Eliquis Complications & Lawsuits
Eliquis (generic name apixaban) is among the newest anticoagulant Drugs available on the market.
Eliquis was approved by The U.S. Food and Drug Administration in 2012 to decrease the chance of stroke and blood clots in patients using non-valvular atrial fibrillation. Bristol-Myers Squibb developed Eliquis and markets the medication together with Pfizer.
Lately, the medication caused a lot of controversy, with patients and experts questioning the process by which the medicine got the FDA approval. It’ has been suggested that Pfizer and Bristol-Myers Squibb are downplaying safety issues with Eliquis.
Eliquis is a factor Xa inhibitor medicine that prevents the natural substance within the body that helps in forming blood clots, therefore stops blood clotting.
The FDA has accepted Eliquis for the following applications:
- 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 mostly revolves around the process Eliquis went to get the approval from the FDA.
Alleged Cover-Up and Claims of Mortality Reduction
The ARISTOTLE trials contained trials in 40 unique nations. Among those trials, one clinic in China, allegedly has neglected to record a few misfortunate events and has been late in reporting several others. It’s also thought to have left medical outcomes for a couple more patients. Moreover, a number of those English Language documents didn’t fit their Chinese counterparts. The producers also asked to claim that the medication was more effective in reducing all-cause mortality than warfarin.
However, the statistical importance of such claim has been minuscule, and the FDA refused their request to include the disclaim on the drug’s label.
Controversy About Drug’s Approval
Evidently, following the publication in the New England Journal of Medicine of the ARISTOTLE trials in 2011, Eliquis finally attained FDA approval. Nevertheless, even then, controversy followed the medication.
Dr. Arnold Relman, a former editor of the NEJM, in a guest post on Forbes, pointed out conflicts of interest with the study, as some of the credited authors in the study were actually employees of Bristol-Myers Squibb.
Relman also noted the study failed to mention that Eliquis wasn’t more successful than warfarin for 7,000 patients experienced Europe, and over a third of patients taking warfarin from the trials weren’t carrying a therapeutic dose.
He states this was a big issues because the group of patients taking warfarin had greater degrees of blood clotting and stroke compared with individuals in the group carrying Eliquis possibly because some members of the warfarin group were not taking the appropriate dose. Despite all that, the FDA accepted Eliquis at 2012. Due to all the controversies, some experts are questioning the safety and efficiency of the drug.
Eliquis & the Risk of Bleeding
The most frequent complication is uncontrollable bleeding.
Patients experiencing irregular bruising or bleeding or can’t control these symptoms should seek Medical assistance.
There is an increased risk of bleeding 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 Drugs, vitamins, Minerals, and herbal Nutritional Supplements may also increase the chance of bleeding.
Lack of Antidote
Among the major dangers of Eliquis is that it doesn’t have an antidote. Additional anticoagulants have antidotes that physicians use to prevent bleeding. By way of instance, vitamin K is also an antidote for uncontrolled bleeding linked to warfarin.
In 2015, Portola Pharmaceuticals submitted an antidote for Eliquis to get FDA approval. The FDA denied the request in August 2016, mentioning the need for more details concerning the antidote’s manufacturing process and saying that the bureau required to additional review the organization’s post-marketing responsibilities.
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 anticipate that lawsuits against Bristol-Myers Squibb and Pfizer will rise as patients increase concerns about the medication and whether the manufacturers concealed information about its safety. One lawsuit, filed by a woman whose husband died from brain and gastrointestinal hemorrhage while he had been taking the medication, alleges the producers didn’t disclose concerns about the drug’s safety to her husband or his physician. Patients and the household of gravely or fatally injured patients should talk about their right to file a claim against the producers 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 (914) 200-0013