PPIs and Death: Why Are These Acid-Suppressors still OTC?

PPIs (aka proton pump inhibitors) remain incredibly popular. These acid-suppressing drugs help heal ulcers. That’s a really good thing. For short term use, they’re terrific! The trouble is that they are overprescribed for a wide variety of vague gastrointestinal symptoms. And the FDA seems to think these drugs are so safe that the agency has allowed them to be sold over the counter (OTC).

More Bad News about PPIs:

These heartburn drugs may not be as innocuous as they might seem. PPIs are better known by their brand names-Nexium, Prevacid and Prilosec. They are also available generically as esomeprazole, lansoprazole and omeprazole.

Over the past several years, a number of serious adverse effects have come to light. They include an increased risk of infections such as pneumonia and Clostridium difficile, weakened bones, poor absorption of nutrients such as calcium, iron, magnesium, zinc and vitamin B12, heart attacks, kidney disease and dementia.

PPIs and Death:

Investigators used a large database of more than 3 million VA patients to determine that PPIs increase the likelihood of death over a six-year span (BMJ Open, July 4, 2017). The scientists used patient records to compare people who had received a new prescription for a PPI to those who did not take any acid-suppressing drugs as well as to those who took a different, less powerful acid-reducing medicine such as cimetidine or ranitidine. They found that people taking PPIs were about one-fourth more likely to die during the study.

The FDA’s Soft Spot for Drugs:

Once the FDA makes a decision that a class of drugs is safe enough to be sold without prescription it has a really hard time changing direction. Even death does not seem to be a problem for the FDA.

Imagine, though, that an herb such as black cohosh or echinacea were found to cause kidney damage or osteoporosis. What if an FDA staffer discovered that a probiotic formulation increased the risk of heart attacks or death? The hue and cry would be deafening. There would be instant press releases from the FDA about these grave dangers. We would see headlines and interviews on the evening news shows. Shortly thereafter, there would major efforts to limit access to such supplements. The FDA might even consider banning them outright.

As far as we can tell, the FDA does not seem alarmed by the recent reports about PPIs. There is certainly no mention of withdrawing such drugs from OTC status. That means you are on your own.

DO NOT stop PPIs Abruptly!

No one should ever stop a PPI suddenly, as that might trigger rebound hyperacidity and severe symptoms of indigestion. The authors of this paper in BMJ Open suggest that PPIs should be used for a limited amount of time and only when there is a clear medical indication and where benefits outweigh risks.