While the relatively new blood-thinner Pradaxa has been hailed as the next generation of anti-coagulants, in 2011 the Institute of Safe Medication Practices reported that the popular medication was linked to more deaths and injuries than any of the 800-plus other drugs it reviewed.

Anticoagulant drugs like Pradaxa are a high-risk treatment and cause bleeding in approximately 15 percent of patients with atrial fibrillation when exposed to the drug for a year, according to a May 2014 issue of Quarter Watch, a publication that monitors FDA MedWatch reports.

Recent data showed a new trend in the numerous serious adverse event reports associated with dabigatran (Pradaxa) and rivaroxaban (Xarelto), two of the newer anticoagulants on the market. A third blood-thinner — Eliquis (apixaban) — has also received FDA approval.

Xarelto outpaced Pradaxa adverse reports, though Pradaxa has previously been the main focus of safety concerns reported by QuarterWatch and elsewhere. The uptick is believed to be explained by a change in the number of patients exposed to the two drugs.

Total dispensed outpatient prescriptions for Xarelto rapidly increased to nearly one million prescriptions per quarter, while Pradaxa use has steadily declined since a peak in early 2012. By the end of 2013, according to QuarterWatch, Xarelto prescriptions outnumbered dabigatran by almost two-to-one.

Pradaxa received FDA approval in 2010. The following year physicians’ groups and patient advocates voiced concern over 3,781 adverse effects and 542 deaths reported to the FDA. In 2012, Pradaxa sales had eclipsed $1 billion.

Pradaxa bleeding lawsuits began rolling in. Plaintiffs filed more than 4,000 Pradaxa bleeding lawsuits. Boehringer Ingelheim agreed to pay $650 million in a comprehensive settlement.

“It’s a drug of questionable efficacy, and the real fraud has been perpetuated on the patients,” a plaintiff’s attorney told USA Today. “They developed a take-and-forget-it, one-size-fits-all drug, which injured an extreme amount of people.”

Unlike warfarin (Coumadin), which was the sole anticoagulant on the market until recent years, there is no Pradaxa reversal agent to reverse a bleeding episode, though drug maker Boehringer Ingelheim is reportedly close to finding an antidote and is trying to expedite FDA approval.

Warfarin bleeds can be reversed by administering an antidote derived from vitamin K.

QuarterWatch reported that new data has shown that the drug’s bleeding risks could be substantially reduced if two therapeutic options available in most advanced countries were approved in the United States.

Those options include a lower, twice daily dose and a lab test capable of identifying patients who need a dose adjustment “because the effect on thrombin inhibition is either excessive, increasing the risk of severe bleeding, or sub-therapeutic, exposing the patient to a higher risk of stroke or other blood-clot related adverse event.”

Pradaxa works by reducing the body’s ability to form clots and greatly mitigates the chances of a stroke. But it also keeps the body from being able to stop bleeding — typically done by forming a clot — after an injury. Hemorrhaging can occur in those who take Pradaxa.