Patients who took the blood thinning drug Pradaxa (also known as dabigatran) for the treatment of atrial fibrillation or other related heart rhythm problems, and then experienced serious Pradaxa side effects like internal bleeding, hemorrhaging, or even fatal bleeding may be eligible to file a Pradaxa lawsuit. The FDA issued a drug safety communication on December 7, 2011, warning of serious Pradaxa side effects. A Pradaxa lawyer is best suited to advise on the facts of a potential Predaxa lawsuit.
FDA Warns of Pradaxa Side Effects
According to the FDA, reports of serious bleeding raised concern that Pradaxa side effects may occur more often than originally expected. Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all blood-thinning or anticoagulant therapies. The concern is that Pradaxa may cause more of these serious Pradaxa side effects than originally expected when the FDA approved the drug in October, 2010.
The FDA stated that it is working with Pradaxa’s manufacturer, Boehringer Ingelheim, to analyze post-marketing reports for any evidence that might lead to Pradaxa side effects like internal bleeding.
Reports Support Potential Pradaxa Lawsuit
According to the Institute for Safe Medication Practices (ISMP), in the first quarter of 2011, more than 500 reports of fatal, disabling, and other severe hemorrhages were linked with Pradaxa. The ISMP QuarterWatch Report also noted that unlike Warfarin overdoses, which can be reversed with vitamin K, a Pradaxa overdose lacks any readily available counter agent. In fact, a recent report in the Journal of Neurosurgery explained how neurosurgeons were unable to treat an elderly patient who developed a brain hemorrhage after a fall.
In September 2011, reports of serious Pradaxa side effects in New Zealand prompted an investigation after five elderly patients died from internal bleeding. About the same time, Japan asked Boehringer Ingelheim to notify doctors about potentially deadly bleeding in some Pradaxa patients, and suggested that patients over 70 years old may need a lower dose of the drug.
Considering a Pradaxa Lawsuit
After the FDA warning in December 2011, several patients have sought the advice of a Pradaxa lawyer and filed a Pradaxa lawsuit because of serious injuries like internal bleeding. A Pradaxa lawsuit may allege that Boehringer Ingelheim failed to warn patients and doctors that treatment with Pradaxa may be more dangerous than treatment with other anticoagulants, like Warfrain, if the patient falls or has an accidental overdose.
A Pradaxa Lawyer Can Help
If you or a loved one has suffered serious Pradaxa side effects, you may be eligible for a Pradaxa lawsuit. Contact Chaffin Luhana LLP today for a confidential case evaluation at 1-888-480-1123.