At the end of March, Bayer and Johnson & Johnson, the drug companies that make and sell Xarelto (rivaroxaban), agreed to pay $775 million to resolve more than 25,000 lawsuits alleging the drug failed to provide adequate warning. Possible bleeding risks.
Since 2011 when he was The US Food and Drug Administration (FDA) approved for the first time Using Xarelto to treat blood clots, the drug has been prescribed More than 44 million times In the United States alone. The drug is most commonly used to help prevent blood clots in patients with atrial fibrillation (AF) and for people who have had knee or hip replacement surgery.
When the lawsuits were first filed about five years ago, Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) closely reviewed its label information and determined that it clearly communicated the benefits of Xarelto, according to company spokesperson Sarah Freeman.
Although both Johnson & Johnson And the bayer Refuting claims that the drug did not provide adequate notice about the potentially fatal bleeding risks, the companies decided that settling the claims would be the best course of action in terms of time, resources and ultimately patient care.
“As a healthcare company, we want to spend every moment we can improve life and find new treatments,” Freeman says. “We stand behind Xarelto and are eager and excited moving forward. We continue to support studies that explore the potential of Xarelto to treat new areas of unmet medical need. We remain committed to the millions of patients worldwide who have been prescribed the drug.”
Since drug companies have won six other similar cases that have been brought to trial, some have questioned why these lawsuits have not been challenged in court.
Jansen explained that these claims required their scholars to spend many hours answering questions, and keep them away from their research work, so it was in their best interest to put an end to these legal challenges.
Is the effect of legal action on drug use?
According to Freeman, news coverage of litigation attorneys and plaintiffs soliciting clients with advertisements warning of the potential side effects of Xarelto has led many patients to stop using their prescribed anticoagulant medication. This may have led to serious health outcomes for some individuals.
“Once I started watching these lawyers’ commercials on TV about Xarelto, I wanted to call them and tell them, ‘You’ve scared my patients now about taking these life-saving drugs,'” Lawrence M Epstein, MD, director of the electrophysiology system at Northwell Health in Manhasset, New York. “We know there is a risk of bleeding from blood thinners but the risk of having a stroke is much higher. This is just a harm for patients. This is very upsetting to me.”
Freeman adds, “Patients should not stop taking their medication without talking to their doctor. This is first and foremost the most important thing for anyone taking Xarelto.”
For attorneys representing patients who allegedly sustained injuries, such as internal bleeding from medication, the settlement was fair.
“Litigations like this are an important way for consumers to have a say in drug safety issues,” he says. Brian BarLevin Papantonio, of the Pensacola, Florida, law firm and co-principal counsel of the Multi-District Litigation Plaintiffs Steering Committee, in statement.
The benefits outweigh the risks
The lawsuits also alleged that the manufacturers aggressively marketed the drug as an alternative to warfarin (Coumadin, Jantoven), which has been used for decades to help prevent blood clots.
In the past several years, the Food and Drug Administration has approved a new oral anticoagulant drug – Xarelto (rivaroxaban), Pradaxa (dabigatran)And the Eliquis (apixaban)And the Savissa (edoxaban).
The FDA has concluded that these drugs are either equal to or more effective than warfarin in preventing strokes, with an acceptable risk of bleeding.
If heavy bleeding occurs while taking warfarin, there is a reversal factor: vitamin K. Article published in June 2018 in the magazine drugsIn May 2018, the U.S. Food and Drug Administration approved AndexXa (andexanet alfa), the first and only antidote to reverse bleeding in people taking Xarelto, Eliquis, or Savaysa.
“It is important to understand, however, that most cases of bleeding associated with anticoagulants are not life-threatening; in fact, fatal bleeding is very rare,” wrote cardiologist Ellis Unger, MD, MD Article published in October 2015 on the FDA website. “For all anticoagulants used in atrial fibrillation, we found that the benefit of preventing strokes outweighed the increased risk of bleeding.”
Dr. Epstein says, “I prescribe Xarelto every day and in fact, I take them off Coumadin to put them on these medications.”
Search continues to improve treatment
Atrial fibrillation (AF) is the most common heart rhythm problem in the United States, and is expected to affect more than 12 million Americans by 2030, according to one study. Article published in June 2018 in Journal of the American College of Cardiology. The prevalence of atrial fibrillation increased from 16 to 20 percent among patients hospitalized with acute stroke between 2003 and 2014.
Atrial fibrillation increases the risk of stroke because blood may not pump properly out of the heart, which can cause it to pool and form a clot.
Janssen continues to conduct research to investigate and improve the effectiveness of Xarelto. according to press releasea study presented in 2019 Scientific Session of the American College of Cardiology It was found that patients newly diagnosed with non-valvular atrial fibrillation who took Xarelto had significantly fewer strokes, severe strokes, and fewer stroke-related deaths compared with those taking warfarin.
However, other Research published in September 2018 in The New England Journal of Medicinerevealed that Xarelto did not significantly reduce the risk of developing venous thromboembolism, a condition in which a blood clot forms most often in the deep veins of the leg, thigh or arm.
Xarelto also made headlines as Johnson & Johnson began running TV ads advertising the cost of the drug in an effort to be transparent about pricing. according to Article published on March 29, 2019 by AxiosThe commercials, which began at the end of March, show the list price of Xarelto at $448 per month, but the actual patient payout is between $0 and $47, depending on insurance coverage.