Canadian health regulators have added new label warnings to Pradaxa, the new blood thinner.
The Pradaxa warnings were announced on March 16, and recommend that all patients should have their renal or kidney function assessed before starting Pradaxa and that doctors should assess any changes in renal function while on the treatment, especially among patients over 75 years old.
Health Canada indicated that use of Pradaxa was not recommended for patients with rheumatic valvular heart disease, especially mitral stenosis, or patients with prosthetic heart valves, as the safety and efficacy of Pradaxa has not been studied among those patients.
Pradaxa (dabigatran) is a new blood thinner, which was touted by Boehringer Ingelheim as a superior alternative to Coumadin (warfarin) for prevention of strokes among patients with atrial fibrillation.
There are concerns about the risk of serious and potentially fatal bleeding events from Pradaxa among the medical community in the United States. Since the medication was introduced in the U.S. in October 2010, hundreds of deaths have been reported among Pradaxa users who experienced internal bleeding or hemorrhages that doctors were unable to stop.
No Antidote for Pradaxa
There is no antidote to the bleeding side effects of Pradaxa, short of dialysis.
Institute for Safe Medication Practices Report
According to a report released by the Institute for Safe Medication Practices in January 2012, more instances of Pradaxa hemorrhages were reported to the FDA’s Adverse Event Reporting System during the first quarter of 2011 than were reported in association with any other drug monitored by the group. At least 505 instances involving Pradaxa bleeding events were reported, compared to 176 cases reported with warfarin/Coumadin, which was second on the list.
FDA Investigates
The United States Food and Drug Administration has issued a safety announcement about the anticoagulant drug dabigatran, marketed as Pradaxa®. This information is based on the FDA's review of post-marketing reports of serious, and even fatal, bleeding events in patients taking Pradaxa®.
The possible increased risk of serious bleeding events with Pradaxa® is confirmed by medical studies. A recent study also found an increased risk of heart attack or acute coronary syndrome with Pradaxa® as compared to other treatments.
In December 2011, the FDA announced that it was evaluating post-marketing reports on the Pradaxa bleeding events to determine if there is anything abnormal about the side effects of Pradaxa, and whether the anticoagulant may pose an unreasonable risk for certain consumers.
Pradaxa Lawsuits
Some lawsuits have been filed throughout the United States after patients have experienced severe bleeding problems. The lawsuits allege that Boehringer Ingelheim failed to adequately research the side effects of their medication. When it became apparent that the risk of bleeding events were causing a number of serious injuries throughout the United States, the drug maker should have provided stronger warnings or issued a Pradaxa recall, according to many of the complaints filed.
