Eliquis (generic name apixaban) is one of the newest anticoagulant drugs on the market. The U.S. Food and Drug Administration (FDA) approved Eliquis in 2012 to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation. Bristol-Myers Squibb developed Eliquis and markets the drug along with Pfizer.
Recently, the drug has been the subject of controversy as patients and experts scrutinize the process by which the drug attained FDA approval, and suggest that Bristol-Myers Squibb and Pfizer are downplaying safety concerns with Eliquis.
Eliquis is a factor Xa inhibitor medication. It blocks a natural substance in the body that assists in forming blood clots, thus preventing blood clotting.
The FDA has approved Eliquis for the following uses:
- To reduce the risk of blood clots (systemic embolisms) and strokes in patients with non-valvular atrial fibrillation (irregular heartbeat).
- To reduce the risk of deep vein thrombosis (DVT) following hip or knee replacement surgery.
- To treat patients with DVT or pulmonary embolisms and reduce recurrence.
Eliquis Controversies Draw Safety, Effectiveness into Question
Controversy surrounding Eliquis largely centers around the process it went through to get approval from the FDA. The ARISTOTLE clinical trial – short for Apixaban for Reduction in Stroke and Other Thrombotic Events in Atrial Fibrillation – was supposed to evaluate the drug for its efficacy in reducing stroke among patients with atrial fibrillation, and demonstrate that it is more effective than alternatives like warfarin.
Alleged Cover-Up and Claims of Mortality Reduction
But allegations of a cover-up, among other concerns, delayed approval of the drug.
The ARISTOTLE trials included trials in 40 different countries. In one of the trials in China, a clinic is said to have failed to report a few adverse events and was late in reporting a few others. It is also said to have left out medical outcomes for a few more patients. Further, some of the English language records did not match their Chinese counterparts.
The manufacturers also wanted to claim that the drug was more effective than warfarin at reducing all-cause mortality. But the statistical significance of such a claim was minuscule and the FDA rejected the request to include the claim on the drug’s label.
Controversy About Drug’s Approval
Of course, Eliquis eventually attained FDA approval following the publication of the ARISTOTLE trials in the New England Journal of Medicine (NEJM) in 2011. But even then, controversy followed the drug.
A former editor of the NEJM, Dr. Arnold Relman, pointed out conflicts of interest with the study, according to a guest post on Forbes. Some of the listed study authors were employees of Bristol-Myers Squibb.
He further notes the study failed to mention that Eliquis was no more effective than warfarin for 7,000 patients recruited in Europe, and more than a third of patients taking warfarin in the trials were not taking a therapeutic dose. He says this was a big problem because the group taking warfarin had higher rates of blood clotting and stroke compared to patients in the group taking Eliquis perhaps because some members of the warfarin group were not taking the correct dose.
Nevertheless, the FDA approved Eliquis in 2012. But because of all these controversies, some experts question whether the drug is as safe and effective as the manufacturers claim.
Eliquis & the Risk of Bleeding
Eliquis users have reported several mild to severe side effects. The most common side effect is uncontrollable bleeding. Patients who experience unusual bleeding or bruising or cannot control these symptoms should seek medical help.
The risk of bleeding increases for patients who are taking:
- Nonsteroidal anti-inflammatory drugs (NSAIDs)
- Warfarin (Coumadin)
- Selective serotonin reuptake inhibitors (SSRIs)
- Serotonin-norepinephrine reuptake inhibitors (SNRIs)
Some over-the-counter medications, vitamins, and herbal supplements can also increase the risk of bleeding.
Lack of Antidote
One of the major risks of Eliquis is that it does not have an antidote. Other anticoagulants have antidotes that doctors use to stop bleeding. For example, vitamin K is an antidote for uncontrolled bleeding related to warfarin.
In 2015, Portola Pharmaceuticals submitted an antidote for Eliquis for FDA approval. The FDA denied the request in August 2016, citing the need for more information regarding the antidote’s manufacturing process and stating that the agency needed to further review the company’s post-marketing commitments.
Other Side Effects of Eliquis
Patients should bring the following symptoms to a doctor’s attention immediately. If they become severe, patients should visit the emergency room as soon as possible.
- Bleeding gums
- Chest pain or tightness
- Coughing/vomiting blood
- Heavy vaginal bleeding
- Feeling dizzy or faint
- Red or black tarry stools
- Red, pink, or brown urine
- Swelling of face or tongue
- Swelling or joint pain
- Trouble breathing
- Unexpected pain, swelling, or joint pain
- Coughing/vomiting dark material that looks like coffee grounds
Lawsuits After Eliquis-related Injuries or Death
Experts expect that lawsuits against Bristol-Myers Squibb and Pfizer will grow as patients raise concerns about the drug and whether the manufacturers concealed information about its safety. One lawsuit, filed by a woman whose husband died from gastrointestinal and brain hemorrhage while he was taking the drug, alleges the manufacturers did not reveal concerns about the drug’s safety to her husband or his doctor.
Patients and the family of gravely or fatally injured patients should discuss their right to file a claim against the manufacturers of Eliquis with a lawyer. If you or a loved one experienced any of the following symptoms while using Eliquis, seek legal counsel:
- Pulmonary embolism
- Internal bleeding
- Systemic embolisms
- Recurrent deep vein thrombosis
For help finding a lawyer who can help with your case, call 1-800-DRUG-411 or complete the case evaluation form below.