Health Canada is the equivalent of the Food & Drug Administration for the Canadian provinces. The Canadian government has regulated the marketing and sale of drugs in Canada for more than 100 years. The first regulations were passed in 1909 and were mostly geared towards protection of proprietary formulas. In 1919, the Department of Health was formed, and, one year later, in 1920, the Food & Drugs Act was passed by the Canadian parliament. Beginning in the early 1950s, drug manufacturers were required to file New Drug Applications, similar to those submitted to the FDA. Today, a drug company will receive a Notice of Compliance from Health Canada once its New Drug Application has been reviewed and approved by Canadian regulators. The Notice of Compliance may place a number of obligations on the drug manufacturer beyond the requirements for filing and monitoring adverse event reports.
Below is a summary of the key regulatory events that have occurred in Canada with regard to the approval of Pradax (also known as dabigatran etexilate and marketed as Pradaxa in the United States):
June 10, 2008 – Boehringer Ingelheim received a Notice of Compliance from Health Canada for the marketing of Pradax to patients for the prevention of blood clots in patients who have undergone total hip or knee implant surgeries.
October 2010 – Health Canada approved Pradax for the prevention of strokes and systemic embolic events in atrial fibrillation patients who require anti-coagulation mediations. This Canadian approval occurred shortly after the drug was approved by the FDA for marketing in the United States. Health Canada’s approval was based upon finding from the RE-LY study which Boehringer claims show an additional 35% reduction in strokes over the reduction seen in atrial fibrillation patients taking Coumadin. Boehringer also claims that the RE-LY study shows that the bleeding risks associated with Pradax are similar to the bleeding risks faced by patients taking warfarin or Coumadin, a major point of contention in the burgeoning national Pradaxa litigation.
November 10, 2011 – Health Canada issued an alert to consumers and physicians regarding mix-ups between Pradax and Plavix. This Health Canada alert also pointed out that (1) Pradax is not associated with the same food and drug interactions long associated with use of Coumadin, and (2) that there is no antidote for Pradax patients who have the misfortune of suffering from a bleeding episode while taking the drug.
March 21, 2012 – An advisory was issued by Health Canada to physicians alerting them of changes to the warning label and instructions for use (also known as a Product Monograph) for Pradaxa. These changes in the warnings for Pradax highlight several critical issues that have led to Pradax-induced patient injuries and deaths in the past:
That renal impairment is a risk factor for bleeding problems for patients taking Pradax;
That patients with a pre-existing history of bleeding problems or those at high risk for bleeding problems should not be prescribed Pradax;
That patients should be closely monitored for signs of bleeding or anemia;
That Pradax should be discontinued at the first signs of a bleeding problem and the source of the bleeding be investigated;
That Pradax should not be used in patients with severe renal impairment;
That patients need to have a creatinine clearance test performed prior to initiation of Pradax therapy to exclude the existence of severe renal impairment;
That patients taking Pradax need to be monitored for signs of a change in their renal function such as hypovolemia, dehydration, and use of medications that might worsen kidney function;
That impaired renal function may increase the levels of dabigatran in a patient; and
That elderly patients (defined as 75 years of age or older) or patients with moderate renal impairment (defined as creatinine clearance levels of 30-50 mL/min) require annual monitoring of their kidneys while taking Pradax.
The lawyers at Searcy Denney Scarola Barnhart & Shipley represent patients who have been injured or died as a result of their ingestion of Pradaxa. The firm has taken a leadership role in the national litigation including having one of the first-filed cases as well as helping to coordinate the national litigation efforts.