New Blood Thinners’ Benefits Doubted

New Blood Thinners’ Benefits Doubted | Pintas & Mullins Law Firm

Eliquis is one of four new anticoagulant, or blood thinning, drugs on U.S. markets. These drugs (Xarelto, Pradaxa, and Savaysa) are marketed as replacements to warfarin. Warfarin has been the first line treatment for blood thinning since the 1960s. Our team of Pradaxa and Xarelto lawyers examines these new anticoagulants and the false claims their manufacturers are making.

Pradaxa (dabigatran), Eliquis (apixaban), Savaysa (edoxaban), and Xarelto (rivaroxaban) are medically referred to as novel oral anticoagulants (NOACs). Eliquis is the only one of these drugs that claims to reduce deaths in patients with an irregular heartbeat. However, experts at the FDA and elsewhere question the validity of this claim.

In the clinical trial to approve Eliquis, researchers concluded that patients receiving the drug were 11% less likely to die from any cause compared to those receiving warfarin. Very important data was missing from this trial, however, most notably data involving patient deaths.

Most researchers, along with the FDA, accept that a statistical value must be less than 0.05 for it to be considered more significant than chance. Any value equal or over 0.05 indicates that simple chance could account for the difference in outcome.

The statistical value of Eliquis' death "benefit" was reported at 0.0465, or barely enough to be deemed significant. If there was even one more death among the studied patients taking Eliquis, or one less death among the warfarin patients, the mortality benefit would climb above the 0.05 limit.

Information from more than 300 patients was mysteriously missing from the Eliquis trial. The missing data could have been lost during follow-up because the patient had a stroke or died. The problems with the trial and its data destroyed the confidence many FDA reviewers had in Eliquis, despite their desire for more warfarin alternatives.

Unfortunately, even if some FDA reviewers express significant concern about a drug it is quite possible it will be approved anyway, as was the case with Eliquis. So the drug was approved for sale on U.S. markets with a claim that it was superior in preventing deaths, without any type of warning about the data quality problems.

Some FDA reviewers tried to have the data problems included on Eliquis' labels, however this attempt was overruled. Many medical experts now believe the claim that Eliquis prevents more deaths than other blood thinners is premature.

Blood thinners are selling more quickly than any other prescription drug class, expected to reach $15.3 billion in global sales by 2018. Unfortunately, the drugs driving this boom - NOACs - are dangerous and deadly, as they have no antidote. These drugs prevent blood from creating clots that could cause heart attack or stroke. Thinning the blood also prevents it from clotting normally when there is an external or internal injury, a mechanism we need to survive even minor injuries. If the body fails to clot in response to an injury, the patient can bleed out in a matter of hours unless there is an antidote for the blood thinning drug.

The blood thinning effects of warfarin are easily stopped by a dose of vitamin K. NOACs have no such antidote, so if a patient taking Xarelto, Pradaxa, Eliquis or Savaysa suffers a major bleeding event, there is a significantly chance they will fatally bleed-out.

For these patients, external or internal bleeding will continue until the drug leaves the body. Far too many patients are unaware of this severe side effect and agree to take an NOAC without any warning about uncontrolled bleeding. As a result, thousands of patients have filed lawsuits against Pradaxa, Xarelto, and Eliquis' manufacturers.

Our teams of Pradaxa and Xarelto lawyers are currently accepting cases involving serious hemorrhaging and death from these blood thinners. We offer free case reviews and work exclusively on a contingency basis, meaning we do not get paid unless we win our clients a settlement or verdict. We accept clients nationwide.