Xarelto® is a widely known and used blood thinner that is prescribed to patients to prevent blood clots when other medical conditions may exist such as an irregular heartbeat, stroke, or pulmonary embolism.
Lawsuits throughout the country are claiming that the manufacturer, Janssen Pharmaceutical, and the co-marketer, Bayer Healthcare, did not adequately warn patients or medical providers of the risks associated with this prescription medication. The manufacturers are also being accused of making misleading claims about the dosage adjustments.
The drug has been linked to cases where internal bleeding has occurred. Patients claim that if the warnings and risks were clearly laid out, patients may have chosen a different medication to treat their condition. The claims also state that had the risks been clear, patients could have been prescribed the proper medication if internal bleeding were to occur.
When Xarelto® was approved by the FDA in 2011, there was no antidote or reversal medication released with it to reverse the effects and the internal bleeding caused by the drug itself.
A similar blood thinner, known as Warfarin, could have been prescribed to consumers in place of Xarelto®. Should a patient experience side effects from Warfarin, the side effects could be reversed with a dose of vitamin K.
In Xarelto lawsuits, patients claim that the lack of an antidote was not clear. If it were, patients may not have chosen this medication.
In addition to internal bleeding, additional risks and symptoms do exist. Some of the symptoms may be mild while others are quite severe.
Some of the most common side effects of this drug include:
- Difficulty breathing
- Loss of control of movement in the body
- Numbness in the muscles
- Decreased oxygen flow to the red blood cells
- Infections
- Bladder and bowel incontinence
- Rectal bleeding
- Swelling in the lower limbs
- Bleeding in the brain
Medical professionals claim the manufacturer of Xarelto® has yet to provide an effective treatment to handle patients that are experiencing bleeding problems from taking Xarelto®.
It is important for patients who experience the following symptoms to seek immediate medical attention:
- Bleeding on the gums that has not occurred before
- Nose bleeds
- Uncontrolled bleeding
- Coughing up blood
- Black stool
- Red, brown, or pink urine
- Severe headaches with a feeling of faintness
- Vomiting blood
The Institute for Safe Medication Practices mentioned Xarelto® as the tenth most frequent suspect drug in both serious and fatal adverse events.
When Xarelto® was first approved by the FDA in 2011 it was approved to help reduce the risk of pulmonary embolism and deep vein thrombosis in patients after knee or hip surgery.
Later in 2011, the FDA approved Xarelto® to treat patients who experienced irregular heartbeats as a way to help reduce their risk of a stroke.
In 2012, Xarelto® was approved further by the FDA to include the treatment for pulmonary embolism and deep vein thrombosis outside of just the knee and hip replacement surgery window.
Warnings were added to Xarelto® and included:
- A warning that indicated the medication did not have an antidote
- A warning that discontinuing the medication could increase the risk of stroke
- A warning that stopping use suddenly could result in blood clots and thrombotic events
- A warning that the drug may increase the risk of acute pulmonary embolectomy
While the warnings may have been added as of 2013, patients affected by the medication prior to 2013 claim they were not given sufficient warnings.
The FDA has only issued one recall for Xarelto®. This recall occurred in 2014 for microbial contamination in of 13,500 bottles.
XARELTO® CLAIMS
At Hughes & Coleman, we will work with you to evaluate your potential Xarelto® claim.
If you would like to receive a FREE case evaluation, contact the team at Hughes & Coleman today. You may be entitled to compensation for your injuries.
Cases likely to be referred.
Do not stop taking a prescribed medication without first consulting your doctor. Discontinuing a prescribed medication without your doctor’s advice can result in injury or death.