Posted from: Monday, December 28, 2015 - 10:55 AM - Present

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. 

 

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability. All trademarks are the property of their respective owners.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Monday, September 18, 2017 - 08:51 AM.