Anti-Coagulation Medications May Cause Serious Side Effects

Anti-coagulation lawsuits have been filed against the makers of certain anti-coagulation medications alleging the makers of those medications did not carry adequate warnings about the risks of anti-coagulation side effects. Side effects associated with certain blood thinners include an increased risk of life-threatening uncontrolled bleeding.

Anti-coagulation medications (also known as blood thinners) are used to prevent blood clots, which can result in deep vein thrombosis, pulmonary embolism and stroke. Because they prevent blood from clotting, however, patients may develop uncontrolled bleeding—including internal bleeding—from minor injuries. The longest-used blood thinner is Warfarin, known by the brand name Coumadin.

Like newer-generation anticoagulation medications, warfarin has been associated with an increased risk of uncontrolled bleeding. Unlike newer anticoagulation drugs, however, warfarin has an antidote, so patients who develop bleeding problems and seek medical attention may have the effects of warfarin reversed.

Among the medications that are included in the class of anticoagulation drugs are Pradaxa, Xarelto, Zontivity, Eliquis and Savaysa.

Newer-generation anticoagulation medications may also be associated with an increased risk of uncontrolled bleeding. Unlike warfarin, they do not currently have an accepted antidote meaning patients who suffer a bleeding event may not be able to reverse the effects of the event, potentially creating a life-threatening situation. Some of these medications have been marketed as easier to use than warfarin because their makers claim patients do not require blood level monitoring.

Lawsuits filed against the makers of some anticoagulant drugs allege either that the drug did not carry an adequate warning about the risks or that the drug was marketed as superior to warfarin when there was no antidote.

Pradaxa's label does carry a warning about the increased of bleeding events in patients. Some concerns have been raised, however, that Pradaxa was marketed as being superior to warfarin, even without an antidote.

The Pradaxa label does include a warning about the increased risk of bleeding events in patients. The concern, however, is that Pradaxa was allegedly marketed as being superior to warfarin even though there was no antidote to the uncontrolled bleeding.

In May 2014, Boehringer Ingelheim announced a $650 million settlement to resolve around 4,000 lawsuits alleging patients were seriously harmed by the use of Pradaxa.

Xarelto has also been reportedly linked to an increased risk of bleeding side effects. Lawsuits have been filed against the maker of Xarelto, but as of August 2014 fewer than 10 lawsuits have been filed.

In 2014, Johnson & Johnson and Bayer announced that the FDA sent a complete response letter regarding Xarelto, rejecting the companies' application to expand the use of Xarelto to include new indications. The FDA had previously rejected other applications to expand the use of Xarelto as well.

Attorneys expect that more Xarelto lawsuits will be filed alleging patients were not properly advised of the risks associated with the medication.

Other newer-generation anti-coagulant medications include:

• Eliquis (Apixaban)
• Lovenox (Enoxaparin Sodium)
• Arixtra (Fondaparinux)
• Savaysa (Edoxaban)

Zontivity, known generically as vorapraxar, is a new drug approved for use in 2014. Early trials of the drug were reportedly changed and one trial was reportedly stopped prematurely because the trials suggested an increased risk of severe bleeding or intra-cranial hemorrhage (bleeding). According to the FDA, the drug will carry a boxed warning concerning the risk of intra-cranial hemorrhage.

The Alere INRatio and INRatio2 PR/INR Professional Monitoring Systems are used by healthcare professionals to monitor the effects of warfarin on a patient's clotting time. The systems determine the International Normalized Ratio (INR) of the patient's fresh capillary whole blood, which shows how quickly the patient's blood clots.

On December 8, 2014, Alere announced a class 1 recall in the form of a correction letter, warning that certain medical conditions should not be tested with the INRatio and INRatio2 systems. In its announcement, Alere noted that some medical conditions might result in incorrect results, specifically, inaccurately low INR results. Conditions include anemia with hematocrit less than 30 percent, conditions with elevated fibrinogen levels, chronic inflammatory conditions or severe infections. Inaccurate INR results could lead to a doctor not making necessary warfarin dosing changes, putting the patient at risk of a bleeding event.

Patients on certain anticoagulant medications require regular testing to ensure their blood maintains its ability to clot in the case of injury. Doctors who do not provide adequate testing for patients who require it may be liable for medical malpractice if their patient suffers an uncontrolled bleeding event.

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Last updated on Jun-18-15