Pharmaceuticals have the ability to manage disease and save lives, but all prescription medications carry some risk of side effects. When Big Pharma fails to warn consumers about serious health risks associated with their products or negligently conceals side effects in order to increase sales, patients have the right to seek legal compensation.
According to allegations leveled in hundreds of lawsuits filed against Bayer and Janssen Pharmaceuticals, the blood thinner Xarelto (rivaroxaban) was marketed without sufficient labeling regarding internal bleeding dangers. Moreover, doctors have no antidote or reversal agent to treat Xarelto hemorrhages, leaving patients at risk for life-threatening injury and death.
If you or someone you love has suffered adverse effects from Xarelto bleeding, we invite you to schedule a case review with Los Angeles personal injury lawyers at Nadrich & Cohen. We leverage decades of experience litigating dangerous drug cases and have the resources and skill to achieve justice and fair compensation for our clients.
Xarelto bleeding risk
Xarelto, a direct factor Xa inhibitor, hit U.S. shelves in 2011 and quickly became a best-seller for Bayer and Janssen. The anticoagulant was heavily advertised as a more convenient alternative to warfarin, which required regular blood tests and more cumbersome dosage adjustments.
Rivaroxaban helps to stop blood clots from forming in patients with non-valvular atrial fibrillation (AF), and those who have recently had knee or hip replacement surgery. Xarelto is also used in patients with deep vein thrombosis and pulmonary embolus to prevent dangerous blood clots from developing.
However, compared to other blood-thinning drugs, Xarelto has been linked to higher risks of fatal bleeds, including gastrointestinal hemorrhages for which there is no antidote. 2015 research published in the British Medical Journal found that patients treated with Xarelto had a 50 percent greater risk of uncontrolled bleeding episodes. The two-year study took a closer look at bleeding risks posed by Pradaxa, Xarelto, and Warfarin. After analyzing 46,000 patients, researchers determined that patients had a higher risk of developing a Xarelto GI bleed compared to other anticoagulants.
Rivaroxaban has been linked to the following injuries:
- Gastrointestinal bleeding
- Xarelto heart failure
- Cranial hemorrhage
- Uncontrolled internal bleeding
- Spinal epidural hematoma
Researchers found that life-threatening GI bleeding episodes among Xarelto patients were more prevalent among those who took larger doses over prolonged periods.
Xarelto bleeding symptoms
Symptoms of Xarelto internal bleeding do not manifest immediately in all patients. In general, early warning signs may include:
- Distended stomach/abdominal pain
- Bloody stools
- Bleeding from the gums or nose
- Pink, brown or red urine
- Vomiting blood
- Unusually pale skin
- Easy bruising
- Anemia, or low blood cell count
Xarelto bleeding precautions
Health regulators offer several precautions for patients taking rivaroxaban. Because the drug is known to cause bleeding problems, patients are advised to:
- Have routine blood tests to check for adverse side effects
- Avoid rough contact sports
- Limit alcohol intake
- Do not become pregnant
- Be mindful of drug interactions with SSRIs, antifungals and certain antibiotics
- Discuss dosage with doctors in case of acute renal impairment
- Lower dosage before Spinal/Epidural Anesthesia or Puncture
Xarelto bleeding treatment
Reversal agents are used to stop the anticoagulant effects of blood thinning drugs. In the case of Warfarin, doctors can administer therapeutic doses of Vitamin K to stop uncontrolled bleeding. The FDA also recently approved an antidote for Pradaxa bleeding events which can be used in emergency situations. However, there is no universal treatment to control Xarelto bleeding. When patients develop dangerous GI or brain bleeds, physicians may attempt blood transfusions as a last resort.
Is there a Xarelto antidote?
Unfortunately, health regulators have yet to approve a Xarelto bleeding reversal agent. In 2016, Portola Pharmaceuticals developed a new Breakthrough Therapy drug known as AndexXa (andexanet alfa) that was slated to be the first antidote for bleeding events triggered by Eliquis and Xarelto. Ultimately, the FDA turned down the drug based on lack of manufacturing data and Portola’s post-marketing commitments.
Xarelto deaths from internal bleeding
In the first part of 2013, Bayer confirmed at least 72 deaths attributed to Xarelto-related bleeding. In 2012, some 58 Xarelto patients succumbed to fatal bleeding events. Dozens of families who lost loved ones to Xarelto brain and GI bleeds have taken their claims to court, and are suing for the wrongful death of their fathers, mothers, grandparents, and siblings. Bayer stands accused of manufacturing and marketing a dangerous drug without proper warnings.
Currently, more than 2,800 Xarelto injury lawsuits have been brought against Bayer and Janssen Pharmaceuticals. Litigation has been consolidated under multidistrict litigation (MDL) No. 2592 in Louisiana District Court, as well as a mass tort in the Philadelphia Court of Common Pleas.
Can you just stop taking Xarelto?
According to the Xarelto Warnings and Precautions label, patients should not stop taking the drug as premature discontinuation of any blood thinner – in the absence of other anticoagulation treatment – augments the risk of thrombotic events and stroke.
The FDA also mandated a Xarelto black box warning, cautioning patients about spinal hematoma risks following a spinal puncture procedure in those who immediately discontinue Xarelto.
The product liability attorneys at Nadrich & Cohen are offering complimentary legal consultations to those who suffered injury or hospitalization due to Xarelto bleeding.
For compassionate, personalized representation with a highly-credentialed firm, please call us at 1-800-718-4658.