According to Cleveland Clinic researchers, Pradaxa patients taking the new anti-clotting drug Pradaxa have a 33% higher risk of heart attack or severe symptoms of heart disease than do patients taking warfarin.
This finding, from Ken Uchino, MD, and Adrian V. Hernandez, MD, PhD, is based on data from seven clinical trials that enrolled 30,514 patients.
According to Uchino and Hernandez, “the risk of [heart attack] or acute coronary syndrome is increased with [Pradaxa] compared with various control treatments, which include adjusted-dose warfarin, [Lovenox], or placebo.”
Archives of Internal Medicine
The editorial accompanying the study in the Jan. 9 issue of Archives of Internal Medicine, journal editor Rita Redberg, MD, notes that this isn’t the first safety warning issued for Pradaxa.
FDA Is Investigating Pradaxa Side Effects
The FDA is investigating an unusually large number of adverse reports of serious bleeding linked to the drug. Japan and Australia already have issued a safety warning. The European Medicines Agency advises doctors to check patients’ kidney function before prescribing Pradaxa. And last year the FDA warned patients that the drug breaks down quickly when removed from its original container.
According to Kirk Garratt, MD, clinical director of interventional cardiology research at New York’s Lenox Hill Hospital, “that’s still an important added risk for patients who may already be piling up risk factors for heart disease.”
Garrett continues, “if I have a patient on this drug for 10 years, I’d expect a 5% increased lifetime risk of heart attack.”
“The most important aspect of this study is that it allows us to see a consistent risk across studies and types of patients. That speaks to the conclusion that this study is well done and that the risk is real.”
SOURCES:Uchino, K. Archives of Internal Medicine, published online Jan. 9, 2012.Redberg, R.F. Archives of Internal Medicine, published online Jan. 9, 2012.Jacobs, J.M. Archives of Internal Medicine, published online Jan. 9, 2012.Hohnloser, S.H. Circulation, published online Jan. 3, 2012.FDA Safety Communication, March 29, 2011.FDA Safety Communication, Dec. 12, 2011.Institute for Safe Medical Practices, Quarterwatch, Quarter 4, 2010.Ansell, J. Circulation, January 2012.Granger, C.B. Circulation, January 2012.