Posted in Drug & Medical Devices on August 13, 2014

After the recent multi-million dollar Pradaxa lawsuit settlement, patients who suffered a bleeding injury while taking the anticoagulant Xarelto may wonder if they have a legal claim.

For more than 50 years, patients with an abnormal heart rhythm known as nonvalvular atrial fibrillation (AFib not due to valve problems) used a blood thinner called warfarin  to reduce the risk of stroke. While effective, patients taking warfarin had to undergo extensive monitoring to insure safe administration of the medication.

In recent years, a number of new oral anticoagulants (NOACs) have hit the market, each promising to provide the same health benefits—but without the testing required by warfarin (Coumadin). However, unlike warfarin, these blood thinners do not have an antidote. Therefore, in cases of severe, sometimes life-threatening bleeding, patients are left to wait until the body slowly filters the drug from their system.

$650 Million Settlement

The first of the new oral anticoagulants to be approved by the FDA was Pradaxa (dabigatran), which subsequently became the subject of over 4,000 lawsuits filed by patients and their families. They claimed the manufacturer failed to warn consumers Pradaxa caused serious and sometimes fatal bleeding that could not easily be reversed. In May of 2014, German drug maker Boehringer Ingleheim agreed to pay $650 million to settle those claims.

Xarelto may cause fatal bleeding

Now another oral anticoagulant, Xarelto (rivaroxaban), has also been linked to serious side effects. A number of lawsuits have been filed, claiming injuries related to the pill involving severe internal bleeding. While Xarelto is not identical to Pradaxa, a recent study concluded patients treated with both NOACs have an increased risk of gastrointestinal bleeding compared to patients treated with warfarin.

The need for anticoagulants is growing. According to the CDC, nearly 3 million Americans suffer from atrial fibrillation, and experts predict the market for blood thinners could soon exceed $10 billion per year. Although a number of NOAC reversal agents are currently in development, they are likely years away from FDA approval. In the meantime, patients and healthcare professionals should carefully weigh the risks and rewards of taking new oral anticoagulants.

Elk & Elk is no longer investigating Xarelto claims.

Sources:

Holster IL, Valkhoff  VE, Kuipers EJ, Tjwa ET. New oral anticoagulants increase risk for gastrointestinal bleeding: a systematic review and meta-analysis. Gastroenterology 2013; 145(1):105-112.

Husten, Larry. Boehringer Ingelheim Settles US Pradaxa Litigation For $650 Million. Forbes, May 28, 2014.