Pradaxa linked to unexpectedly high number of fatal bleeding incidents

At the end of last year, the FDA caught the attention of thousands of patients when it issued new drug safety information concerning the link between Pradaxa and potentially deadly hemorrhaging. Pradaxa is a blood thinning medication that helps to reduce the risk of stroke for patients who suffer from a heart condition known as non-valvular atrial fibrillation. The drug was approved for use by the FDA in 2010, providing a substitute for the widely-used, but risky drug warfarin. But since then, a number of hemorrhaging incidents have called into question the safety of Pradaxa.

Atrial fibrillation (AF) is the most common type of persistent irregular heartbeat. Patients who suffer from this particular condition face a greatly increased risk of stroke. When the heart doesn’t beat strongly and regularly, there is a greater likelihood that a blood clot can develop and travel to the brain, which in turn results in a stroke. Often, patients with AF use medications like Pradaxa or warfarin to counter this risk. The anticoagulant drugs act as blood thinners to prevent clots from forming. Between obtaining FDA approval in October of 2010 and August of 2011, nearly 1.1 million Pradaxa prescriptions were filled in the United States.

But the use of blood thinners like Pradaxa carries its own risk: even a minor scrape or injury can quickly result in excessive and uncontrolled hemorrhaging. This was apparently known at the time of FDA approval, and studies even showed bleeding events occurred at the same rate for Pradaxa as compared to warfarin. But after Pradaxa went on the market, there has been higher rate of reported bleeding incidents than expected. The FDA continues to investigate why that is the case.

In the meantime, claims against the maker of the anticoagulant drug Pradaxa are starting to make their way into the court system. This last month, three plaintiffs filed suit in the United States against the German company that makes the drug, Boehringer Ingelheim. That company admits that in just one year of being on the market, Pradaxa was linked to 260 cases of fatal bleeding.

While the FDA investigation and litigation moves forward, patients are advised not to stop taking the drug without consulting their physician. But at the same time, patients need to be keenly aware of any adverse effects that indicate a bleeding problem:

• unusual bleeding from the gums
• nose bleeding that happens often
• menstrual or vaginal bleeding that is heavier than normal
• bleeding that is severe or you cannot control
• pink or brown urine
• red or black stools (looks like tar)
• bruises that happen without a known cause or that get larger
• coughing up blood or blood clots
• vomiting blood or vomit that looks like coffee grounds.