Was Pradaxa Approval Rushed By the FDA, Resulting in Unnecessary Bleeding Deaths?
By Andrea Gressman
Safety concerns among medical experts arose with the alleged rushed approval of the anticoagulant drug known as Pradaxa, which the Food and Drug Administration is held liable for. An article written in the Journal of the American Medical Association may be used against the FDA should Pradaxa lawsuits arise from internal bleeding injuries resulting from use of Pradaxa.
Pradaxa does have potentially life-threatening side effects; however, the FDA still approved it, risking the potential to be called out for negligence for approving Pradaxa before it was adequately tested. Thomas J. Moore and Curt D. Furberg indicated that the aforementioned examples raise the question of whether the FDA showed good judgment in their decision to approve three innovative new drugs without first addressing significant safety concerns.
Are Patients Willing to Accept Risks and Side Effects of Pradaxa?
Janet Woodcock, the FDA’s director for the Pradaxa evaluation and review, fought back. She not only defended the agency’s approval process, she also claimed that patients with serious medical issues would prefer to have as many medical options available to them, even if there are risks and side effects involved.
She stressed that due to the amount of unmet medical needs, patients are willing to take greater risks. In 2011, 16 of the 35 medications that the Food and Drug Administration approved were given “Priority Reviews,” which is a short-cut review process for medications that offer a therapeutic advance. As a result of the rushed review process, which may not address important safety concerns, many of these drugs do contain dangerous, potentially life-threatening side effects.
Pradaxa is designed to prevent blood clots as it acts as a blood-thinner. It also prevents subsequent complications in patients with non-valvular atrial fibrillation. Pradaxa, approved in 2010, was intended to replace the anticoagulant warfarin, because of the reduced level of medical and dietary monitoring on the patient’s part. Vitamin K has been proven to stop internal bleeding caused by warfarin; however, Pradaxa internal bleeding cannot be stopped, which makes it an extremely dangerous side effect of Pradaxa.
A Number of Pradaxa Lawsuits Filed Across the Country
Pradaxa internal bleeding injuries have caused quite a flurry of Pradaxa lawsuits from around the country, as many are seeking compensation in the loss of loved ones due to lethal Pradaxa side effects. Over 500 patients have lost their lives due to Pradaxa internal bleeding and Pradaxa hemorrhaging. As a result of these numbers, it does not seem that the amount of Pradaxa lawsuits being filed will slow down anytime soon.
If some you love has experienced Pradaxa internal bleeding, Pradaxa hemorrhaging or other Pradaxa side effects, it is important that you speak with a Pradaxa lawsuit attorney right away. The number of Pradaxa lawsuits is growing rapidly and the court proceedings are going to move along quickly in order to handle the number of Pradaxa lawsuits in a thorough manner. Please visit the Pradaxa Internal Bleeding Class Action Lawsuit Investigation page in order to receive your free legal consultation right away. You may have a case to seek compensation through a Pradaxa lawsuit settlement or Pradaxa class action lawsuit settlement.
Updated September 24th, 2012
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