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The controverisal new-generation blood thinner Eliquis does reduce the risk of venous thromboembolism among cancer patients, according to the findings of a recent study, but it also places patients at an increased risk of serious and potentially life-threatening bleeding problems.
In findings published earlier this month in the New England Journal of Medicine, Canadian researchers report that giving Eliquis to cancer patients cut the risk of certain types of potentially blood clots by more than half, but major bleeding events occurred in twice as many individuals given a placebo.
Researchers conducted a controlled, double-blind clinical trial on the efficacy and safety of Eliquis (apixaban), which is a member of a new-class of anticoagulants known as Factor Xa inhibitors, which also include Pradaxa and Xarelto. In the study, Eliquis was evaluated as a preventative measure for venous thromboembolism among ambulatory cancer patients with an intermediate to high risk of blood clots undergoing chemotherapy.
The study involved 563 patients in a modified intention-to-treat analysis, 288 of whom were given Eliquis and 275 of whom were given a placebo.
According to the findings, 12 of the 288 patients, or 4.2% given Eliquis suffered a venous thromboembolism. That compares to 28 of the 275 patients, or 10.2%, given a placebo. However, major bleeding events occurred in 10 of the Eliquis patients, compared to only five patients in the placebo group.
“Apixaban therapy resulted in a significantly lower rate of venous thromboembolism than did placebo among intermediate-to-high-risk ambulatory patients with cancer who were starting chemotherapy,” the researchers concluded. “The rate of major bleeding episodes was higher with apixaban than with placebo.”
Eliquis Bleeding Risks
Since the new-generation drugs have hit the market in recent years as a replacement for the older anticoagulation treatment warfarin, reports of severe and fatal bleeding problems with Eliquis, Xarelto and Pradaxa have surfaced nationwide. In many cases, the events were linked to a lack of an effective antidote to reverse the blood thinning effects of the drug, leaving doctors unable to control or stop bleeds.
Thousands of Eliquis lawsuits, Xarelto lawsuits and Pradaxa lawsuits have been filed in recent years, each raising similar allegations that the manufacturers failed to adequately warn about the bleeding risks and lack of a reversal agent.
Pradaxa was the first member of the class to hit the market, and the manufacturer previously agreed to pay more than $650 million in Pradaxa settlements in 2014, which resolved about 4,000 cases.
Bayer and Johnson & Johnson are currently facing more than 20,000 lawsuits raising similar allegations over the bleeding risks with Xarelto, which has become the most widely used member of the class. A handful of cases have gone to trial with mixed results, and the drug makers continue to maintain that it will defend individual claims and has refused to negotiate a settlement of the litigation.
In contrast, Bristol-Myers Squibb and Pfizer have largely escaped liability for failure to warn about the side effects of Eliquis, after a federal judge appointed to preside over the litigation granted the drug makers motion to dismiss lawsuits early in the litigation.