Two Studies Point to Pradaxa Heart Attack Risk

The controversial anticoagulant Pradaxa has been linked to an increased risk of heart attack in two new studies. News of a Pradaxa heart attack risk comes in the wake of a string of high-profile court cases alleging serious – sometimes fatal – internal bleeding events caused by the drug, which is manufactured by Boehringer Ingelheim. The conclusions of the two independent studies have caused particular alarm, as Pradaxa is designed partly to reduce the risk of heart attacks.

One of the studies, presented at the 2013 Congress of the International Society on Thrombosis and Haemostasis, indicated that Pradaxa side effects may increase the risk of heart attack by as much as 70% when compared to a placebo group.

The other study was published recently in the Journal of the American College of Cardiology. Researchers compared data from the safety profiles of Pradaxa and warfarin, an older anticoagulant. The authors alleged that Pradaxa could increase the risk of heart attack by 48%.

The observational study analyzed data from the Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY) and data given to the FDA by Boehringer Ingelheim. Researchers concluded that even when the RE-LY figures were disregarded, there was still a statistically significant Pradaxa heart attack risk.

The findings presented in the Netherlands came from randomized controlled trials (RCTs) conducted by Belgian researchers. Out of 23,839 patients treated with Pradaxa, 292 suffered heart attacks. The risk was shown to increase with higher dosages, indicating a causal link between Pradaxa and heart attacks. The researchers stated that “health care professionals and regulators should consider appropriate strategies to prevent such serious adverse drug reactions.”

Pradaxa heart attack risk not disclosed by drug maker

Pradaxa was developed primarily to treat patients at risk of a stroke. Central to Boehringer Ingelheim’s marketing campaign was the claim that Pradaxa was a safer alternative to warfarin, which has been used with great success for more than five decades. Introduced in 2010, it was promoted as a safer, more convenient alternative to warfarin.

The drug maker pointed to the close monitoring required for warfarin patients, something they claimed was not necessary with Pradaxa. But unlike warfarin, Pradaxa has no reversal agent to treat bleeding problems, and doctors are helpless in the face of hemorrhaging.

Pradaxa side effects cited in thousands of FDA reports

Between October 2010 and March 2011, more than 272,000 prescriptions for Pradaxa were issued in the U.S. During the same period, 932 ‘Serious Adverse Event’ (SAE) Medwatch reports were filed with the FDA.

Between April and June 2011, a further 856 SAE reports were filed, including 117 deaths, and 510 reports of severe, life-threatening internal Pradaxa bleeding events.

A review conducted by The Institute for Safe Medication Practices (ISMP) showed Pradaxa generated 956 adverse event reports in 2012, including 178 fatalities. According to the ISMP, the death rate associated with Pradaxa side effects is five times higher than with warfarin.

Hundreds of lawsuits alleging Pradaxa bleeding are pending against Boehringer Ingelheim, many of which have been consolidated into multidistrict litigation (MDL), which is currently in the discovery process.