Waxahachie, TX (Law Firm Newswire) December 24, 2014 - A new study has found that the blood thinner Pradaxa carries a significantly higher risk of major internal bleeding than warfarin, a traditional medication that has been used for decades to help prevent blood clots.
According to reports in HealthDay News and Harvard Health, this is major news because until now, doctors prescribing Pradaxa have been told that it offers a lower internal bleeding risk than warfarin.
Many doctors and patients are alarmed, as new data show that the risks are much higher than were claimed when the drug was initially approved by the Food and Drug Administration (FDA).
John Hale, an attorney who frequently handles dangerous drug cases, explained that FDA approval does not guarantee drug safety. “Ultimately, drug manufacturers are responsible. They must conduct as much testing as is necessary to ensure that a drug is reasonably safe. But with Pradaxa, it seems as though the manufacturer, Boehringer Ingelheim, simply met the FDA’s minimum requirements and stopped there.”
Pradaxa was cleared by the FDA under a fast-track approval process that requires less clinical testing. The New York Times reports that Pradaxa was cleared by the FDA on the basis of a single clinical trial.
Hale asserts that as more facts emerge about Pradaxa, it becomes increasingly likely that plaintiffs will be successful in claiming that the manufacturer was negligent in not conducting more trials.
Fierce Pharma, an industry watchdog, claims that more than 2,000 Pradaxa lawsuits have been filed by patients nationwide.
Both the manufacturer and doctors strongly urge patients not to stop taking Pradaxa without close medical supervision. Any concerned individual should talk to a doctor before changing or stopping their use of Pradaxa.
The Hale Law Firm
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Waxahachie, TX 75165
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