WARNING: Xarelto Linked to Fatal Internal Bleeding, No Reversal Agent
Recently, the anticoagulant drug Xarelto (rivaroxaban) has come under increased scrutiny by both the United States Food and Drug Administration and medical professionals alike, citing an increased risk for internal bleeding. Unfortunately, there is as yet no reversal agent for the drug.
Due to inadequate warning labels on Xarelto packaging, manufacturer Bayer Pharmaceuticals, Inc. faces a number of pending Xarelto lawsuits. Today, Xarelto is the second most commonly prescribed blood thinning drug in the US, behind Coumadin (warfarin), with about four million prescriptions filled annually.
Broadly, it is alleged that Xarelto warnings downplay the risk for internal bleeding associated with the drug and the class of medication. Lawsuits also allege that the Xarelto Black Box Warning leads doctors and patients to believe that the drug is safer and more effective than warfarin which it is not.
Furthermore, Xarelto is marketed as an anticoagulant that does not require regular blood tests, as warfarin does. (Xarelto commercials often depict active adults travelling or even driving race cars, unhindered by the rigor of frequent blood work.) This marketing is very dangerous, and I’ll explain why.
Unlike some other drugs, Xarelto is metabolized at highly variable rates among patients. Some people metabolize the drug in a day, others might metabolize a dose in three. Therefore, only knowing the dose a patient took, determining the amount of Xarelto in a patient’s blood at any given point is difficult. This is important because Xarelto has a particularly narrow “therapeutic window,” meaning that there is a small range of Xarelto concentration in the blood that is helpful: too much can cause internal bleeding and too little can leave patients at risk for stroke. Knowing the specific amount of Xarelto in your blood at any given time is important so your doctor can make dose adjustments and keep you in the therapeutic window.
Conclusion: Regular blood tests when using blood thinning drugs are vital, and marketing a blood thinning drug as one that doesn’t require regular blood testing is dangerous. Recently, the British Medical Journal reported that even annual blood tests could reduce the risk for internal bleeding by 40%.
Here are some helpful links regarding Xarelto:
FDA Safety Communications Regarding Xarelto
Xarelto Safety Information (from Manufacturer)
Xarelto Safety Information (Does Not Mention Rate of Major Bleeding Events)
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