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Approval of Safer Alternative to Pradaxa Delayed by FDA

Dallas, TX (PRWEB) June 26, 2012

The Pradaxa Resource Center, a patient advocacy group, is alerting patients who have suffered internal bleeding after taking the drug Pradaxa that the release of a safer alternative to the drug has been delayed by an FDA decision.

For now, anyone who has suffered internal bleeding after taking Pradaxa is encouraged to speak with their doctor about their options and to a lawyer about their legal rights as soon as possible.

Pradaxa is an anticoagulant medication prescribed to patients with atrial fibrillation in order to prevent strokes. The Wall Street Journal reported on April 24, 2012, that the drug already reached the $1 billion blockbuster sales mark for the 12-month period ending in February.

Unfortunately, several reports have identified risks with the drug. The FDA warned on December 7, 2011 that it was looking into the safety of Pradaxa after receiving higher than expected reports of injury or death. Most recently, the Institute for Safe Medication Practices reported on June 6, 2012 that Pradaxa led all other medications in 2011 for number of death and bleeding reports to the FDA.

Now, Reuters has reported on June 25th that the FDA is delaying the approval of Eliquis, a rival anticoagulant to Pradaxa developed by Bristol-Myers Squibb Co and Pfizer Inc. According to the article, the new drug will be marketed as a safer alternative to Warfarin since many cardiologists are no longer comfortable prescribing Pradaxa.

Due to the number of people affected by Pradaxa internal bleeding, lawyers have asked that the large number of expected lawsuits be consolidated into one central federal court. The Pradaxa lawsuit is known as Case MDL No. 2385 IN RE: Pradaxa Product Liability Litigation, Southern District of Illinois.

The Pradaxa Resource Center believes that the consolidation of Pradaxa lawsuits into one court will expedite the litigation process and help victims share in valuable evidence. However, due to the specialized nature of these federal MDL cases, only certain lawyers can help.

Anyone affected by Pradaxa side effects is urged to speak with a lawyer about their legal options. The Pradaxa Resource center works only with lawyers who are already handling Pradaxa lawsuits.

For more information on the research, warnings, pradaxa side effects and legal options relating to the drug Pradaxa, or to speak with a lawyer, visit

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Source: PRWeb
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