Pradaxa Indications Expanded
November 23, 2015 – The U.S. Food and Drug Administration (FDA) approved Pradaxa (dabigatran), a direct thrombin inhibitor, manufactured by Boehringer Ingelheim. Pradaxa was approved to prevent deep venous thrombosis (DVT) and pulmonary embolism (PE) for patients having hip replacement procedures. Dosing for most patients undergoing hip replacement is one 110mg capsule one hour to four hours after surgery on day 1, then patients are to take 220mg (two 110mg capsules) once a day for 28 days to 35 days. Pradaxa has been on the U.S. market for about five years and is already indicated for preventing strokes among patients with non-valvular atrial fibrillation, for treating DVT and PE among patients who have received injected anti-clotting agents for five days to 10 days and for decreasing the risk of additional DVTs or PEs among patients already treated for prior DVTs or PEs. Labeling for Pradaxa includes a boxed warning that stopping the medication too soon may increase the risk of a DVT or PE and the label cautions that patients receiving a spinal procedure, such as spinal anesthesia, while taking Pradaxa have a greater chance of a hematoma (a solid, blood-filled swelling) in the spinal cord or its covering.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.