What is Brilinta?
Brilinta (generic: ticagrelor) is an “anti-platelet” medication that helps prevent stroke or serious heart problems in patients who have had a heart attack or severe chest pain (angina). The drug works by preventing platelets in the blood from sticking together and forming a blood clot. Brilinta is made by AstraZeneca, and was approved by the U.S. Food & Drug Administration (FDA) in July 2011.
What’s the Problem?
Our lawyers are reviewing potential lawsuits on behalf of patients who suffered serious side effects or death after taking Brilinta. Reports have surfaced indicating that AstraZeneca manipulated clinical data to get Brilinta approved by the FDA. Falsification of this data means that patients may have been prescribed Brilinta without their doctors fully understanding the risks associated with use of the drug. Additionally, failure to submit complete clinical trial data to the FDA means that Brilinta’s side effects may occur more often than previously believed, exposing patients to substantial and uninformed risks.
Brilinta vs. Plavix
Brilinta was designed as an alternative to the antiplatelet medication Plavix (generic: clopidogrel). From 2006 to 2008, AstraZeneca sponsored the Platelet Inhibition and Patient Outcomes (PLATO) clinical trial to compare the safety and efficacy of the two drugs. In 2009, the company reported that results of the trial found that patients treated with Brilinta had significantly improved outcomes compared to patients who took Plavix. As a result of the PLATO trial, FDA approved Brilinta, with AstraZeneca marketing the drug as being superior to Plavix.
AstraZeneca Accused of Manipulating PLATO Trial Data
A number of irregularities were exposed following the conclusion of PLATO which raised concerns that AstraZeneca had altered data to make Brilinta appear safer than it actually is. Specifically, the company was accused of omitting and/or falsifying adverse event data regarding patient deaths and heart attack rates from submissions made to the FDA.
“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,” said James DiNicolantonio, Pharm.D., and Dr. Ales Tomek, authors of a report in the International Journal of Cardiology that raised concerns about the reliability of the PLATO trial.
Brilinta Side Effects
- Heart attack
- Internal bleeding
- Rectal bleeding
- Cerebral hemorrhage
- Digestive tract ulcers
- Kidney failure
- Pulmonary embolism (PE)
- Deep vein thrombosis (DVT)
- And More
“Black Box” Warning
The labeling of Brilinta carries a boxed warning which states that aspirin doses above 100 milligrams per day may decrease effectiveness of the medication. Brilinta may also increase the rate of bleeding and cause significant, potentially fatal bleeding events. The most common adverse reactions associated with Brilinta in clinical trials were bleeding and difficulty breathing (dyspnea), according to the FDA.
Are Lawsuits Being Filed?
AstraZeneca is currently facing numerous lawsuits alleging that it altered Brilinta clinical trial data, exposing patients to a risk of severe, potentially life-threatening side effects unknown not only to them but their prescribing doctors and the healthcare community as well. As a result of the manipulated data, patients suffered unnecessary injuries after taking Brilinta, including gastrointestinal bleeding, ulcers, heart attacks, strokes and blood disorders.
2006-2008 – PLATO clinical trial sponsored
2006-2008 – AstraZeneca sponsors the PLATO clinical trial which compares Brilinta to Plavix.
2009 – PLATO finds improved outcomes
2009 – AstraZeneca announces that PLATO finds improved outcomes in patients treated with Brilinta compared to those who took Plavix.
February 2011 – FDA assigns new act
February 4, 2011 – FDA assigns new Prescription Drug User Fee Act (PDUFA) date for Brilinta.
July 2011 – Approved by the FDA
July 20, 2011 – Brilinta approved by the FDA to treat acute coronary syndromes.
October 2013 – International Journal of Cardiology study published
October 9, 2013 – Study published in the International Journal of Cardiology questions results of the PLATO trial, finding that “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.”
March 2015 – New option approved
March 30, 2015 – New “crushing option” approved for the administration of Brilinta.
- “FDA approves blood-thinning drug Brilinta to treat acute coronary syndromes”. U.S. Food & Drug Administration (FDA). July 20, 2011.
- “Angiographic outcomes in the PLATO Trial (Platelet Inhibition and Patient Outcomes)”. JACC: Cardiovascular Interventions. July 2013.
- “Inactivations, deletions, non-adjudications, and downgrades of clinical endpoints on ticagrelor: Serious concerns over the reliability of the PLATO trial”. International Journal of Cardiology. October 9, 2013.
- “Brilinta (ticagrelor) 90 mg Tablets. Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)”. U.S. Food & Drug Administration (FDA). July 2016.