Eliquis is the brand name for the drug apixaban, an oral anticoagulant manufactured and sold jointly by American pharmaceutical companies Pfizer and Bristol-Myers Squibb.
Eliquis is part of a new class of blood thinning drugs that includes Xarelto and Pradaxa. These medications are designed to prevent blood clots without the dietary restrictions and regular blood tests required of the traditional drug warfarin.
Like Xarelto, Eliquis is a direct Factor Xa inhibitor. However, it is taken twice per-day instead of once per-day like Xarelto. Eliquis currently ranks near the top-25 most prescribed drugs in the United States, with more than 5 million prescriptions each year.
While initial clinical trial data for Eliquis indicated it may be the safest of the new blood thinners, officials have now questioned the reliability of these studies due to missing information.
Also, unlike with warfarin, there is no commercially available antidote to stop internal bleeding from Eliquis in cases of emergency. As a result, the FDA has received more than 750 reports of patients suffering internal bleeding injury or death.
This year, the first lawsuits were filed against the makers of Eliquis over internal bleeding.
Eliquis is prescribed to prevent stroke in patients with atrial fibrillation not caused by a heart valve. It is also used to fight deep vein thrombosis and pulmonary embolism, as well as blood clots in patients that have recently undergone knee or hip replacement surgery.
It works by inhibiting the enzyme Factor Xa, which is essential in the body’s natural formation of blood clots. Eliquis is not recommended for those with the heart disease mitral stenosis, or with artificial heart valves.
So far, Eliquis has been used by over 6 million patients and generated sales of more than $1 billion. It recently passed Pradaxa for the second-most prescribed anticoagulant on the market, but is still behind Xarelto.
Taken orally, approximately 50% of Eliquis is absorbed into the bloodstream from the digestive tract within 3-4 hours, while about 25% of the drug is excreted. It maintains its effectiveness for up to 6 hours with trace effects lasting as long as 12 hours. Therefore, it is most often prescribed as a twice-daily medication.
Xarelto is available in doses of 2.5 and 5 mg tablets, which is the lowest dosage of the three brand name anticoagulants.
Bristol-Myers Squibb and Pfizer submitted a New Drug Application to the FDA for approval of Eliquis after conclusion of the ARISTOTLE clinical trial in 2011.
The FDA initially gave Eliquis priority review status and set a decision date of March 28, 2012. However, they then delayed the decision by three months to June 28, 2012 while requesting additional information.
In a surprise move, the FDA then delayed its approval decision on Eliquis another six months, while it requested more information on the accuracy of the clinical data and how that data was stored.
Eliquis was finally approved for the prevention of stroke in patients with atrial fibrillation on December 28, 2012.
On March 14, 2014, Eliquis gained additional approval by the FDA for the prevention of blood clots in the legs and lungs in patients that had recently undergone knee or hip replacement surgeries.
Finally, On August 21, 2014, the FDA approved Eliquis for the treatment of deep vein thrombosis and pulmonary embolism, two severe types of blood clots.
The package insert and prescribing information for Eliquis list a number of adverse reactions that may occur when taking the medication. The most common and most dangerous of these are internal bleeding of the gastrointestinal tract, and cerebral hemorrhaging, which are discussed below.
Other more common side effects associated with Eliquis during clinical trials include:
If you experience any of these side effects while taking Eliquis, it is important to talk with your doctor. However, it is not recommended that you stop taking Eliquis without direction from your doctor to do so.
Blood thinning drugs are designed to inhibit the body’s natural tendency to form blood coagulation, in order to prevent clots and stroke. However, this can cause the unwanted and dangerous side effect of internal bleeding.
While all the major brand-name blood thinners contain fine print warnings that internal bleeding can occur, they also claim they are safer that traditional anticoagulants, with fewer bleeding side effects.
In the case of Eliquis, the manufacturer failed to inform consumers that it is only slightly better at causing most internal bleeding than other medications, and even more likely to cause some types (see below).
Also, the traditional anticoagulant warfarin has a tried-and-tested antidote that can be used in emergencies to stop bleeding. Eliquis does not have an FDA-approved bleeding antidote. The manufacturer doesn’t fully inform patients that, in cases of emergency bleeding, the only current treatment is to discontinue use and wait for bleeding to stop on its own.
So far, the FDA has received at least 661 adverse event reports concerning Eliquis patients suffering internal bleeding, and at least 111 reports of patient death. And, experts estimate less than 25% of these side effects are actually reported to the FDA.
BMS and Pfizer have advertised Eliquis as a medication that is more effective than warfarin at preventing stroke and blood clots, while having fewer occurrences of internal bleeding. However, studies show this isn’t entirely accurate.
In a clinical trial involving more than 9,000 patients, Eliquis was slightly more effective at preventing strokes and blood clots than traditional medication warfarin. However, it caused almost as many overall bleeding events, and even more of one specific type.
In the manufacturer’s own studies, more than 2% of patients taking Eliquis experienced a major bleeding incident, which includes gastrointestinal bleeding, cerebral hemorrhage or bleeding death. This was compared to a rate of over 3% of patients taking warfarin.
The majority of these bleeding events occurred in patients over the age of 65, who were taking the 5 mg dose.
However, in the cases of intraocular bleeding (bleeding of the eye), those patients taking Eliquis were approximately 50% more likely to suffer the side effect as those taking warfarin.
Also, a new report indicates FDA experts have raised questions about the true benefit of Eliquis over other medications as a large portion of data was missing from the clinical trial.
In recent years, nearly 10,000 patients and families have filed lawsuits against the makers of Pradaxa and Xarelto for internal bleeding injury or death. So far, more than $650 million has been awarded to victims.
Now, lawyers have begun investigating cases against the makers of Eliquis as well. This year, the first lawsuits were filed on behalf of a widow whose husband died of major gastrointestinal bleeding, and a man who suffered a severe brain hemorrhage.
Sadly, legal experts believe this is just the start of the litigation, as thousands more may eventually come forward for help after being hospitalized or losing a loved one.
Recent lawsuits have also alleged that the makers of Eliquis altered or concealed clinical data on its bleeding side effects in order to make it appear safer than it really is. If this is proven to be true, millions of people may have been put at risk.
For more information on the studies, warnings and side effects of Eliquis, or to speak with a lawyer about a claim, contact DrugNews today.
Bleeding after Eliquis? Speak with a lawyer who specializes in the Eliquis litigation.
Thank you for contacting DrugNews. Your inquiry has been forwarded to one of our Patient Advocates. A representative should be in touch with you in less than 24 hours but hopefully much sooner.
For immediate information, you can reach us on our 24/7 Defective Drug Hotline at 1-888-391-1315.
Oops! Something went wrong while submitting the form :(