San Diego, CA — August 27, 2015
Since it’s introduction, Xarelto’s run on the blood thinner market has been riddled with several lawsuits alleging that the drug causes serious side effects including development of blood clots, pulmonary embolism, and uncontrollable internal bleeding. The FDA has attached two black box warnings to the drug, the most strict warning handed out to a drug.
New Clinical Guidelines
Recently, new guidelines have been released where doctors warn that patients with serious kidney problems should not be taking Xarelto due to the risk of blood clots, stroke, and excess bleeding. The American College of Cardiology, The American Heart Association, and the Society of Thoracic Surgeons have all teamed up to develop treatment guidelines for patients who need to be medicated with blood thinning drugs.
The groups collectively advised that when patients are diagnosed with chronic kidney disease, “warfarin should be used.” They noted that warfarin is to be used in cases where the patient receives hemodialysis or those who are in serious stages of kidney failure. They also stressed that while blood thinners like Xarelto can be used in patients with moderate to severe CKD, they should not be used in patients with end-stage CKD.
Using blood thinners in patients with CKD, or chronic kidney disease, requires doctors to be cautious because these specific patients have an increased risk of developing blood clots and bleeding problems. Adding Xarelto to the mix can cause complications because when the kidney’s aren’t functioning properly, they aren’t capable of processing drugs normally and flushing them totally out of the system. This can result in too much of the drug being in the body at once, which increases the risk for an internal bleeding complication.
No Drug Reversal for Xarelto
When Xarelto was released onto the market in 2011, Bayer AG and Jannsen Pharmaceuticals marketed the drug as an easier alternative to warfarin, with a “one size fits all” method of dosing and the simple blood testing and dietary restrictions required for success. However, the manufacturers failed to warn doctors and patients that, unlike warfarin, Xarelto doesn’t have an antidote to reverse its effects. Because of the lack of antidote, a patient taking Xarelto who suffers from an internal bleeding event has no way to stop the bleeding. This could lead to serious injury for the patient.
In a 2015 study, it was revealed that blood monitoring in patients taking Xarelto would have been helpful in assessing a patient’s risk for excessive bleeding, despite the fact that the drug’s manufacturer claimed this step wasn’t necessary.
If you or a loved one have been prescribed Xarelto, talk to your doctor before completely stopping this drug.