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Some bottles of the anticoagulant Eliquis are being recalled, due to a risk that they may contain pills with a different dosage than that on the label, which may increase the risk of severe bleeding problems or leave individuals unprotected against the risk of a clot the drug was prescribed to prevent.
The Eliquis recall was announced by the FDA and Bristol-Myers Squibb on June 10, after at least one customer found that a bottle labeled as Eliquis 5 mg actually contained 2.5 mg tablets.
While there have been no reported illnesses or injuries linked to the mislabeled bottles, taking the wrong anticoagulant dose could have serious consequences.
The manufacturer warns that patients who are taking Eliquis to prevent stroke or pulmonary embolism due to an irregular heartbeat, known as atrial fibrillation, are at an increased risk of stroke, fatal blood clot, or death, if they take only 2.5 mg when they were supposed to take a 5 mg dose.
If other bottles were distributed with 5mg pills instead of 2.5mg, users could be at an increased risk of severe bleeding problems from Eliquis.
The pills have been designed to be visually different, in order to prevent dosing errors. The 2.5 mg pills are yellow, round, biconvex, and have “893” debossed on one side and “2 1/2” on the other. The 5 mg pills are pink, oval, biconvex and have “894” debossed on one side and “5” on the other.
The recall affects one lot of Eliquis 5 mg tablets, which were packaged in 60-count bottles. They have a lot number of HN0063, an NDC code of 0003-0894-21, and an expiration date of 09/2019. They were distributed nationwide in February 2017.
The manufacturer has notified wholesalers and pharmacies to pull the affected bottles from shelves and recommends customers contact their doctor and call the Bristol-Myers Squibb Customer Information Center at 1-800-332-2056.
Eliquis Bleeding Problems
Eliquis is part of a new crop of oral anticoagulants introduced in recent years, which also includes the other blockbuster treatments Xarelto and Pradaxa.
The drugs have been aggressively marketed as a replacement for Coumadin (warfarin), which has been the go-to anticoagulation treatment for decades. However, unlike warfarin, where the blood thinning effects of the medication can be reversed in an emergency to stop bleeding problems, there was no approved reversal agent when Eliquis, Pradaxa or Xarelto were introduced.
About 80 Eliquis lawsuits filed in U.S. District Courts nationwide have been centralized before U.S. District Judge Denise L. Cote in the Southern District of New York as part of a federal MDL, or multidistrict litigation.
Each of the plaintiffs indicate that the side effects of Eliquis caused them to suffer severe or fatal bleeding problems, alleging that the drug makers withheld information about the lack of an antidote to reverse the blood thinning effects of the drug, and failed to provide proper recommendations regarding monitoring to maintain a safe dose.
Similar MDL proceedings have previously been established for all Pradaxa lawsuits and Xarelto lawsuits, which raised nearly identical allegations about the same risks associated with these other new-generation anticoagulants, which hit the market before Eliquis was introduced.
Following several years of litigation over the failure to warn about the bleeding risk with Pradaxa, which was the first member of this class of drugs to enter the market, Boehringer Ingelheim agreed to pay $650 million in Pradaxa settlements to resolve about 4,000 cases in 2014.
The Xarelto litigation is currently centralized in the federal court system, where about 18,000 complaints are pending before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana, with the first of a series of early “bellwether” trials currently underway.