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Should the FDA Banish PPIs for Heartburn?

Do powerful acid-suppressing drugs for indigestion raise the risk for catching COVID-19? A new study suggests that PPIs for heartburn may pose a problem.
Should the FDA Banish PPIs for Heartburn?
LLANO TX-AUG 16 2015: Bottle of Nexium against white background. The “Purple Pill” now sold in “Non-Prescription” size dosage.

Proton Pump Inhibitors (PPIs) are hugely popular. Doctors routinely prescribe these acid-suppressing drugs. People can also purchase them easily over the counter. No doubt you have seen them on drugstore shelves as esomeprazole (Nexium 24HR), lansoprazole (Prevacid 24HR) and omeprazole (Prilosec OTC). Such drugs are great at healing ulcers. However, we worry about the widespread use of PPIs for heartburn. That’s especially true now that a pre-print study published in the American Journal of Gastroenterology suggests that people taking PPIs may be at higher risk for catching the coronavirus. 

How Could PPIs for Heartburn Be Linked to COVID-19?

The authors of the new study point out that:

“Proton pump inhibitors (PPIs) increase the risk for enteric [intestinal] infections which is likely related to PPI-induced hypochlorhydria [low stomach acid].”

The stomach is normally a hostile environment for bacteria and other nasty pathogens. That includes coronaviruses. The predecessor to SARS-CoV-2 was SARS-CoV-1, also known as just plain SARS. When the pH of the stomach is equal to or less than 3, the “infectivity” of the virus is impaired. In other words, when there is normal acid in the stomach, viruses have a hard time surviving and multiplying.

By suppressing stomach acid, PPIs could conceivably make it easier for SARS-CoV-2 to set up housekeeping in the intestinal tract. That could lead to inflammation and the spread of the virus to other places in the body, including the lungs.

PPIs and COVID-19

The new research involved an online survey of 86,602 people. Of that total, 3,386 reported a positive COVID-19 test result. That was 6.4% of the total participants. People who were taking PPIs for heartburn were twice as likely to have a positive COVID test than individuals not taking PPIs. If people took PPIs two times a day, they were nearly four times more likely to have tested positive for the coronavirus.

Here, in the words of the authors, are their observations:

“In a large, nationwide study, we found that use of PPIs is associated with increased odds for reporting a positive COVID-19 test. The highest risk is seen among individuals taking PPIs twice daily—a common practice in both primary and secondary care—as they are nearly four- times more likely to report COVID-19 positivity when compared to those not on PPIs.”

The authors admit that there are limitations to their study. It was observational, not a randomized controlled trial. Hospitalized patients were not likely to take the survey. There may have been bias introduced in the study, since people might not recall their drug history accurately or the testing for COVID-19. There were a few other potential problems with the online survey.

However, the authors go on to say:

“These potential limitations notwithstanding, there is biological plausibility for our findings as the similar SARS-CoV-1 is pH-sensitive and remains infective at a pH >3; twice daily PPI use can lead to 24-hour median intragastric pH >6 and sustain pH >4 for more than 20 hours. We also found evidence of a dose-response relationship as those using PPIs twice daily have higher odds for COVID-19 positivity when compared to those taking lower-dose PPIs or those not using PPIs at all.”

The authors did not discover a relationship between use of other heartburn medicines such as H2 antagonists like cimetidine (Tagamet) or famotidine (Pepcid) and COVID-19.

What to Do About PPIs for Heartburn?

We would be the first to admit that any relationship between PPIs and vulnerability to COVID-19 is speculative at this time, despite biological plausibility. We will need much more rigorous research before we will have a definitive answer about a possible connection between proton pump inhibitors and the novel coronavirus.

There are other considerations, however. Over the last several years we have observed a surprisingly large number of potentially serious complications associated with PPIs for heartburn. They include:

  • C. difficile intestinal infections
  • Pneumonia
  • Kidney damage
  • Cardiovascular complications
  • Dementia
  • Bone fractures
  • Liver damage
  • Thyroid problems
  • Premature death

We are starting to wonder whether the FDA should reconsider the OTC use of PPIs for heartburn when there are so many other options that seem much safer. When a physician is prescribing PPIs for stomach ulcers, we do not have a problem. That’s because the doctor can monitor progress and help the patient discontinue the PPI when it is no longer necessary. When people can take PPIs for heartburn without any medical supervision, it makes us nervous.

Do People Read Labels?

The FDA seems content with requiring the following message on the label of PPIs for heartburn:

“do not use for more than 14 days unless directed by your doctor; you may repeat a 14-day course every 4 months

“do not take for more than 14 days or more often than every 4 months unless directed by a doctor.”

We wonder how many people read these directions. Even more important, how many follow them? When people take PPIs for heartburn for more than several weeks, they may develop rebound hyperacidity when they stop. That means that their symptoms may come back with a vengeance when they discontinue the PPI.

If you would like to learn much more about the pros and cons of PPIs for heartburn you may wish to read our newly revised and expanded eGuide to Overcoming Digestive Disorders. This electronic resource is available in the Health eGuide section of this website. You will also learn about alternatives to PPIs for heartburn. For example, famotidine (Pepcid) may actually help improve outcomes if patients develop COVID-19 (Gut, June 4, 2020).

Although this was a small, 10-patient case series, the authors conclude: 

“The results of this case series suggest that high-dose oral famotidine is well tolerated and associated with improved patient-reported outcomes in non-hospitalised patients with COVID-19.”

This is not the first report of famotidine vs. COVID-19.

A study published in the journal Gastroenterology (online, May 22, 2020) concluded:

“This retrospective study found that, in patients hospitalized with COVID-19, famotidine use was associated with a reduced risk of clinical deterioration leading to intubation or death…The results were specific for famotidine (no protective association was seen for PPIs) and also specific for COVID-19 (no protective association in patients without COVID-19).”

The People’s Pharmacy Perspective:

Most people think that over-the-counter PPIs for heartburn are perfectly safe. The new report suggesting that there may be an association between PPI use and susceptibility to COVID-19 is worrisome. But it needs corroboration.

No one should ever stop taking a PPI suddenly. Rebound hyperacidity and severe heartburn symptoms could result. If you are under a physician’s care, ask your doctor about this study in the highly regarded American Journal of Gastroenterology. If you are taking PPIs for heartburn, you may want to consult our eGuide to Overcoming Digestive Disorders to learn about other options. 

Please share your thoughts about PPIs and other treatments for indigestion in the comment section below. If you think this article might be of interest to a family member or a friend, please share it by scrolling to the top of the page and using one of the icons for email, Facebook or Twitter. Thank you for supporting our work in this manner.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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Citations
  • Almario, CV et al, "Increased Risk of COVID-19 Among Users of Proton Pump Inhibitors." American Journal of Gastroenterology, Preprint, online, July 7, 2020.
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