FDA Finds Pradaxa Linked to Lower Stroke, Brain Hemorrhage Risk

By Dow Jones Business News, 
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By Thomas M. Burton

A Food and Drug Administration analysis released Tuesday found the blood thinner Pradaxa was better at avoiding strokes and brain hemorrhage than a decades-old alternative, though it was linked to more stomach bleeding.

The findings help alleviate some safety concerns about Pradaxa, a drug from Boehringer Ingelheim GmbH. But the bleeding risk has been the subject of thousands of lawsuits, and the study doesn't eliminate existing concerns about that risk.

The new drug was compared with warfarin, a decades-old drug commonly sold in generic form. Both medicines are given mostly to reduce the risk of stroke in patients with a commonly occurring abnormal heart rhythm called atrial fibrillation. It can cause blood to pool in the heart and over years create clots that can float to the brain and cause strokes.

Blood thinners can reduce the stroke risk, but the question has been whether they pose too much of a bleeding risk in some patients.

The FDA analyzed records of 134,000 patients on the Medicare insurance program for people 65 and older and the disabled. It plans to write a complete report in a medical journal, but in the meantime disclosed the basic findings about Pradaxa, whose generic name is dabigatran.

The FDA found that Pradaxa patients had 20% fewer clot-based strokes and 66% fewer intracranial bleeding episodes, compared with warfarin. It also was linked to a slight reduction in death, of 14%.

But when it came to major gastrointestinal bleeding, there was a 28% increase in such events with Pradaxa.

Boehringer Ingelheim said it is "pleased" with the results of the FDA analysis, finding them consistent with its own research. "These findings are particularly notable given the study...was based on a much larger and older population than analyzed before," the company said in a written statement. It called Pradaxa "an important treatment option to reduce stroke risk" in certain patients.

Bristol-Myers Squibb Co., which makes a brand name version of warfarin called Coumadin, said it had no comment on the FDA study.

The FDA analysis included new users of Pradaxa and warfarin who received a diagnosis of atrial fibrillation in the six months prior to when medication was dispensed. FDA officials didn't immediately respond to detailed questions about the study, but the analysis appeared to follow patients for a short time, a little over three months.

It is typical in medical studies for authors to try to adjust for confounding variables--such as variations in age, other illness and smoking--that could skew the results.

In this case, the FDA said it adjusted for "many" such variables but that "confounding from other unmeasured factors may be present." The agency declined to be specific about such factors.

Warfarin is an inexpensive medicine that has been successful for decades for stroke risk reduction, but it requires frequent testing to ensure that the drug is present in the bloodstream at proper levels. Newer drugs like Pradaxa don't generally require such testing.

Write to Thomas M. Burton at tom.burton@wsj.com

Subscribe to WSJ: http://online.wsj.com?mod=djnwires


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