FDA is working to determine whether the reports of bleeding in patients taking Pradaxa® are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa®.
(PRWEB) January 25, 2012
Flood Law Group, LLP, a litigation firm, is announcing the launch of the new website, PradaxaInjury.com, designed to assist individuals in learning about the possible risks associated with the anticoagulant medication Pradaxa®.
According to Flood Law Group, LLP, people who are treated with Pradaxa® (dabigatran etexilate) and who suffer internal bleeding, heart attack and/or other serious complications, may be eligible to seek compensation by filing a Pradaxa® injury lawsuit.
Pradaxa® is prescribed to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), a common type of heart rhythm problem.
While all anticoagulants increase the risk of internal bleeding, the U.S. Food and Drug Administration (FDA) issued a safety communication on Dec. 7, 2011, saying that it is evaluating post-marketing reports of severe bleeding events in people taking Pradaxa®.
“FDA is working to determine whether the reports of bleeding in patients taking Pradaxa® are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa®,” the FDA said in the safety communication.
Patients taking Pradaxa® should be aware of the symptoms of internal bleeding, which include:
- Frequent nosebleeds
- Unexplained bleeding from the gums
- Coughing up blood
- Throw up that looks like coffee grounds
- Pink or brown colored urine
- Dark (tar-like) stools
In addition to life-threatening bleeding events, Pradaxa® has also been linked to an increase in the risk of heart attack and severe symptoms of heart disease.
About Flood Law Group, LLP
Flood Law Group, LLP helps patients and families that are affected by Pradaxa® injuries seek compensation for their injuries. PradaxaInjury.com is an online resource that aims to provide patients and families with useful information and resources.
For more information about the possible side effects of Pradaxa® or to schedule a free review of your case, please call 1-888-365-8938.