Pradaxa could be the next blockbuster civil settlement
Charles Jackson had been taking the new blood thinner Pradaxa, prescribed by his doctor to prevent strokes, for just three weeks when his intestines began to bleed. His doctor immediately ordered him off the medication. Months later, he learned that Pradaxa was linked dangerous and sometimes fatal internal bleeds. Jackson is now one of hundreds of other patients in a lawsuit waging war against the makers of the drug.
Pradaxa, made by Boehringer Ingelheim, was approved by the Food and Drug Administration (FDA) in 2010 to prevent strokes in patients with a type of heart rhythm abnormality known as atrial fibrillation. It was the first blood thinner approved for atrial patients since warfarin more than 50 years ago.
There was much hope for a warfarin alternative, as the older drug had numerous food and drug interactions and could cause spontaneous bleeding events. As a result, patients on warfarin have to be monitored on a regular basis.
Pradaxa, with fewer interactions, was considered a safer alternative and was approved without the need for monitoring. It soared to blockbuster status. However, adverse event reports began to chip away at the new drug’s star qualities.
A review of Food and Drug Administration (FDA) reports from 2011 showed Pradaxa had been associated with 3,781 adverse effects and 542 deaths. The number of adverse reports and deaths with Pradaxa surpassed all other drugs monitored by the system, prompting the FDA to undergo a safety review of the medication.
With millions of people taking Pradaxa every day, twice a day, the number of adverse events will likely climb. Legal experts say that Pradaxa could be the nation’s next blockbuster civil settlement.
Source: USA Today
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