A few days ago I published an article called fatalities involving the new drug Dabigatran. This has resulted almost immediately in a letter from the Media Group Director of the PR company that handles advertising for the pharmaceutical firm involved. I am glad to post it here:
“Just wanted to contact you with regard to your “Fatalities with Dabigatran and Warfarin Caused by Bleeding” article, and provide some further context about the analysis.
In particular, numerous factors can contribute to increased rates of spontaneous adverse event reporting and comparison of reporting rates across products is not methodologically supported due to biases which cannot be adequately controlled. The FDA has cautioned against comparing FAERS data across compounds. Randomized, controlled clinical trials, like the pivotal RE-LY trial, are the basis for determining the safety and efficacy profile of any medication.
In the way of more recent news, I’ve included the press release that BI issued yesterday around a new perspective from the FDA that was published online on March 13, 2013 in the New England Journal of Medicine. You’ll notice that the agency has not changed its recommendations regarding Pradaxa® (dabigatran etexilate mesylate) capsules, following the November 2012 Mini-Sentinel evaluations. The FDA stated that bleeding rates associated with new use of PRADAXA do not appear to be higher than those with new use of warfarin, which is consistent with observations from the pivotal RE-LY® trial.”
1. Unless there is evidence of erroneous reporting, neither the FDA or consumers can ignore a 16% fatal incidence in 2453 dabigatran associated bleeding events. Whether this holds true can only be verified or denied with independent non-company sponsored trials and clinical data.
2. Since June 20134 two new analyses have indicated there may be an increased risk of myocardial infarction (“Compared with warfarin (coumadin, sintrom) the risk of a myocardial infarction was increased 38%, while the risk of MI was 70% higher among dabigatran-treated patients compared with placebo-treated patients.”) A Dr Lip, who provided most of the counter arguments against these publications, is listed both as a consultant and featured Dabigatran speaker for the phartma comanies involved.