Xarelto: Is It Worth the Risk?

xarelto-risk

Since 2011, Bayer HealthCare and J&JPRD have aggressively marketed Xarelto as a better alternative to Warfarin for patients at risk for blood clots. Warfarin has been the go-to drug for blood thinning since the 1950s. In the past 5 years, however, Xarelto has become increasingly popular, with many patients choosing convenience over safety despite its apparent risks.

The biggest health and safety concern for any patient prescribed a blood thinner is uncontrolled bleeding. All blood thinners pose this risk because blood-thinning medications prevent the user’s blood from clotting. Therefore, blood can fail to clot when the patient needs it to.  For decades, a solution to this problem was available to patients. Warfarin, an anticoagulant that thins the blood, has a coagulant counterpart, which causes the blood to coagulate in order to reverse Warfarin’s affects.

Unlike for Warfarin, the FDA has not approved any drug that is effective in reversing the effects of Xarelto. Some pharmaceutical companies are working on this issue but final development and FDA approval may still take years.

Why Was I Prescribed Xarelto If There Is No Way to Stop the Bleeding?

Bayer HealthCare and J&JPRD have pushed hard to promote Xarelto as an efficient and more convenient preventative treatment for conditions that can lead to blood clots, like pulmonary embolism and atrial fibrillation (Afib).

Xarelto’s advertising campaign, since its inception, has highlighted convenience as the main reason to choose Xarelto over Warfarin. Bayer HealthCare and J&JPRD have lauded this as one of the major reasons to drop Warfarin for Xarelto. Xarelto advertising materials feature high-profile celebrities and public figures talking about their busy schedules and how monthly monitoring doesn’t work for them.

Patients on Warfarin need to take INR tests regularly in order to monitor their vitamin K and blood sugar levels. While people traveling city-to-city for work, like celebrities or professional athletes, may find having to be regularly monitored an inconvenience, for the majority of people on this medication regular check-ups are worth the peace of mind. Even for those with very busy lifestyles, the ‘inconvenience’ of monitoring should be judged against the danger of unstoppable bleeding. Xarelto ads clearly state that there is only limited evidence to suggest that it is any more effective than Warfarin in mitigating the risk of blood clots.

Monitoring

The major downside to Warfarin, when compared to new blood thinners, is that monitoring is required. Every 2 to 4 weeks, the patient must get a blood test done in order to determine if his or her blood levels are within the International Normalized Ratio (INR). A patient’s INR levels can be affected by a variety of factors, including a sudden change in the levels of vitamin K in the blood. The blood tests are simple and quick and require little more than showing up at a lab on the designated date.

The monitoring requirement has been the linchpin of Bayer HealthCare and J&JPRD’s marketing and advertising touting Xarelto as a much better alternative to Warfarin. Xarelto and other new blood thinners require no such monitoring.

Vitamin K

Bayer HealthCare and J&JPRD also claim that you must drastically modify your diet in order to safely take Warfarin.  While it is true that your diet on Warfarin requires some modification, Xarelto greatly exaggerates the extent to which that is necessary.

Vitamin K reacts with Warfarin and changes the way the medicine affects your body. The body uses vitamin K in multiple ways to help with blood clotting. This is why it is necessary to maintain consistent vitamin K levels in your diet while on Warfarin. Too much vitamin K in the diet will prevent Warfarin from effectively treating the condition and could lead to blood clots. A sudden drop in vitamin K levels could make the current dosage too effective and cause uncontrollable bleeding. This is why Warfarin users require monitoring to ensure their dosage is adjusted to the optimal level.

Most of the vitamin K in a person’s diet is found in green leafy vegetables like kale or Brussels sprouts. While Xarelto ads suggest taking Warfarin requires dietary restrictions, many health experts say, instead, that a Warfarin regimen requires dietary constancy. If you like foods with vitamin K, you don’t have to stop eating them while on Warfarin, as Xarelto claims, you only need to maintain a consistent level of vitamin K in your diet each day.

If you like a certain food that contains vitamin K, you need to eat it every day. You will be hard pressed to find a doctor who will tell you that eating a daily dose of vegetables is unhealthy. Your doctor or registered nutritionist will be able to assist you in finding a dietary regimen that keeps you happy and keeps Warfarin effective.

Find out more about the amount of vitamin K different foods contain.

Xarelto Seems More Convenient, Why Would I Not Want to Take it?

In many ways, Xarelto is more convenient than Warfarin for those with very active lifestyles. But convenience should never be a serious factor when determining whether a drug is the ideal choice for you, especially when there are serious questions about its risk to your health.  Managing the blood’s clotting ability is difficult and no blood thinner is risk-free.

The main dangers associated with blood thinners, excessive bleeding or clotting, are caused by overdosing or underdosing, respectively. Warfarin is calibrated for each individual based on his or her physiology, accounting for the patient’s weight, age, sex, and vitamin K levels. Xarelto, on the other hand, has a standard dosage. Warfarin patients must be monitored and their dosage recalibrated to most effectively treat their conditions. Xarelto’s once-a-day standard does not need to be monitored but also does not consider each patient’s specific needs.

A 2014 annual review of drug safety reported that Xarelto, out of all therapeutic drugs, had the highest rate of serious injury reported to the FDA. Serious injury was reported to the FDA at an average of 6.6 reports per 1,000 person-years. The report also indicated that, in that same period, Xarelto had the highest rate of treatment failures out of any blood thinning medication – including Warfarin. Due to the one-size-fits-all approach in regards to dosage, Xarelto fails to prevent blood clots in more patients than any other drug.

High levels of Xarelto can be problematic if the patient needs emergency surgery. In the case of Warfarin, the coagulating reversal agent can be taken or vitamin K administered. If Xarelto is in the blood, doctors must wait to perform surgery until enough of the medication has left the blood stream to allow adequate clotting for surgery. This may delay necessary or emergency medical procedures much longer than would otherwise be advisable by medical professionals.

If a patient’s Xarelto levels are too high and they are at risk for excessive bleeding or require emergency surgery, the only course of action left to doctors is plasma transfusion – another procedure that carries its own risks.  Until a pharmaceutical anticoagulant reversing agent is approved by the FDA, the safety of Xarelto remains uncertain at best.

If you or a loved one are on or have been treated with Xarelto and have experienced side effects such as uncontrollable bleeding, you may be able to receive compensation. Do not stop taking Xarelto without first seeking the advice of your doctor as it may cause conditions to worsen. To learn more about any legal options that may be available to you, just complete our free no- obligation consultation form today.

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