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More Trouble with Xarelo Clinical Trials

Xarelto has come under a lot of fire lately, as thousands of people have developed a deadly internal bleeding disorder after taking the anticoagulant, and more than 60 people have died. The basis of these claims are that the makers of Xarelto, Bayer and Janssen (a division of Johnson & Johnson), designed a defective drug and failed to adequately warn plaintiffs of a danger about which they knew or should have known.

pillsXarelto is a member a relatively new class of drugs known as New Oral Anticoagulants (NOACs), which were designed to compete with traditional blood thinning medications such as Coumadin (Warfarin). Warfarin is a blood thinner that is prescribed to many patients who suffer from a serious medical condition know as atrial fibrillation (Afib). Afib is basically an irregular heartbeat, which can lead to the formation of clots in the deep veins of the legs. If the clots break free, they can travel through the body until they puncture the lungs or cause a stroke if the blood supply to the brain is blocked. When a clot punctures a patient’s lung, this is known as a pulmonary embolism (PE).

While Warfarin works by thinning the blood, NOACs are designed to stop clots from forming through a more direct action. The advantage to Xarelto is that it is not as hard to control the dose, and there are supposed to be fewer side effects. The problem is that the drug can cause a serious internal bleeding condition that is irreversible and can lead to serious illness or death.

We now know that the drug company did not do enough testing to establish and did not disclose what data they had provided to the United States Food and Drug Administration (FDA). To correct this and also to gain even more of the market share, Bayer is now engaging in large-scale clinical trials with Xarelto. However, according to a recent article from Reuters, one of the major studies involved the use a medical device that has been shown to be defective. The device in question is a blood clotting test device known as an international normalized ration (INR) device.

This means that the results of the clotting tests are called into question as being potentially invalid, since the testing device was defective. The further problem is that regulators may want to scrap the entire results due to the defective piece of equipment, while Bayer is arguing that benefits of Xarelto should be published based upon the study, since it was only one testing device use. However, the European Medicines Agency (EMA), a European FDA counterpart, is requiring a full investigation with independent testing to see if Xaretlo is defective. While the company is not happy with all of the Xarelto injury lawsuits already filed, there is no surprise that the drug is under more scrutiny.

Bayer is trying to use data from Duke University, where the defective test device was used, to show that the defective product did not affect the validity of the study. With the long history of drug companies trying to hide results from the FDA and the general public, it seems clear that financial gain is of often a higher priority than patient safety.

If you are a victim Xarelto victim and live in Massachusetts, call the Law Offices of Jeffrey S. Glassman for a free and confidential appointment — 1-888-367-2900.

Additional Resources:

Trial for Bayer drug Xarelto under scrutiny over defective device, December 9, 2015, Reuters, By Ludwig Burger

More Blog Entries:

Risk for Internal Bleeding after Taking Pradaxa, August 22, 2014, Boston Dangerous Drugs Injury Lawyer Blog