Clostridium difficile Infections, Deaths, Drugs Health Canada Warnings Insufficient, Contradictory

Further to information released on April 9 and April 30, today’s focus is on further concerns and promising solutions.  The Drug Safety & Effectiveness Network (DSEN) report of 2012 confirms concerns about the strong association between common stomach medications and C. difficile infections (CDI).

“If the regulator cannot or will not act in the public interest then it falls to policy makers to advance the public interest and adjust the mandate of the regulator.”

Today, I wish to draw attention to research that further links these medications with increased risk of the worst complications and with death from C. difficile.  A recent study found patients on PPIs had three times the risk of complications; analysis of factors contributing to death revealed only two independent associations: age (80+) 551%, and acid suppression 474%, (The Journal of Clinical Infectious Diseases, 2011; 53).

In summary, patients taking an acid suppressant were not only more likely to develop an infection (40 – 275%), they are 3x more likely among those with an infection to have the worst complications and 5x more likely to die of the infection.  These two are really the same issue since the elderly produce less stomach acid (achlorhydria, hypochlorhydria).

Dificid is heralded as a new third line of defence and a “new tool in the toolbox” to reduce the risk of recurrence. The cost is not made known but notice of ‘patient support’ with the cost could be an indicator.

Bio-K Plus has been demonstrated in clinical trials published in the American Journal of Gastroenterology (2010) to eliminate 95% of C. difficile infections.  The powerful probiotic therapy is started 36 hours after starting antibiotic therapy.  The authors note that: “standard treatment with metronidazole is inexpensive but has marginal efficacy whereas vancomycin is more effective but it is very expensive.  Furthermore AAD and CDAD often recur after treatment with either of these therapies and continued use compounds the growing worldwide problem of antibiotic resistance.”

While Health Canada (HC) does not normally promote any approved product, perhaps with 1400 deaths a year, even as warnings about risks should be communicated, perhaps HC could/should develop tools to communicate positive developments to hospitals, to doctors and patients when lives are at risk.

Finally, Scotland, recognizing the enormous over-prescription (estimated 70%), has already started a pilot program utilizing a specialty nurse that managed to take 83% of a target group off these high-risk and over prescribed medications without adverse effects.  (Quality in Primary Care 2012; 20:141-8)

Canada could have been there ten years ago; we have an opportunity to develop our own programs and work with the CMA and other stake holders to remedy this macabre situation.

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