Pradaxa

Dabigatran Shouldn’t Be Used in Patients with Mechanical Heart Valves .

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Dabigatran (Pradaxa) should not be prescribed to prevent blood clots or stroke in patients with mechanical heart valves, the FDA warned.

The warning follows the termination of a European clinical trial in which patients taking dabigatran had more frequent thromboembolic events than those on warfarin. Dabigatran patients also experienced more bleeding after valve surgery.

Patients with mechanical heart valves should be transitioned from dabigatran to another anticoagulant, the FDA recommends; stopping dabigatran use suddenly can increase blood clot and stroke risk.

Source: FDA MedWatch safety alert

 

Pradaxa Does Not Pose Higher Risk for Serious Bleeding .

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New patients taking dabigatran (Pradaxa) don’t have higher rates of bleeding than those on warfarin, according to the results of an FDA investigation. Despite that reassurance, patients may ask about a story in the New York Times about the bleeding risks associated with the drug.

The findings of the agency’s safety evaluation are consistent with those from the clinical trial used to approve the drug, says the FDA. However, this may do little to reassure critics who point out that, unlike warfarin, there is no way to reverse dabigatran’s anticoagulant effects. The Times reports that the drug has been linked to over 500 deaths in the U.S.

The FDA says it will continue evaluating “multiple sources of data” as part of an ongoing safety review. In the meantime, dosing recommendations should be carefully followed to reduce the risk for bleeding, especially in patients with renal impairment.

Source: FDA MedWatch safety alert

Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication – Safety Review of Post-Market Reports of Serious Bleeding Events

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FDA is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. The Pradaxa drug label contains a warning about significant and sometimes fatal bleeds. In a large clinical trial (18,000 patients) comparing Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs.

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.

BACKGROUND: Pradaxa is a blood thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.

RECOMMENDATION: At this time, FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label.

Patients with AF should not stop taking Pradaxa without talking to their healthcare professional. Stopping use of blood thinning medications can increase thfdaeir risk of stroke. Strokes can lead to permanent disability and death.

source:FDA