital who warned that data from the PLATO study may have been manipulated. Lawsuits involving Brilinta have already been filed, but our attorneys are not filing a Brilinta class action. Instead, we are filing individual lawsuits for people with severe injuries like heart attack, stroke, or bleeding.