Pradaxa Side Effects

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Pradaxa is a blood thinning medication used to reduce the risk of stroke. Patients with non-valvular atrial fibrillation (AF) take this anticoagulant. The FDA is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Bleeding is a recognized side effect of anticoagulant therapy. Pradaxa’s drug label contains a warning about significant and sometimes fatal bleeding.

However, the FDA is evaluating whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected. Initially, a large clinical trial of 18,000 patients comparing Pradaxa to warfarin indicated major bleeding events occurred at similar rates for both drugs. Warfarin is an anticoagulant alternative to Pradaxa. This large clinical trial supported the approval of Pradaxa.

The FDA is revisiting bleeding associated with Pradaxa because there have been post-marketing reports submitted to the Adverse Events Reporting System (AERS) database. Serious even fatal bleeding events have been reported. The key issue to the FDA is analyzing whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected. The drug’s manufacturer, Boehringer Ingelheim, is working with the FDA to analyze the reports.

The FDA at this time does make it clear that there is an important health benefit of the drug Pradaxa. Patients should not stop taking Pradaxa without the advice from their doctor or health professional. If you currently take Pradaxa be aware of these symptoms:

unusual bleeding from the gums
nose bleeding that happens often
menstrual or vaginal bleeding that is heavier than normal
bleeding that is severe or you cannot control
pink or brown urine
red or black stools (looks like tar)
bruises that happen without a known cause or that get larger
coughing up blood or blood clots
vomiting blood or vomit that looks like coffee grounds

If you experience any of these symptoms, please seek medical attention immediately. If you believe you have been injured by a drug, please call Longo Legal, PLLC toll free at (855) 566-4648 to find out your rights.

Source:
FDA Drug Safety Communication: Safety review of post-market reports of serious bleeding events with the anticoagulantPradaxa (dabigatran etexilate mesylate); Safety Announcement; 12-7-2011

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