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Pradaxa Warning Labels Updated in Canada

Canadian health regulators have required new warning labels to be added to Pradaxa indicating the risk of internal bleeding may be increased in patients with pre-existing kidney problems.

Canadian health regulators have required new warning labels to be added to Boehringer-Ingelheim’s controversial blood thinner Pradaxa (generic: dabigatran) indicating the risk of internal bleeding may be increased in patients with pre-existing kidney problems. 

Free Pradaxa Lawsuit Evaluation: If you or a loved one has been injured by Pradaxa, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.

What’s the problem?

March 22, 2012 – In addition to the new recommendations concerning the use of Pradaxa in patients with kidney problems, Health Canada also indicated that the drug should not be used on individuals with rheumatic valvular heart disease, mitral valve stenosis, of prosthetic heart valves, as the safety of the medication has not been tested among these populations.

Pradaxa was manufactured to be a replacement for Coumadin (generic: warfarin), and is designed to require less monitoring and be easier to use. However, warfarin can be quickly counteracted by doses of Vitamin K when an internal bleeding problem occurs. This does not work with Pradaxa or any of the other newer generation of blood thinners such as Xarelto (generic: rivaroxaban).

The new warnings for Pradaxa in Canada come as controversy surrounding the drug mounts here at home in the United States and other countries. Since its release less than two years ago, hundreds of deaths have been reported among Pradaxa users who experienced catastrophic internal bleeding or hemorrhaging that doctors were unable to stop.

According to a January 2012 report released by the Institute for Safe Medication Practices, more hemorrhaging events linked to Pradaxa were reported to the FDA during the first quarter of 2011 than were reported with any other drug monitored by the group. During that time period, at least 505 Pradaxa bleeding events were reported, compared to just 176 cases reported in connection with Coumadin, which came in second on the list.

The new Canadian warnings are based on post-marketing reports of internal bleeding among elderly individuals being treated with Pradaxa, especially those with severe pre-existing kidney problems. The level of kidney impairment can be determined by calculating the person’s creatinine clearance (CrCl). A CrCl of less than 30 mL/min is designated as severe renal damage.

In December 2011, the U.S. Food & Drug Administration (FDA) announced that it was gathering data from Pradaxa internal bleeding post-marketing reports to determine whether there the drug poses any unreasonable risks for certain patients.

In recent months, a growing number of Pradaxa internal bleeding lawsuits have been filed in courthouses around the country. The complaints allege that Boehringer failed to adequately research its drug, and neglected to provide strong warnings about the potential complications involved with its use.

Do I Have a Pradaxa Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Pradaxa lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.

Free Confidential Case Evaluation: Again, if you or a loved one was injured by Pradaxa, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.

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