Motley Rice lawyers are reviewing potential Pradaxa lawsuits involving patients who took the blood-thinning drug Pradaxa® and experienced serious or fatal bleeding.
Manufactured by Boehringer Ingelheim , Pradaxa is an anticoagulant, or blood thinner, medication prescribed to help prevent stroke by preventing the formation of blood clots. The FDA is investigating the safety of Pradaxa following reports that the drug may lead to excessive bleeding that could result in severe and even life-threatening injury.
Contact a Pradaxa Lawyer
If you or someone you know has experienced Pradaxa side effects such as serious or fatal bleeding, and are in interested in speaking with an attorney about a possible Pradaxa lawsuit, please contact medical drug lawyer Carmen Scott by email or by calling 1.800.768.4026 .
Pradaxa Side Effects
Pradaxa has been linked to excessive bleeding that can be serious or fatal. Signs or symptoms of serious bleeding can include:
- bleeding that is severe or uncontrollable
- bruises that happen without a known cause or that get larger
- coughing up blood or blood clots
- menstrual or vaginal bleeding that is heavier than normal
- nose bleeding that happens often
- pink or brown urine
- red or black stools (looks like tar)
- unusual bleeding from the gums
- vomiting blood or vomit that looks like coffee grounds
Pradaxa is an oral drug generically known as dabigatran etexilate mesylate that is prescribed to reduce the risk of blood clots and stroke in patients with non-valvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.
The FDA issued a safety announcement in December 2011 stating that it planned to evaluate post-market reports of serious bleeding associated with Pradaxa following a November 2011 warning issued by the European Medicines Agency (EMA). The EMA reported more than 250 cases of serious and even fatal bleeding complications associated with Pradaxa.
The FDA communication states that potential serious or even fatal bleeding is a known complication of all blood-thinning drugs, but the organization is working with Boehringer Ingelheim to review the post-market reports of excessive bleeding to determine whether they are higher than should be expected based on results from the clinical trial that supported the drug's 2010 approval.
The FDA also advises that "Patients with AF should not stop taking Pradaxa without talking to their healthcare professional. Stopping use of blood thinning medications can increase their risk of stroke. Strokes can lead to permanent disability and death."
Read the FDA Pradaxa Safety Announcement.
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