Missy Clyne Diaz  |  March 30, 2015

Category: Legal News

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Blood testThe new and popular blood-thinner Eliquis (apixaban), which is already the subject of lawsuits and controversy over fatal internal bleeding episodes, is now being looked at for two more dangerous side effects — colon cancer and liver injury.

According to nationally syndicated pharmacology experts Joe and Terry Graedon, Adverse Events Inc. — a healthcare informatics company which monitors the FDA’s Adverse Event Reporting System (FAERS), looking for signals of drug problems, in addition to securing insider data from the FDA through the Freedom of Information Act (FOIA) — reported in January 2015 that Eliquis may increase the risk of colon cancer and liver damage.

While the number of cases of colon cancer or liver damage is small — the Graedons did not cite an exact figure — the reports will require “careful follow-up” to ensure there is not a trend developing.

Other complications associated with Eliquis, though no warning of them exists on the drug’s official label, includes heart failure, kidney problems and difficulty swallowing, a condition known as dysphagia, according to the Graedons’ website, PeoplesPharmacy.com.

Eliquis is the third anti-coagulant to hit the market in recent years, along with competitors Xarelto (rivaroxaban) and Pradaxa (dabigatran). Since the 1950s Coumadin (warfarin) was the sole blood-thinner available in the United States.

Pradaxa hit the market first, receiving FDA approval in 2010, followed by Xarelto the next year. Eliquis received FDA approval in 2012.

All three blood-thinners have been widely prescribed to prevent blood clots in patients suffering from atrial fibrillation (arrhythmia of the heart); deep vein thrombosis (blood clots deep within the body); pulmonary embolism (blood clots in the lungs) and stroke.

But unlike Coumadin, Eliquis, Xarelto and Pradaxa have no approved antidote to reverse the blood thinning effects of the medications in the event of an internal bleed. Patients using Coumadin can reverse a bleeding episode with a dose of vitamin K and fresh frozen plasma to reverse the drug’s anticoagulant effects.

Coincidentally, the most common adverse events reported by the new generation of blood thinners include uncontrollable internal bleeding and hemorrhage.

Thousands of product liability lawsuits have been filed against the manufacturers of Pradaxa, Xarelto and Eliquis due to the lack of a bleeding antidote. Patients have accused the drug makers, Boehringer Ingelheim, Bayer and Johnson & Johnson subsidiary Janssen Pharmaceuticals and Bristol Myers Squibb and Pfizer, of manufacturing and selling  dangerous drugs while failing to warn users or the medical community that a reversal agent does not exist.

While Eliquis is the newest of the three next-generation anticoagulants, it is also the one medical professionals know the least about when it comes to reversing bleeding, according to a study published in the Journal of Neurosurgery.

“To date, there are no human studies of reversal agents in patients who require rapid (Eliquis) reversal,” according to the study’s researchers.

Boehringer Ingelheim has reportedly made gains in an antidote to its blood-thinner Pradaxa and is trying to expedite FDA approval process. Bayer and Johnson & Johnson are also working on developing an antidote for Xarelto.

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