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Proton Pump Inhibitors

Proton pump inhibitor drugs (PPIs) are a type of medication intended to decrease stomach acid. One common use is to alleviate symptoms of frequent, chronic heartburn, also called GERD, or gastroesophageal reflux disease.

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There are 30 million Americans who are regular users of different types of proton pump inhibitor drugs. 1 In fact, PPIs are among the top 10 types of drugs prescribed to patients receiving Medicare benefits. 2 These drugs are prescribed for Americans who suffer from acid reflux, many of whom complain of symptoms while sleeping, as well as related conditions.

Symptoms of acid reflux may include a burning sensation in the chest and throat, a sour taste in the mouth, difficulty swallowing (dysphagia), dry cough, hoarseness or sore throat, and chest pain. Sufferers may regurgitate food or stomach acid. Some describe feeling as though they have a lump in their throat. 3

PPIs have been available in the U.S. by prescription since 1990, and many can now be purchased over-the-counter (OTC). 4 While these drugs may relieve discomfort from heartburn, concerns have been raise of the safety of PPIs and potential side effects.

They work by blocking the production of stomach acid, giving damaged esophageal tissue time to heal. When the esophagus is functioning properly, its sphincter muscle prevents the backwash of stomach acid from coming up and causing painful irritation and damage characteristic of GERD and heartburn. 5

Popular Proton Pump Inhibitor Brands

Doctors prescribe proton pump inhibitors for heartburn and to “prevent and treat ulcers in the duodenum (where most ulcers develop) and the stomach” and esophageal inflammation. 6

Familiar brand names of PPIs include:

  • Nexium & Nexium 24 HR (esomeprazole)
  • Prilosec & Prilosec OTC (omeprazole)
  • Prevacid & Prevacid 24 HR (lansoprazole)
  • AcipHex & AcipHex Sprinkle (rabeprazole)
  • Protonix (pantoprazole)
  • Zegerid & Zegerid OTC (omeprazole with sodium bicarbonate)
  • Dexilant & Dexilant SoluTab (dexlansoprazole) 7

Drug Interactions with PPI Medications

Proton pump inhibitors may interact with certain drugs. One example is clopidogrel, sold in the U.S. under the brand name Plavix. 8

Clopidogrel is intended to reduce the possibility of blood clot formation in arteries. People who are at risk of a heart attack or stroke may be prescribed this medication. 9

In 2009, the U.S. Food and Drug Administration (FDA) issued a warning that patients should not mix clopidogrel with certain acid reflux drugs. 10The FDA warns that taking clopidogrel with omeprazole may reduce the medication’s efficacy.

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The available data show that patients at highest risk for fractures received high doses of prescription PPIs (higher than OTC PPI doses) and/or used a PPI for one year or more.

FDA Revision and Fracture Risk

The FDA has determined that proton pump inhibitors have been associated with the possibility of an increased risk of adverse events, like certain bone fractures, the potential to lower magnesium levels, and an association with a type of bacteria that can cause severe diarrhea. 11

In 2010, the FDA determined that it was necessary to revise the prescription and over-the-counter (OTC) PPI labels “to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications.” 12 In 2011, “Following a thorough review of available safety data, FDA has concluded that fracture risk with short-term, low dose PPI use is unlikely. The available data show that patients at highest risk for fractures received high doses of prescription PPIs (higher than OTC PPI doses) and/or used a PPI for one year or more.” 13

Studies Linking PPIs to Pneumonia

Several studies have demonstrated a possible link between taking PPIs and increased likelihood of developing pneumonia. It is thought that stomach acid “creates a fairly inhospitable environment for bacteria, but if acid levels are reduced by PPIs, the bacteria count can go up.” 14

If this occurs and “bacteria-laden stomach content” moves up into the esophagus, an individual could potentially inhale that unhealthy bacteria and develop pneumonia. 15

Kidney Damage From PPIs

Depending on the type and extent of the damage, a person could develop:

  • Chronic kidney disease (CKD)

  • Inflammation within the kidneys known as interstitial nephritis

  • A severe and sudden type of damage called acute kidney injury (AKI), also called acute renal failure

