The stroke/blood thinner medication Pradaxa appears on a new adverse event report from the Food and Drug Administration (FDA) due to serious bleeding events associated with it.
According to the FDA, Pradaxa was identified by the Adverse Event Reporting System (AERS) between last July and October due to serious bleeding events, including one hemorrhage with a fatal outcome, that have been linked to the medication.
The FDA previously announced it would be evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa. The medication’s packaging already contains a warning about the risk of significant and sometimes fatal bleeding that can occur in patients. A large clinical trial of 18,000 patients found that bleeding events occur at similar rates in patients who take Pradaxa and warfarin, an older blood-thinning medication.
Pradaxa’s appearance on the AERS follows a FDA safety alert released regarding the medication. Regarding Pradaxa, the FDA stated that it is “continuing to evaluate this issue to determine the need for any regulatory action.”
If you or a loved one have suffered a medical issue caused by Pradaxa usage, contact Sokolove Law today to learn more about potentially pursuing a dangerous drug lawsuit.
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