FDA Considers Acid Blockers Warning

The FDA is considering ANH’s petition to add a pneumonia warning on acid blocker medications. Let’s keep up the pressure to make sure it happens. Action Alert!

Last year, ANH submitted a Citizens Petition to the FDA calling for the addition of a pneumonia warning on all proton pump inhibitor (PPI) medications. The FDA’s interim response letter can be reviewed here. It is good news that the FDA is considering the case put forth by the petition, but we must hold the agency’s feet to the fire to ensure they do the right thing. 

To briefly recap: PPI’s block the production of stomach acid and are used to treat heartburn and GERD (gastroesophageal reflux disease). PPIs have been linked with increased risk of pneumonia,  which is of particular concern with COVID-19 and the respiratory damage that characterizes advanced cases. 

The mechanism by which PPIs cause pneumonia is not fully understood, but one theory is that they compromise the stomach’s “acid mantle” against gastric colonization of bacteria.  Normally, gastric pH is around 2, which effectively limits bacterial colonization from ingested microbes; PPIs increase this pH to above 4 for approximately 24 hours, compromising this natural defense mechanism. PPIs may also lead to delayed gastric emptying, increased gastric contents, larger bacterial loads, and increased pressure on the lower esophageal sphincter, causing reflux that brings bacteria back up into the respiratory tract and thus increases the likelihood of infection. Another theory is that PPIs reduce the acidity of the upper digestive tract which results in increased bacterial colonization of the larynx, esophagus, and lungs. 

PPIs also impact the gastrointestinal microbiota, which could reduce immunity and increase pneumonia risk. This is key. We’re living through a viral pandemic that attacks the respiratory system. Not only do PPIs weaken our immune response overall, but they also make us more susceptible to a respiratory infection that could put us more at risk for COVID-19 complications. 

There are an estimated 4.9 million cases of pneumonia in the US per year, requiring more than 250,000 hospitalizations and resulting in 50,000 deaths. The cost of treating pneumonia in the US is estimated to be $13.4 billion. PPIs could be costing us billions of dollars a year in healthcare costs for pneumonia alone, not to mention the other health hazards they cause. 

Keep in mind that acid blockers like PPIs also do not address the root cause of stomach trouble, which is often too little stomach acid, not too much. This means that in many cases, taking acid blockers simply makes your stomach problems even worse. Public health experts say between 60 and 70% of people who take these drugs don’t need them. 

The FDA already has issued a number of warnings regarding PPIs, including the increased risk of bone fracture, hypomagnesemia (low serum magnesium levels), and Clostridium difficile associated diarrhea. It’s time to add pneumonia to this list, especially given the increased danger as we weather this pandemic. 

Action Alert! Write to the FDA, with a copy to Congress, telling the agency to add a warning that PPIs increase risk of pneumonia. Please send your message immediately.