History of Xarelto

History of Xarelto

March 4, 2017 Drugs Information 0

Xarelto is a blood thinning drug meant for use in people with a variety of conditions, including those who have undergone hip or knee replacement, those with atrial fibrillation, those with a risk of pulmonary embolism, and more. The history of this prescription medication – produced by Johnson & Johnson and Bayer, has become rather controversial as many patients have experienced severe side effects. Thousands of lawsuits have been filed by past patients and their families, and many more are expected to follow. Despite all of the controversy surrounding this drug, it actually has a relatively short history.

A Timeline

The drug rivaroxaban – sold under the brand name Xarelto – was first submitted for FDA approved in 2008. Bayer is credited as having invented this new drug while operating under a joint development agreement between Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development. The development of this medication was notable in the healthcare industry, as a new oral anticoagulant had not hit the market in the United States in more than 50 years.

Three years after it had been submitted, approvals for Xarelto began to roll in from the FDA. In 2011, the drug was approved for use in preventing deep vein thrombosis for patients who had recently undergone a hip or knee replacement operation. Also in 2011, the drug was approved for people with an abnormal heart rhythm, with the goal of preventing stroke. A year later, in 2012, Xarelto gained another approval, this one authorizing the use of the drug to treat and reduce the recurrence of blood clots. Despite a variety of issues in the years since these approvals were granted, the drug Xarelto remains approved by the FDA for use in the United States.

The Rocket-AF Trial

Any discussion of the history of Xarelto would be incomplete without a look at the controversial Rocket-AF trial. Any new drug to hit the market needs to be tested in clinical trials, and the biggest trial related to Xarelto was the so-called Rocket-AF trial. This trial pitted Xarelto against warfarin, a commonly prescribed anticoagulant which has been on the market for some time. The trial would eventually conclude that Xarelto offered a similar efficacy to warfarin, however those results have been called into question since the completion of the trial.

To understand this trial, it is important to understand how each medication is to be administered. With warfarin, the dosage is to be adjusted periodically by a physician who tests each patient and tweaks the prescription as necessary. With a goal of keeping the patient in the range between 2-3 for international normalized ratio – or INR – doctors use a device to test INR and then add or subtract medication to keep the patient in the right zone. When Xarelto is used instead of warfarin, this testing is not necessary. The doctor prescribes a specific dosage to be taken once daily and the patient simply continues with that level of medication. No INR testing is completed, and the dosage is not tweaked periodically. This was praised as one of the advantages of taking Xarelto, as patients could avoid trips to the doctor for testing.

Unfortunately, it is that INR testing which has called into question the results of the Rocket-AF trial. The INR devices used in the trial have since been recalled and deemed inaccurate, meaning the patients on warfarin within the trial may have been given the incorrect dosage. With the devices registering lower-than-actual INR levels, doctors may have been prescribing too much warfarin during the trial. Obviously, the administration of too much medication could have altered the final conclusions drawn from the study. The questions surrounding the validity of this trial led the FDA to have doubts as to whether or not Xarelto should be approved for sale to the public. There was disagreement among members of the advisory board before the drug was finally approved.

The Lack of an Antidote

In the years since Xarelto was approved, there have been many patients who have been harmed by side effects related to the use of this drug. As a result, more than 2,000 lawsuits have already been filed against the drug’s maker. One of the many issues which has been highlighted during legal action is the lack of an antidote for the medication. With no antidote available to reverse side effects when they become serious, patients are at risk of serious injury or death if something goes wrong while on Xarelto.

Due to the number of health problems experienced as side effects to Xarelto – most notably, uncontrolled bleeding events – the FDA required the addition of a ‘Black Box’ to the Xarelto packaging in 2014. This warning clearly indicates to patients that there are significant risks associated with taking this drug. Although the drug remains on the market, the addition of this warning is a sure sign that the dangers of using Xarelto are not to be ignored.

If you or someone in your family has been harmed by side effects from taking Xarelto, you may wish to take legal action. Patients who have been injured by this drug may be entitled to damages, although there is no guarantee of financial gain when a lawsuit is filed. Whether you have lost wages and incurred medical expenses due to Xarelto, or you have been permanently injured from severe side effects, legal action may be the proper recourse.