If you took the blood-thinning drug Pradaxa and then experienced serious Pradaxa side effects like internal bleeding or hemorrhaging, you should consult a Pradaxa lawyer. Recent reports and an FDA warning have raised awareness about a potential link between the Pradaxa and an increased risk of serious, or even fatal, bleeding.
Early Warnings of Pradaxa Side Effects Inadequate?
When the FDA approved Pradaxa in October 2010 to reduce the risk of stroke in patients with atrial fibrillation, the label warned that Pradaxa side effects included a risk of significant and sometimes fatal bleeding. Based on early clinical trials, the risks were considered to be similar to Warfarin, the most popular blood-thinning drug on the market.
In December 2011, the FDA released a drug safety communication stating that it was looking into post-marketing reports of serious bleeding events in patients taking Pradaxa. The FDA is concerned that these Pradaxa side effects may occur more often than originally expected. Those who already experienced injuries from Pradaxa may be eligible for a Pradaxa lawsuit.
Considering a Pradaxa Lawsuit
Within months of Pradaxa’s release, the FDA received over 500 reports of serious Pradaxa side effects related to internal bleeding, hemorrhaging, and other problems. The National Institutes of Health reported nearly 1,000 serious events in 2011 between January and March, including 120 deaths and over 500 hospitalizations. Critics assert that studies used by the manufacturer, Boehringer Ingelheim, were faulty, and incorrectly stated the safety profile of the drug.
Several patients have already stepped forward to file a Pradaxa lawsuit, and many more are expected to follow.
Pradaxa Laywer Likely to Claim Failure to Warn
One of the main concerns with Pradaxa is that if a patient receives an accidental overdose or happens to fall while on the drug, there is no readily available antidote. On the other hand, an overdose of Warfarin, the most common anticoagulant on the market, can be reversed quickly with a dose of vitamin K.
The Pradaxa label said nothing about this problem until January 2012. A Pradaxa lawyer may blame Pradaxa’s manufacturer, Boehringer Ingelheim, for failing to warn of this earlier, as well as for failing to warn of the potentially higher risk of internal bleeding with Pradaxa as compared to Warfarin.
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 a Pradaxa lawyer at Chaffin Luhana LLP today for a confidential case evaluation at 1-888-480-1123.