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The problem with the Purple Pill: The risk you should know about if you’re taking stomach ulcer meds

In our efforts to control the rampant spread of antibiotic resistant bacteria, a trend the World Health Organization calls a major threat to public health, Clostridium difficile has become a master of resistance and public enemy No. 1.

Not only does it have the ability to survive for months, if not years, in the environment, but it also can take advantage of any dysfunction in the human gastrointestinal tract to initiate infection. The only treatment for infection is antibiotics – which unfortunately leads to more resistance and the inability to treat.

According to Health Canada, the bacterium is regarded as one of the leading causes of infectious diarrhea in health care.

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Within the description of those susceptible to infection is a single sentence suggesting a risk to those who take prescription stomach ulcer pills, known in the medical community as proton pump inhibitors (PPIs). But a sole sentence is not enough.

These medications are better known in the public by the moniker "purple pill" thanks to the colour of one of the top-selling options, Nexium. Pharmacologically, these drugs, which include names such as Dexilant, Losec, Prevacid, Pantoloc, Tecta and Pariet, offer a relief from recurrent and at times dangerous heartburn.

In 2007, the problem with PPIs arose without much alarm. A few studies looking at the cause of infection in health care institutions found a link between C. difficile and these medications. Specifically, there was more than a three times greater odds of acquiring the bacterium.

Over the next few years, more studies solidified the clinical association, particularly in the elderly, people with suppressed immune systems and patients undergoing cancer therapy.

In 2012, Health Canada listened to the evidence and put out an advisory outlining the risk, and promised to investigate further.

The U.S. Food and Drug Administration developed a detailed description of the association of infection with continued use of PPIs. In addition, other problems relating to the use of PPIs, such as decreased vitamin and mineral absorption, iron deficiency and bone weakness began to appear in the literature.

For many in the scientific and medical communities, the sheen of the purple pill was fading and in many ways tarnished. Despite the evidence, there was push back, particularly on the link to C. difficile. A number of studies have since come out in support of PPIs, suggesting they pose either no or limited risk to infection. Those that saw a link suggested it was not due to the drug but some other problem with the patient, a so-called co-morbidity. Others simply dismissed the concept altogether. These dissenting voices muddied the waters, leaving regulators hard-pressed to look through the muck to find the right recommendations to follow.

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In Canada, Health Canada assigned this task to the Drug Safety and Effectiveness Network (DESN).

Earlier this year, the details of its report, albeit not publicly available, were shared with one Member of Parliament, Dr. James Lunney and stated there was a strong association of PPIs with C. difficile infection. In essence, Canada's own scientific experts confirmed the link.

Unfortunately, that was the end of the story. No other action was taken by Health Canada to advise the public and the medical community of the risk or of the potential for the spread of antibiotic resistance. To Lunney, however, this was unacceptable. He held press conferences, asked questions and offered assistance. He did everything possible to convince Health Canada to give this issue more than a sentence worth of notification. But he has seen little action. There are no timelines, no milestones and no mandate.

While the experts and the regulators continue to debate, other ways to deal with the problems leading to PPI prescriptions may lie not in the medicine but in our daily lifestyles, according to decades of research.

They include avoidance of fatty foods, coffee, soft drinks and processed chocolate as well as the inclusion of fibre, fruits, vegetables, licorice, peppermint and the herb curcumin. All of these measures help to keep stomach acid production down and the immune system balanced.

The natural route may not be effective for everyone and eventually pharmacologic routes may be necessary. Granted, lifestyle changes are never easy, but these may prevent symptoms from happening with no medical intervention needed. They may even limit the spread of resistant C. difficile and keep our antibiotic arsenal alive for years to come. For the sake of your ability to fight infections in the future, it's certainly worth the effort.

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