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No Official Pradaxa Recall - FDA Warnings

pradaxa recall infoThe blood thinning drug Pradaxa has been widely prescribed since it was released in 2010, achieving the designation of a blockbuster drug with more than $1 billion in sales and use in more than 70 countries. However, recent reports indicate Pradaxa may have serious health risks.

The FDA, Health Canada, Institute for Safe Medicine Practices, AMA and Journal of Neurosurgery have all warned that Pradaxa may cause uncontrollable internal bleeding. Unfortunately, the FDA has yet to issue a Pradaxa Recall.

In December, 2011 the FDA announced it was launching an investigation into the safety of Pradaxa after receiving more injury or death reports than expected. USA Today reported that the FDA received 3,781 side effect reports and 542 death reports among users in 2011, more than all other medications.

Although the FDA has not issued a Pradaxa Recall, a federal judge recently ruled that those injured by internal bleeding after taking the drug may proceed with lawsuits.

If you suffered internal bleeding while taking Pradaxa or have a loved one who was affected, it is important to learn your legal rights to file a claim. Contact us today to speak with a lawyer.

In September of 2012, The Journal for The American Medical Association prompted new calls for a Pradaxa recall when it warned that the FDA may have rushed approval of the drug, overlooking key side effects like internal bleeding.

A study from the University of Pécs in Hungary released that same month suggested the risks of Pradaxa may outweigh the benefits. Researchers there found that patients taking the drug after an acute coronary syndrome were three times as likely to have a bleeding event.

While all blood thinner medications can cause internal bleeding, bleeding from other drugs like Coumadin can be treated with reversal agents. In the March, 2012 issue of Journal of Neurosurgery, researchers discussed concerns by doctors over Pradaxa internal bleeding - once the drug causes it, there is little they can do to stop it.

Experts fear thousands of patients may ultimately suffer serious internal bleeding or death due to the failure of regulators to issue a Pradaxa recall. For now, the only recourse for those affected is legal action. Since so many Pradaxa lawsuits are expected, they have been consolidated to a special federal court in Illinois.

Lawyers are currently helping those affected by Pradaxa bleeding file claims against the manufacturer. If you or a loved one were injured, it is important to learn your legal options and how long you have to take action.

Before you choose a lawyer, make sure they are qualified for this type of lawsuit and have experience fighting large drug companies. The Drug Resource Center only recommends law firms that specialize in Pradaxa lawsuits.

For more information on the side effects, warnings and legal action related to the drug Pradaxa, or to speak with a lawyer, contact us today. We are available 24 hours a day to provide help.

Authored by Chris Schroeder