Why are there
Xarelto (rivaroxaban) is an anticoagulant (blood thinner) that has been linked to an increased risk in severe internal bleeding.
Manufacturers of Xarelto are involved in lawsuits, which argue, that there are no effective means to stop bleeding in users. In the event of an emergency, this can result in hospitalization from
Xarelto has already been linked to numerous deaths since its
approval in 2011.
What is Xarelto?
Classified as a New Oral Anticoagulant (NOAC), Xarelto (rivaroxaban) is one of the newest anticoagulants (blood thinners) on the market. Developed by Bayer Pharmaceuticals and marketed by Johnson & Johnson’s Janssen Pharmaceuticals, Xarelto is an oral medication that belongs to a class of drugs known as Factor Xa inhibitors.
The Food and Drug Administration (FDA), following a fast-track regulatory review, approved the usage of Xarelto to prevent blood clots in patients who suffer from deep vein thrombosis (blood clots deep within the body) and pulmonary embolism (blood clots in the lungs). Xarelto is also used to reduce the risk of stroke in people who suffer from atrial fibrillation (irregular heartbeat).
What are some of the side effects of Xarelto?
There is a moderate range of side effects that patients may suffer from when taking Xarelto. The most common side effects of Xarelto involve bleeding complications.
- Minor side effects vary and can include, but are not limited to:
- Muscle pain
- Muscle spasms
- Bladder or bowel dysfunction
- Internal bleeds
Thousands of Xarelto
Initial lawsuits consisted of plaintiffs who had suffered severe bleeding because of taking Xarelto for just a few months. Many of these cases involved patients who bled to death because of subdural hemorrhaging.
In 2015, the number of cases increased exponentially from a mere 80 cases in January, to over 2,200 by December of that same year. As of September 2016, there are over 10,000 Xarelto lawsuits pending multi-district litigation.
Pradaxa, the drug’s predecessor, was also involved in thousands of claims that led to $650 million dollars in settlements.
History of Xarelto
Prior to the development and FDA approval of Xarelto (rivaroxaban), Warfarin was considered the gold standard for preventing blood clots from as far back as the 1950’s.
Despite its efficiency, Warfarin was deemed difficult to use as it required dietary restrictions and consistent blood testing. Xarelto was marketed as a better alternative as there were no dietary restrictions or regular lab testing associated with its use.
In 2011, the FDA approved the use of Xarelto as a new blood thinner on the market designed to reduce the risk of blood clots associated with deep vein thrombosis (DVT) and pulmonary embolism (PE).
Studies on Xarelto
The Food and Drug Administration (FDA) found systematic errors in half of the clinical trial sites for Xarelto. The inspection warranted regulatory action and Xarelto received the most severe rating from the FDA.
The FDA found a number of issues with the clinical trials including:
- Discarding of medical records
- Unauthorized unblinding
- Improprieties in randomization
The clinical trials and corresponding study were deemed unreliable by the FDA.