Health regulators in Canada have issued a warning on the new blood thinner Pradaxa, sold in Canada as Pradax. The new safety label will warn that the risk of internal bleeding events may be increased among patients with kidney problems, Health Canada announced earlier this month.
Pradax labels now recommend that all patients should have their renal function assessed before starting the drug, and that doctors should assess any changes in renal function for patients while on the medication, especially for patients who are 75 years of age and older. Health Canada also Pradax was not recommended for patients with rheumatic valvular heart disease, especially mitral stenosis, or patients with prostetic heart valves, as its safety and efficacy for these uses has not yet been established.
Pardaxa was approved in late 2010 by the United States Food and Drug Administration (FDA) for the prevention of strokes in patients who have a specific type of irregular heart beat. The drug, made by Boehringer Ingelheim, was introduced as an alternative to Coumadin, also known as warfarin, a blood thinner that has been on the market for years and carries a risk for bleeding. However, since Pardaxa became available, hundreds deaths have been associated with the drug caused by internal bleeding episodes that doctors could not stop. There currently is no antidote for Pardaxa.
In December 2011, the FDA announced that it was evaluating reports of bleeding events associated with Pradaxa use. The FDA has yet to make a recommendation, but lawsuits are already being filed against the makers of Pradaxa by and on behalf of patients who were injured while on the medication. Complainants claim that Boehringer Ingelheim should have put stronger warnings on the drug’s label or recalled the drug when reports of bleeding events began mounting.
Source: Health Canada