Pharmaceutical Dangers: The Story of Pradaxa

More than 2 million people take blood thinners every year, making this segment of the pharmaceutical market a multibillion-dollar industry and spurring on drugmakers to develop and sell competitive new drugs that bring in profits. Unfortunately, sometimes even after studies show dangerous side effects, a hazardous drug will remain on the market. And it is the consumer who pays the price.

That is the case with Pradaxa, a newer blood thinner that can have debilitating side effects like bleeding accidents, which can be fatal.

A New Blood Thinner 

Blood thinners are used to decrease the risk of heart attack and stroke; help patients following knee or hip replacement surgeries; and treat atrial fibrillation (irregular heartbeat).
For decades, there was only one blood thinner on the market: warfarin.
Pradaxa arrived in 2010, and it has since been used by millions of Americans. With Pradaxa, Boehringer Ingelheim offers patients a blood thinner that is more convenient than warfarin. Pradaxa does not require the diet changes or regular blood tests that warfarin does, and in clinical trials it performed with an equal level of safety and efficacy.
However, Pradaxa has been linked to thousands of adverse events — including severe bleeding events — prompting further evaluation by the Food and Drug Administration (FDA).

Pradaxa Timeline

Oct. 19, 2010: FDA approves Pradaxa for the prevention of stroke and blood clots in patients with atrial fibrillation.
Dec. 7, 2011: FDA reports hundreds of reports of serious bleeding events related to Pradaxa.
March 2012: Two journals publish studies revealing that Pradaxa has a greater risk of heart problems, including heart attacks, than warfarin.
May 31, 2012: QuarterWatch, a publication for the Institute of Safe Medication Practices, issues a report stating that Pradaxa accounted for 3,781 serious adverse events in 2011, including 542 deaths.
August 2012: Federal Pradaxa lawsuits against Boehringer Ingelheim are consolidated into multidistrict litigation in the U.S. District Court for the Southern District of Illinois.
Nov. 2, 2012: The FDA reviews data on serious bleeding events and claims that Pradaxa does not present a greater risk of serious bleeding than warfarin.
Dec. 19, 2012: The FDA informs the public that Pradaxa is not indicated for use in patients with atrial fibrillation caused by mechanical heart valves.

The Future of Pradaxa

Even with Pradaxa’s history of debilitating side effects and litigation, the drug remains on the market. Patients need to be aware of the risks of Pradaxa – specifically, the risk of uncontrollable bleeding. Unlike warfarin, there is no antidote for bleeding caused by Pradaxa. Patients and doctors need to decide whether the benefits of Pradaxa outweigh the risks.
Boehringer Ingelheim is seeking approval from the FDA to expand the use of Pradaxa for patients who have had hip or knee replacement surgery. Any expanded use of Pradaxa could put more patients at risk.

 Alanna Ritchie is a researcher and writer for Drugwatch.com, a consumer advocacy website.
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