Study Suggests Pradaxa Side Effects

Cleveland, OHA new study suggests patients could be at risk of Pradaxa side effects. Although there have been reports of serious side effects such as Pradaxa bleeding, the new study reportedly found an increased risk of heart attack or heart disease linked to the use of Pradaxa.

According to WebMD (01/11/12), researchers from the Cleveland Clinic found that patients who take Pradaxa have a 33 percent higher risk of heart attack or symptoms of heart disease than patients taking warfarin. Pradaxa is a new anti-clotting medication designed to replace warfarin and other older, anti-clotting medications. Pradaxa was also found to have a higher risk of heart attack or symptom of heart disease than Lovenox or than a placebo.

The study, published in the January 9, 2012, issue of Archives of Internal Medicine, noted that overall the risk of heart attack is still small, despite the increase in risk over other medications. Of 20,000 patients who used Pradaxa, 237 had either a heart attack or chest pain. That is compared with 83 patients of more than 10,000 who took warfarin or a placebo. Experts noted, however, that for patients who may already have other risk factors for heart attack, the added risk associated with Pradaxa may be of concern.

Researchers analyzed seven clinic trials—involving almost 40,000 patients—that compared the use of Pradaxa with that of warfarin, Lovenox and/or a placebo. They found that Pradaxa was "significantly associated with a higher risk" of heart attacks and chest pain, according to Bloomberg (01/09/12). They concluded, "Clinicians should consider the potential of these serious harmful cardiovascular effects with use of dabigatran [the generic name for Pradaxa]." Researchers further suggested that more studies be conducted into the risk of heart problems linked to Pradaxa.

The FDA has said it is investigating reports of serious bleeding linked to Pradaxa.

A spokesperson for Boehringer Ingelheim said the company does not agree with the results of the study. He noted that a company-funded study did not find that the risk of heart attack was significantly increased in patients who used Pradaxa.

Pradaxa is approved for the prevention of strokes in patients who suffer from atrial fibrillation.