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Proton Pump Inhibitors

Proton pump inhibitors (PPIs) are medications work to decrease stomach acid production. They are used to treat symptoms of frequent heartburn for stomach disorders such as gastroesophageal reflux disease (GERD).

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Proton pump inhibitors are some of the most commonly prescribed medications in the U.S. and are regularly used by over 30 million Americans. They are routinely prescribed for people who have symptoms of acid reflux and are in the top 10 types of drugs given to Medicare patients.

Gastroesophageal reflux disease (GERD) is a disorder which causes frequent, chronic heartburn. People with GERD may experience symptoms such as a burning sensation in the chest or throat due to burping and regurgitation of food or stomach acid.  Over time, GERD may also cause difficulty swallowing (dysphagia), hoarseness of voice, sore throat, dry cough, and chest pain.

PPIs were first introduced as prescription medications in the U.S. in 1990 and several are now available over-the-counter (OTC) without a prescription. Though PPIs are often effective at alleviating symptoms of heartburn, they may cause side effects which are harmful and have raised safety concerns.

Normally, a sphincter muscle at the top of the stomach keeps acid from backing up into the esophagus. People with GERD have an esophageal sphincter which does not close adequately, allowing for reflux of highly acidic stomach contents. Over time, the esophagus may become inflamed and damaged due to acid exposure. PPIs work to treat GERD and other stomach conditions by blocking “proton pumps” which release stomach acid, allowing for esophageal tissue to heal.

Common Proton Pump Inhibitors

PPIs are prescribed to treat conditions like GERD and are used for the treatment and prevention of duodenal ulcers and peptic ulcer disease (PUD). They are also used as OTC medications for “chronic” heartburn, without a doctor’s prescription.

Popular PPIs include:

  • Omeprazole (Prilosec, Prilosec OTC)
  • Omeprazole / Sodium Bicarbonate (Zegerid, Zegerid OTC)
  • Esomeprazole (Nexium, Nexium 24 HR)
  • Lansoprazole (Prevacid, Prevacid 24 HR)
  • Dexlansoprazole (Dexilant, Dexilant Solutab)
  • Pantoprazole (Protonix)
  • Rabeprazole (AcipHex, AcidpHex Sprinkle)
  • Dexilant & Dexilant

PPI Interactions

Proton pumps have a number of drug interactions that may increase risks of side effects of certain medications. People who are taking OTC versions may be unaware of this increased risk.

One of the most notable drug interactions associated with PPI use involves an anti-platelet medication. Plavix (clopidogrel) is used to decrease the potential for blood clot formation, particularly in patients who are at increased heart attack or stroke. PPI medications may decrease the effectiveness of Plavix and in 2009, the FDA issued a warning about increased risk of taking omeprazole and clopidogrel together.

PPI Fracture Risk

In 2010, the FDA identified an increased risk of bone fractures in patients who take proton pump inhibitor medications due to decreased magnesium levels. The agency also determined that PPI use may increase the chance of other side effects such as severe diarrhea, cardiac events, birth defects, and vascular damage.

Labeling of prescription PPI medications was revised in 2011 with the addition of safety information about bone fractures, stating that higher doses and longer or more frequent use increased the risk. OTC medications are lower dosage and were not included in additional warnings.

PPI Kidney Side Effects Risk

PPI use has been shown to increase the risk of side effects related to kidney function and may result in sudden or long-term, permanent damage. In some cases, damage may be severe and even life-threatening.

Potential effects on the kidney may include:

  • Interstitial Nephritis – inflammation of the kidney
  • Chronic Kidney Disease (CKD) – long-term damage which results in loss of kidney function
  • Acute Renal Failure (ARF) – sudden and severe kidney damage also known as acute kidney injury
  • End Stage Renal Failure (ESRF) – the complete failure of the kidneys which may result in death

Damage to kidneys may be severe and permanent or life-threatening. In most cases, severe kidney events will require hospitalization and may necessitate kidney dialysis. If the damage is permanent, life-long dialysis may be required unless a transplant is performed.

Patients who experience renal failure may also develop complications due to the buildup of waste products in the blood. These effects may also be severe, permanent or life-threatening and include heart arrhythmia, heart failure and serious effects on lung function.

PPI Heart Attack

Two studies published in the medical journal PLOS-One in 2015, identified an increased risk of heart attack in people who took PPI medications. Researchers examined thousands of patient medical records and found that PPI use was associated with increased risk of cardiac events, even when the patients were otherwise healthy and did not have a prior history of heart disease. Longer term and higher dosages of PPI medications were associated with a greater risk.

PPI Other Effects

Pneumonia – Proton pump inhibitor use has also been associated with an increased risk of pneumonia. PPI medication’s action to lower stomach acid production may increase the ability for bacteria to grow in the upper GI. If stomach contents become aerosolized, bacteria may enter the lungs through inhalation and result in a respiratory infection which can become severe.

Diarrhea – PPI’s effects on the GI system may increase the chance of growth of a certain bacteria known as Clostridium difficile or “C diff”. This type of infection may cause severe diarrhea which may result in dehydration and electrolyte imbalance. If not treated adequately, C diff may become life-threatening.

Vascular Damage – In 2016, PPI use was associated with vascular damage which over time could contribute to conditions such as dementia. Premature aging of cells may also contribute to other conditions like heart attack and cancer, though a definitive link has not been established.

Birth Defects – Animal studies have shown that PPI use may be associated with certain cardiac birth defects and though no definitive studies have been performed in humans, PPI medications are generally listed as “Category C” and should not be used during pregnancy.

PPI Recall

Though concern about the safety of PPI medications has grown, no recall has been issued by the FDA or the manufacturers of any of the medications. As PPIs are available over-the-counter and taken without medical supervision, some professionals have expressed concern that the public may be unaware of the risks.

Other medications for treating conditions like heartburn are readily available and may be considered safer. These medications include the popular “H2 blockers” which are inexpensive and effective for many people.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.

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