Xarelto is a blood thinning medication that helps prevent blood clots and the complications they can cause. The drug was approved by the US Food and Drug Administration in 2011, and is manufactured by Bayer Pharmaceuticals and marketed in the United States by Janssen Pharmaceuticals, a division of Johnson & Johnson. Frequently prescribed by doctors, not to mention advertised by well-known celebrities, Xarelto is linked to a number of serious side effects and was responsible for the deaths of several users.
Xarelto Replaces Warfarin
Prior to the development of Xarelto, clotting risk was treated with a drug known as warfarin. This anticoagulant has been on the market for more than six decades and is considered relatively safe. There are risks associated with warfarin, but there are treatments available that usually prevent risks from developing into serious medical concerns.
The downside of warfarin is it requires a great deal of monitoring by a patient’s doctor. Warfarin users must monitor their blood on a daily basis and dosages must be adjusted frequently. Xarelto was developed to treat the same issues – clotting, deep vein thrombosis, and pulmonary embolisms – but did not require the same attention as warfarin. The new medication could be taken in pill form once or twice a day, making treatment far more convenient for users.
Xarelto was not without criticism, even before the risks associated with the drug were discovered. Xarelto costs approximately $3000 annually, whereas the generic warfarin is only $200. The cost has not deterred users, though, and the sales of Xarelto are expected to exceed $3 billion per year by 2018.
Adverse Events Caused by Xarelto
As easy as Xarelto makes it to use a blood thinner, it is not without risks. The primary concern with Xarelto is that, unlike warfarin, there is no antidote to stop bleeding, should a bleeding event occur. Instances in which a Xarelto user experienced just a minor cut resulted in serious and unstoppable bleeding because medical professionals were unable to get bleeding under control.
The risk for uncontrolled bleeding events became public in September 2013 when medical officials in Germany announced the drug had been linked to 72 deaths and more than 750 complications. Within a year legal action regarding Xarelto began in the United States.
In response to the issues arising from Xarelto use, the FDA issued a warning letter to Johnson & Johnson in June 2013 regarding the company’s false advertising claims about the drug. It called Xarelto advertising false or misleading because it minimized risks and made the claim that no monitoring or dosage adjustments were needed when taking Xarelto. The FDA was so concerned about the risks associated with the drug it issued a requirement for its most stringent warning – a black box warning – outlining the side effects of Xarelto and requiring the drug’s manufacturer to include the warning on the box.
Legal Action Related to Xarelto
Many Xarelto users have taken legal action against Bayer, Johnson & Johnson, and Janssen Pharmaceuticals. The claims include allegations Xarelto has no antidote to stop uncontrolled bleeding. There have been instances in which Xarelto users bled to death after only a minor cut. When warfarin users experience uncontrolled bleeding they are given vitamin K, but this treatment has been unsuccessful for Xarelto users.
According to the claims made in the lawsuits, the manufacturers and distributors of Xarelto were aware of this risk and withheld the information from the FDA so the drug could still receive approval. Healthcare providers recommended and consumers decided to use Xarelto without realizing they were at risk for serious bleeding events that had no antidote and could prove fatal.
What’s on the Horizon in Xarelto Litigation?
Litigation for Xarelto was recently delayed by US District Judge Eldon E. Fallon who is presiding over the case. One bellwether trial was originally scheduled to begin in early February, but is not expected to take place in mid-March. A second bellwether trial has also been postponed from mid-March to late April.
There are currently more than 3000 Xarelto cases consolidated in MDL and another mass tort program was recently created in Pennsylvania that includes 600 cases. Those involved expected those bellwether trials to begin late this summer, but there has been no official date set.