Product News and Recalls

Study: Risky Pradaxa blood clot treatment may be unnecessary

A randomized, double-blind clinical trial indicates that aspirin works just as well as the commonly prescribed blood thinner warfarin in preventing blood clots.

According to a report in the New York Times, this is significant because aspirin is easier to take. Warfarin requires a monthly blood test, and also restricts activities for patients because of its tendency to cause bleeding.

The anti-coagulant Pradaxa was ostensibly designed to replace warfarin, based on manufacturer Boehringer Ingelheim Pharma’s claims that Pradaxa doesn’t require frequent blood tests.

But a number of studies have indicated that Pradaxa causes complications including excessive bleeding. Last year, Pradaxa’s manufacturer reported a link between the drug and at least 260 deaths.

The study comparing warfarin and aspirin, published online in The New England Journal of Medicine, involved 2,305 patients with heart failure and normal heart rhythm. Half received regimens of warfarin and dummy aspirin, the other half aspirin and dummy warfarin.

Researchers followed them for up to six years, tracking incidents of stroke, hemorrhage and death, and found no significant overall difference between the two drugs.

Patients who took warfarin were significantly less likely to have a stroke, but that advantage was canceled out by an increased likelihood of gastrointestinal bleeding and other hemorrhages. There were no significant differences in heart attacks or hospitalizations for heart failure.

Patients should consult their doctors before making any changes in their medication. A consultation with a Pradaxa lawyer is also important if there are significant injuries.

See the report here:[]