Pradaxa Lawsuit News: New ISMP QuarterWatch Analysis Shows Pradaxa Adverse Event Reports Led Every Other Medication Monitored By The FDA In 2012
Columbus, OH (PRWEB) October 28, 2013
Reports of Pradaxa bleeding side effects continue to mount, according to the Pradaxa lawsuit lawyers at Wright & Schulte LLC. As per the Institute for Safe Medicine Practices’ most recent QuarterWatch publication, the U.S. Food & Drug Administration (FDA) received 3,292 reports of Pradaxa side effects in 2012, more than any other drug it monitors. Most of the reports involved cases of Pradaxa bleeding, and more than 582 detailed fatalities among Pradaxa users.
According to Wright & Schulte LLC, the bleeding events reported by the ISMP echo allegations made in more than 1,600 Pradaxa lawsuits currently pending in a multidistrict litigation underway in U.S. District Court, Southern District of Illinois. According to court documents, Boehringer Ingelheim is charged with failing to provide adequate warnings about the drug’s alleged dangers, especially the lack of an antidote for Pradaxa bleeding. The first trials in the Pradaxa litigation will get underway in August 2014. (IN RE: Pradaxa Product Liability Litigation, U.S. District Court, Southern District of Illinois, MDL No. 2385)
Wright & Schulte LLC is currently representing plaintiffs in Pradaxa lawsuits, and continues to offer free legal consultations to alleged victims of Pradaxa side effects, including:
- Serious internal bleeding
- Intercranial brain bleeding
- Stomach and intestinal bleeding
- Kidneys and other organs bleeding
- Irreversible life threatening bleeding events
- Heart attack
- Severe allergic reaction
For more information on filing a Pradaxa lawsuit, or to arrange for a free legal consultation, please visit yourlegalhelp.com.
As the ISMP’s QuarterWatch report points out, the FDA continues to maintain that Pradaxa is as safe as warfarin, a blood thinner that has been used for decades. But while either drug can cause episodes of serious internal bleeding, the administration of vitamin K can quickly bring warfarin bleeding to an end. According to the ISMP, warfarin was only named in 861 FDA adverse event reports in 2012, with 56 deaths. While 18% of Pradaxa adverse events resulted in a death, only 6.5% of warfarin events were fatal.
The ISMP was sharply critical of the FDA’s stance on Pradaxa: “The agency took several additional actions to reassure doctors and patients that growing number of adverse event reports did not signal an important risk,” the group states. “The FDA’s many actions to discount mounting safety concerns about anticoagulant adverse effects remain unexplained.”
Wright & Schulte LLC, which is already representing plaintiffs in Pradaxa lawsuits, shares many of the concerns raised by the ISMP analysis. The firm’s Pradaxa lawyers agree with the steps the ISMP outlined to improve Pradaxa safety, including:
- Reassessment of the current one-dose-fits-all strategy to prevent overdoses in vulnerable, older patients.
- More intensive monitoring of kidney function.
- Better information to alert physicians about managing the risks associated with a blood thinner that lacks an emergency antidote for serious bleeding.
Wright & Schulte LLC continues to offer free legal consultations to alleged victims of Pradaxa bleeding side effects. For more information on filing a Pradaxa bleeding lawsuit, or to arrange for a free legal consultation, please visit yourlegalhelp.com.
About Wright & Schulte LLC
Wright & Schulte LLC, an experienced personal injury firm, is dedicated to the belief that America’s legal system should work for the people. Every day, the attorneys of Wright & Schulte LLC stand up for the rights of people who have been injured or wronged and fight tirelessly to ensure that even the world’s most powerful corporations take responsibility for their actions. If you’re looking for a law firm that will guarantee the aggressive and personal representation you deserve, please do not hesitate to contact Wright & Schulte LLC today. Free Pradaxa lawsuit case evaluations are available through yourlegalhelp.com or by calling 1-800-399-0795.