In October 2010, the FDA approved the new blood thinning drug called “Pradaxa” for use in patients with atrial fibrillation (AFib). According to the clinical studies conducted prior to approval, Pradaxa (dabigatran etexilate) reduced the risk of stroke due to AFib by 35 percent more than warfarin, the standard treatment. In addition, since Pradaxa works differently than warfarin, patients do not have to undego regular blood tests or worry about dietary restrictions.
Only a few short months after the approval, however, the FDA started receiving reports of serious Pradaxa side effects, including uncontrollable Pradaxa bleeding and life-threatening cerebral hemorrhages. In December 2011, the agency released a drug safety communication stating that they were investigating the safety of the drug, and in 2012, patients began filing new Pradaxa stroke lawsuits.
As awareness increases about Pradaxa side effects, critics say that manufacturer Boehringer Ingelheim may not have provided adequate warnings to the public and physicians, and may have failed to conduct adequate safety studies before releasing the drug onto the market.
When to File a Pradaxa Stroke Lawsuit
Patients who took Pradaxa and then experienced serious Pradaxa side effects like uncontrollable bleeding may be eligible to file a Pradaxa stroke lawsuit. It wasn’t until January 2012, for instance, that Boehringer Ingelheim added verbiage to the warning label alerting patients and physicians to the fact that such side effects cannot be reversed with vitamin K.
Patients who take warfarin and suffer a fall, for example, may experience bleeding, but such bleeding can be stopped by the administration of vitamin K. Currently, doctors have no comparable quick antidote to Pradaxa bleeding, as vitamin K doesn’t work.
In addition, the FDA is reviewing post-marketing reports of Pradaxa side effects to determine whether they may be occurring more than was expected. If they find out they are, they may release further safety information that would support a Pradaxa stroke lawsuit.
A Pradaxa Lawyer is Aware of the Reports
A Pradaxa lawyer is aware of all the controversy currently surrounding this drug, including the over 250 deaths linked with the blood thinner, and the fact that over 300 adverse events were reported to the FDA in the first three months the product was on the market. A Pradaxa lawyer is also aware that critics claim the original clinical trials used to gain FDA approval were flawed, biased, and misleading, and that other countries like New Zealand are conducting their own investigations of the drug’s safety profile.
Finally, a Pradaxa lawyer is aware that new reports of hemorrhagic strokes”caused by bleeding in the brain”have been linked to the drug, with some patients filing a Pradaxa stroke lawsuit against Boehringer.
A Pradaxa Lawyer Can Help
If you or a loved one has suffered serious Pradaxa side effects, you may be eligible for a Pradaxa stroke lawsuit. Contact a Pradaxa lawyer at Chaffin Luhana LLP today for a confidential case evaluation at 1-888-480-1123.