A new Eliquis lawsuit accuses the drug maker of failing to warn doctors and the public that the anticoagulant drug can cause uncontrollable gastrointestinal bleeding and other injuries for which there is no antidote.

Plaintiff Wright W. of Louisiana alleges that his use of the blood thinner caused him to suffer life threatening Eliquis internal bleeding events. Wright was prescribed Eliquis, also known as apixaban, due to a risk of blood clots and stroke.

He alleges that as a direct result of using Eliquis, he experienced serious injuries including hemoptysis and gastrointestinal bleeding, along with severe pain and suffering.

Questions Raised Over Eliquis Study Data

According to the Eliquis lawsuit, Bristol-Myers Squibb received FDA approval to market Eliquis in 2012 for use to reduce the risk of stroke caused by a blood clot in people with non-valvular atrial fibrillation.

The drug was later approved for use after hip or knee replacement surgery to prevent deep vein thrombosis, and to treat patients with deep vein thrombosis and pulmonary embolism.

Approval of the drug was based in large part on clinical trials known as the ARISTOTLE study. The ARISTOTLE study’s findings showed that apixaban was superior to warfarin for the prevention of stroke or systemic embolism in patients with atrial fibrillation, with a lesser risk of bleeding and lower mortality, the complaint says.

However, as per the Eliquis lawsuit, the drug maker failed to disclose that approval of apixaban to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation was delayed due to an FDA investigation regarding the quality of the data in the pivotal clinical trials.

“Such major trial errors call into question the validity of the data in the clinical trials supporting the other indications as well,” the lawsuit states.

FDA Reports Eliquis Internal Bleeding Events

The FDA has reported that as of 2014, there were 1,014 Eliquis-associated “Serious Adverse Event Medwatch reports filed with the Agency, including 492 hemorrhagic events and at least 108 deaths.”

The maker of Eliquis, however, allegedly failed to alert the public and the scientific community of this data and did not further investigate the safety of Eliquis, according to the Eliquis lawsuit.

Eliquis Lawsuit Information

Many patients who have filed Eliquis lawsuits claims that Bristol-Myers Squibb overstated the efficacy of Eliquis with respect to preventing stroke and systemic embolism.

They also claim the drug company failed to adequately disclose to patients that there is no means to reverse the anticoagulation effects of Eliquis, putting patients at risk for life-threatening and fatal consequences.

If you or someone you love suffered from Eliquis side effects including gastrointestinal bleeding or other irreversible internal bleeding event, you may have grounds to file an Eliquis lawsuit against Bristol-Myers Squibb.

While an Eliquis lawsuit cannot take away the pain and suffering endured, it can help to compensate for medical expenses and lost income or wages and hold the drug maker responsible for releasing a dangerous drug into the market.

The Eliquis Lawsuit is Case No. 3:16-273 in the U.S. District Court for the Middle District of Louisiana.