Patents who suffer from the heart irregularity atrial fibrillation, or who are at risk of blood clots after a major surgery, are often prescribed a blood thinner to reduce the risk of stroke.
Three oral blood thinners released between 2010 and 2012 - Pradaxa, Xarelto and Eliquis - have been fighting it out to gain a share of the estimated $6 billion anticoagulant market from warfarin, a drug used since the 1950s.
Consumers have been bombarded with television ads promising the drugs are as safe or safer than warfarin, without the need for regular blood tests or changes in diet.
And now, with the combined number of prescriptions for these drugs climbing over 11 million per year, the Institute for Safe Medication Practices has released a new report comparing the safety profile of each drug based on the number of side effects reported to the FDA.
Safest Among New Blood Thinners: Eliquis
Eliquis was the last of these three medications to gain FDA approval in 2012. And, as a result, it has the fewest number of yearly prescriptions. However, it has consistently produced the fewest number of patient side effects.
Last year, doctors prescribed Eliquis 2,179,340 times. This was slightly less than Pradaxa and less than a third of Xarelto prescriptions. However, in a review of adverse event reports received by the FDA, Eliquis had only 1,014 reports of serious injury.
In terms used by experts, this amounted to only 4.4 reports for every 1,000 patient year prescriptions. Approximately half of all serious side effects involved internal bleeding, and around 10% of these resulted in death.
Xarelto Tops in Sales, Second in Safety
Xarelto, the only one of the three to allow once-per-day dosage, was released in 2011 and quickly surpassed Pradaxa as the most prescribed of the three new anticoagulants. It now is prescribed more than 6.7 million times each year in the United States, more than Eliquis and Pradaxa combined.
And while one would expect much higher reports of side effects due to its massive market share, Xarelto actually ranks second in the average number of incidences.
Last year, the FDA received 3,331 adverse event reports indicating a serious side effect from Xarelto. That amounted to 6.6 serious complications for every 1,000 patient years. Like Eliquis, nearly half of these involved serious internal bleeding and 11.4% resulted in death.
Side Effect Reports Substantially Higher for Pradaxa
Pradaxa is currently second in total prescriptions in the United States with 2,257,507 in 2014, but ranks last in safety according to the ISMP Quarterwatch report. With 3,592 total reports of serious side effects to the FDA, it averaged 14.1 for every 1,000 patient years.
Approximately 75% of these reports involved internal bleeding events, the largest percentage by far among the three. Also highest was that 20.9% of serious Pradaxa side effects resulted in death, according to the FDA numbers.
One bright spot for Pradaxa is the fact that its manufacturer, Boehringer Ingelheim, is the first to get FDA approval this year for an antidote that can stop internal bleeding in emergencies. The makers of both Xarelto and Eliquis hope to offer similar antidotes soon, but they are still in clinical trials.
The institute found a few reasons for the high number of side effects involved with these drugs. For example, Xarelto promises effectiveness with only one pill per day. However, during the course of a 24-hour day, the concentrated peak of the drug could be nearly 17 times higher than when its effect run out.
Due to problems with patients metabolizing Pradaxa, around 17% of people would actually get a lower dose than needed, which could raise the risk of stroke. Almost half of patients, on the other hand, would get more Pradaxa than they need, resulting in greater risks of internal bleeding.
So far, more than 6,000 patients and their families have filed lawsuits against Pradaxa or Xarelto for hospitalization or death caused by internal bleeding. The maker of Pradaxa has already paid out more than $650 million in compensation and new trials are expected next year for Xarelto lawsuits.
Based on the above study by the Institute for Safe Medication Practices, DrugNews recommends any patient currently taking either of these three drugs speak with their doctor about the safest alternative.
Those who’ve suffered internal bleeding while on Xarelto or Pradaxa should also talk with a lawyer about their legal rights to compensation. DrugNews can connect you with a lawyer today.
ISMP QuarterWatch 2014 Annual Report. Contrast in Novel Anticoagulants’ Safety Profiles. (September 23, 2015). Retrieved from www.ismp.org
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