Eliquis, which was jointly created and developed by drug companies Pfizer and Bristol-Myers Squibb, is a blood thinner used to treat deep vein thrombosis and other conditions. As a blood thinner, there are serious risks of taking this medication, although the companies that made and tested it claim it is safer than other similar medications.
Accusations have been made against Pfizer and Bristol-Myers Squibb that they made serious mistakes in clinical trials for Eliquis and that they tried to cover up those mistakes. The results and the claims they make about the drug’s safety and effectiveness may be skewed as a result. If you have taken Eliquis and have suffered serious consequences such as excessive bleeding or hemorrhaging, you may have a case against the drug makers.
Uses for Eliquis
Eliquis is the brand name for the drug called apixaban and it belongs to a class of drugs called anticoagulants. These are blood thinners that stop the coagulation process, the process by which blood forms clots. It was first approved by the U.S. Food and Drug Administration, the FDA, in 2014. It was approved in Europe in 2012 and other similar anticoagulants like Pradaxa and Xarelto were already in use in the U.S. These newer anticoagulants were created to be an alternative to the older blood thinner, warfarin, which has serious safety risks and the use of which must be carefully monitored.
The FDA approved Eliquis to prevent and treat embolisms. Embolisms are blood clots that may form anywhere in the body and which can be life-threatening if they move into the lungs, heart, or brain. More specifically, Eliquis is approved to reduce the risk of clot formation in people with valvular atrial fibrillation, to reduce the risk of deep vein thrombosis, clots in the legs, in people after having knee or hip surgery, and to treat existing blood clots and to prevent their reformation. In all of these uses, Eilquis ultimately acts to reduce the risk of death by stroke or pulmonary embolism.
How Eliquis Works
Eliquis and other anticoagulants are often called blood thinners for their ability to prevent blood from clotting. The name is misleading, though, as they don’t actually change the consistency or thickness of blood. They act in specific ways to prevent, or inhibit, part of the process of coagulation. For many years, warfarin was the only option for a blood thinner, but now there are several new drugs, including Eliquis.
Eliquis has a much more specific action than warfarin. It selectively inhibits a compound called Factor Xa. This compound is a part of the clot-formation process in blood and it helps to convert one enzyme to another in the final step in making a blood clot.
The Risk of Bleeding
Because anticoagulants prevent clot formation, they have the side effect of potentially causing excessive bleeding. This can be very dangerous and possibly life-threatening. According to the manufacturers, Eliquis carries a lower risk of bleeding when compared to warfarin because its effectiveness wears off more quickly. On the other hand, warfarin has an antidote, or a medication that can be taken to reverse its anticoagulant effect in the case of an emergency.
Eliquis does not have any kind of antidote. If you start bleeding excessively while taking it, there is no mediation available to reverse it. This can be a big problem in the event of an accidental injury or if emergency surgery is needed. The risk of dangerous bleeding on Eliquis is worsened if you take certain other medications like aspirin, heparin, non-steroidal anti-inflammatory drugs, and the antidepressants serotonin norepinephrine reuptake inhibitors.
Other Side Effects
The risk of out-of-control bleeding is one of the most dangerous possible side effects of Eliquis and other blood thinners. Signs that you may be bleeding in a way that is not normal include nosebleeds, discolored urine, vaginal bleeding, bleeding gums, coughing or vomiting blood, and red or tarry stools.
Other side effects that may occur with Eliquis include dizziness, fainting, chest pains, headache, rash, swelling in the face and mouth, wheezing, and difficulty breathing. If you experience any of these symptoms or the signs of bleeding, you should contact your doctor right away or seek emergency medical attention if you can’t reach your doctor.
Black Box Warnings
After evaluating the risks of using Eliquis, the FDA required that the medication inserts carry a black box warning. This type of warning is reserved for the most serious and life-threatening risks that come with taking a drug. There are two such warnings on Eliquis. The first warns against prematurely stopping the use of Eliquis, as this increases the risk of the formation of a blood clot, which can be deadly. You should only ever stop taking this medication under the direction of your doctor.
The second black box warning is the risk of paralysis in patients who have an epidural, spinal anesthesia, or other type of spinal puncture while taking Eliquis. Patients are warned to inform their doctors if they have had several spinal punctures, epidurals, spinal surgeries, or spinal injuries or deformities. Taking Eliquis with these issues can lead to the formation of a hematoma, which may cause long-term or even permanent paralysis.
Eliquis Trial Errors and Cover ups
Eliquis would have been approved by the FDA earlier than in 2012 if it hadn’t been for serious concerns over the clinical trials. The trial conducted by Bristol-Myers Squibb and Pfizer was supposed to prove that Eliquis was more effective and safer than any other blood thinner, but instead it raised some important issues and questions for the FDA.
The trial was called ARISTOTLE, and in reviewing it the FDA found evidence for fraud and mistakes in the dispensing of medication to trial patients. Misconduct during the trial in China initially delayed approval of the medication by three months. At least one trial location had evidence that someone had tried to cover up violations of good trial practice and evidence that there were serious adverse events in some patients. This led the FDA to investigate 24 other trial sites in China.
The cover up, ultimately, did not alter the results of the trials, but did delay approval. The second major hurdle and the second cause for delay was when the FDA found that the drug companies could not prove that the patients in the trial got the medication they were supposed to get. This could have a major effect on the results of the study and the determination of the drug’s effectiveness and safety.
Finally, the problem was taken care of, and eventually, after a nine-month delay, Eliquis got approval. However, it did not get the full approval the drug companies had hoped for. They had hoped that ARISTOTLE could prove that Eliquis reduced the risk of mortality in patients better than any other blood thinner. The FDA did not agree that their evidence was enough to back up that claim and would not allow a statement to that effect to be included in the drug information.
The results of ARISTOTLE were published in the New England Journal of Medicine, but critics say it should have been more critically reviewed. In spite of the FDA refusing to allow the information for Eliquis to state that it is better than other blood thinners, the published study included the claim that it is superior to warfarin, a claim that is dubious at best.
The first lawsuit filed against Eliquis’s makers involves the death of a man in New York. The plaintiffs argue that Bristol-Myers Squibb did not include an adequate warning on Eliquis packaging that there was no antidote to reverse excessive bleeding. They also state that the claim that the drug can be dosed the same for all patients is dangerous and contributed to the death.
If you have been harmed by taking Eliquis, you could be the next plaintiff in an important lawsuit. The companies making and testing this drug have been proven to have already made many mistakes in bringing it to market. If there are safety concerns that have not been emphasized enough, patients are the ones to suffer.
- http://www.forbes.com/sites/larryhusten/2013/06/21/roller-coaster-path-to-approval-for-eliquis-uncovered-by-fda-documents/ - 56f3b7446558