This Is MS Multiple Sclerosis Community: Knowledge & Support

WASHINGTON -- The FDA said it will begin a safety review of reports of excess bleeding associated with dabigatran (Pradaxa), an oral direct thrombin inhibitor that is approved for prevention of stroke in patients with nonvalvular atrial fibrillation.

The FDA's announcement comes a month after post-marketed reports of about 50 cases of fatal bleeding worldwide surfaced.

The FDA said it wants to determine whether the reports of bleeding are occurring more commonly than would be expected.

In the RE-LY clinical trial, which compared two doses of dabigatran (150 mg bid and 110 mg bid) with warfarin in more than 18,000 patients, the bleeding rates between the two arms were similar.

When the FDA approved the drug in October 2010, it limited its approval to two doses: 150 mg bid and 75 mg bid, a decision that was immediately questioned because the 75 mg dose had never been tested in a clinical trial. Last spring, the New England Journal of Medicine published a commentary in which two FDA researchers involved in the approval decision explained the agency's reasoning, acknowledging a prevailing concern about the potential for excess bleeding.

When the bleeding reports surfaced last month, a spokesperson for drug-maker Boehringer Ingelheim said dabigatran's safety profile was in line with that seen during the clinical trial.

In the meantime, the FDA said that at this time it "believes 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." The agency advised patients to keep taking the drug and to consult their physicians if necessary.

Comparing drugs and dosage post CCSVI is dangerous because we are all different (pwMS are more different than the average)

•Let your healthcare provider know if you develop any signs of bleeding, such as:

◦Easy bruising
◦Cuts or scrapes that are slow to stop bleeding
◦Black, tarry stools; bright-red blood in the stool; or vomiting of blood (signs of gastrointestinal bleeding)
◦Signs of bleeding in the brain, such as vision or speech changes, weakness or numbness in an arm or leg, or a severe headache.

A big concern with all these drugs is the effect of renal function. Many of these deaths may be due to over-anticoagulation because kidney failure is not recognized or detected before administering these drugs which are metabolized through the kidney ..If the kidney doesnt do its job, then drug accumulates and renders the patient totally over angicoagulated.

European regulators last month said that patients about to take Pradaxa should have their kidneys checked, and Japanese regulators told Boehringer in August to issue a strong warning to doctors of potentially deadly bleeding as a result of use of Pradaxa.

Pradaxa Holds No Extra Bleeding Risk, FDA Says