Dabigatran (marketed in Canada as Pradax) is an anticoagulant drug (in a class called Direct Thrombin Inhibitors) and was approved by Health Canada (and other regulatory bodies in other countries) within the past year.
This new drug showed a lot of promise as a safer alternative to warfarin, which is notorious for a number of serious side-effects, many of them leading to death. In fact, I believe it was earlier this year that the Canadian Cardiovascular Society released a position statement now recommending dabigatran as the first-line therapy to prevent blood clots in those with atrial fibrillation.
Dabigatran was suppose to be safer--resulting in less major bleeding, and complications than warfari (including being easier to use than warfarin, which has many drug-drug/nutrient/food interactions, requires constant monitoring, takes up huge healthcare resources for testing, physicians' time, etc.).
I initially thought this was great news because, IMO, warfarin is one of the worst drugs to be taking, specifically because it inhibits the activity of vitamin K (read the discussion HERE). However, it now seems that the honeymoon is over for dabigatran. Recent reports are suggesting that the drug causes even more deaths than warfarin, and is now under a safety review by the US FDA.
In the big picture, dabigatran may still be preferred over warfarin (again, just IMO...though many may disagree), but it's definitely not good news for the drug.
Source: FDA Drug Safety Communication: Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate)
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