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SOURCE: The Driscoll Firm, P.C.
Serious concerns about Pradaxa’s side effects are underscored by the FDA’s new warning that the blood thinner should not be used to prevent stroke or blood clots in patients with mechanical heart valves, says Driscoll of The Driscoll Firm, P.C.
St. Louis, MO (PRWEB) January 31, 2013
John J. Driscoll, a nationally recognized attorney representing drug injury victims, today urged patients to read the U.S. Food and Drug Administration’s recent warning about the prescription blood thinner, Pradaxa.
In a drug safety communication issued last month, the FDA warned that Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots in patients with mechanical heart valves.
The FDA said it was issuing the warning after a clinical trial in Europe, called the RE-ALIGN trial, had been stopped due to evidence that “Pradaxa users were more likely to experience strokes, heart attacks and blood clots forming on the mechanical heart valves” and had shown “more bleeding after valve surgery” than users of the anticoagulant warfarin.
“This new warning from the FDA underscores ongoing concerns about Pradaxa side effects,” Driscoll said. “Mechanical heart valve patients and other Pradaxa users should review this new information and consider their medical and legal options going forward.”
Driscoll is the founder of The Driscoll Firm, P.C., which provides legal help to drug injury victims and their families across the country. The attorney said his firm is reviewing potential injury claims arising from the use of Pradaxa.
Pradaxa is a prescription blood-thinning medication that the FDA approved for the U.S. market in 2010 for use in reducing the risk of stroke and blood clots in patients with non-valvular atrial fibrillation, a common heart rhythm abnormality. It is manufactured by Boehringer Ingelheim Pharmaceuticals.
In December 2011, the FDA announced that it was conducting a safety review of Pradaxa after receiving “post-marketing reports of serious bleeding events” in patients taking the drug.
In November 2012, the FDA provided an update on the review, saying an assessment done by using insurance claims and administrative data indicated that bleeding rates associated with new use of Pradaxa did not appear to be higher than those associated with new use of warfarin. However, the FDA said, it would continue its “ongoing safety review of this issue.”
To stay on top of the latest legal and medical information about Pradaxa, Driscoll directed concerned patients and family members to his firm’s SettlementHelpers.com website.
About The Driscoll Firm, P.C.
The Driscoll Firm, P.C., is dedicated to fighting for the rights of people and families injured by the wrongful acts of individuals and companies. The firm is currently investigating national injury claims involving product liability, defective drugs, dangerous medical devices, medical malpractice, car accidents, premises liability, spinal cord injuries, birth injuries, Cerebral Palsy, brain injuries, Erb's palsy and other circumstances that have caused serious injury or death. The Driscoll Firm, P.C., is based at 211 N. Broadway, 40th Floor, St. Louis, MO, 63102, and serves clients nationwide. To learn more, call (800) 305-9800 or use the firm’s online contact form. All initial consultations are free and confidential.
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