  • End-stage renal disease, also called kidney failure. 16

PPIs and Potential Kidney Side Effects

Concerns have surfaced that taking certain types of PPIs, like Nexium or Prilosec, may be linked with kidney damage. All of the conditions are characterized by reduced kidney function. Depending on the specific circumstances, a person’s kidneys may slowly lose their ability to filter waste products or may rapidly lose their ability to function. 17

When the kidneys are damaged or begin to fail, waste products and fluids can build up in the body. Immediate treatment in a hospital setting or kidney biopsy may be necessary. 18

In extreme situations, a person may require kidney dialysis or a kidney transplant. In worst-case scenarios, a person can have severe complications and die from their kidney-related problems. 19

Individuals suffering from renal failure may experience other complications as well, due to or exacerbated by their kidney problems. These include heart failure, an irregular heartbeat, and lung-related complications. 20

While kidney damage can be a serious condition and lead to further complications, there has not been a PPI recall at this point in time. However, in 2011 the FDA recommended that delayed-release orally disintigrating tablets of lansoprazole, manufactured by Teva, may clog and block oral syringes and feeding tubes. The medication is under review.

H2 Blockers for Treating Mild Heartburn

Low-dose versions of H2 blockers are considered relatively cheap, safe, effective over-the-counter medication that may alleviate symptoms of mild to moderate, and occasional, heartburn. 21

  1. http://seattletimes.com/html/health/2025372239_pharmacy11xml.html 

  2. http://www.internationaljournalofcardiology.com/article/S0167-5273(14)01738-0/abstract 

  3. http://www.mayoclinic.org/diseases-conditions/gerd/basics/symptoms/con-20025201 

  4. http://en.wikipedia.org/wiki/Discovery_and_development_of_proton_pump_inhibitors 

  5. http://en.wikipedia.org/wiki/Proton-pump_inhibitor 

  6. http://www.health.harvard.edu/diseases-and-conditions/proton-pump-inhibitors; http://www.fda.gov/Drugs/DrugSafety/ucm290510.htm  

  7. http://www.fda.gov/Drugs/DrugSafety/ucm290510.htm 

  8. http://www.health.harvard.edu/diseases-and-conditions/proton-pump-inhibitors; http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm225843.htm 

  9. http://www.health.harvard.edu/diseases-and-conditions/proton-pump-inhibitors  

  10. http://www.health.harvard.edu/diseases-and-conditions/proton-pump-inhibitors 

  11. http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm;http://www.fda.gov/Drugs/DrugSafety/ucm245011.htm 

  12. http://www.health.harvard.edu/diseases-and-conditions/proton-pump-inhibitors; http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213206.htm  

  13. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213206.htm 

  14. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213206.htm 

  15. http://www.health.harvard.edu/diseases-and-conditions/proton-pump-inhibitors 

  16. http://archinte.jamanetwork.com/article.aspx?articleid=2481157; http://bmcnephrol.biomedcentral.com/articles/10.1186/1471-2369-14-150; http://journals.lww.com/md-journal/Fulltext/2016/04120/Association_Between_the_Use_of_Proton_Pump.59.aspx; http://cmajopen.ca/content/3/2/E166.short 

  17. http://www.niddk.nih.gov/health-information/health-communication-programs/nkdep/learn/causes-kidney-disease/kidney-disease-basics/Pages/kidney-disease-basics.aspx; https://www.nlm.nih.gov/medlineplus/ency/article/000464.htm; https://www.nlm.nih.gov/medlineplus/ency/article/000500.htm 

  18. http://www.niddk.nih.gov/health-information/health-communication-programs/nkdep/learn/causes-kidney-disease/kidney-disease-basics/Pages/kidney-disease-basics.aspx; https://www.nlm.nih.gov/medlineplus/ency/article/000464.htm; https://www.nlm.nih.gov/medlineplus/ency/article/000500.htm 

  19. http://www.niddk.nih.gov/health-information/health-topics/kidney-disease/hemodialysis/Pages/facts.aspx; https://www.nlm.nih.gov/medlineplus/kidneyfailure.html  

  20. http://www.ncbi.nlm.nih.gov/pubmed/18565479; http://jasn.asnjournals.org/content/2/6/1053.abstract  

  21. http://www.mayoclinic.org/drugs-supplements/histamine-h2-antagonist-oral-route-injection-route-intravenous-route/description/drg-20068584