Have You Had Complications After Taking PPIs?
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
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.
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.
- American Gastroenterological Association (02 July 2009), Acid-reducing Medicines May Lead To Dependency, Science Daily, Accessed on 03 August 02 July 2009
- Associated Press, 26 May 2010, New warning on heartburn drugs: bone fracture risk, Consumer Reports News, Accessed on 03 August 2017 26 May 2010
- DeNoon, D., (17 November 2009), FDA Warns Plavix Patients of Drug Interactions, WebMD Health News, Accessed on 03 August 2017 17 November 2009
- FDA Prescribing Information, (2017), Prevacid, Drugs.com, Accessed on 03 August 2017 2017
- Food and Drug Administration (02 March 2011), FDA Drug Safety Communication: Low magnesium levels can be associated with long-term use of Proton Pump Inhibitor drugs (PPIs), U.S. Food and Drug Administration, Accessed on 03 August 2017 02 March 2011
- Food and Drug Administration, (25 May 2010), For Consumers: Possible Increased Risk of Bone Fractures With Certain Antacid Drugs. U.S. Food and Drug Administration, Accessed on 03 August 2017 25 May 2010
- Lazarus, B., (February 2016), Proton Pump Inhibitor Use and the Risk of Chronic Kidney Disease, JAMA, Accessed on 03 August 2017 February 2016
- Leri, F., et al, (April 2013), Four-year trends of inappropriate proton pump inhibitor use after hospital discharge, Southern Medical Journal, Accessed on 03 August 2017 April 2013
- Norton, A., (10 June 2015), Popular Heartburn Meds Tied to Heart Attack Risk, HealthDay, Accessed on 03 August 2017 10 June 2015
- Perks, B., (16 June 2015), Proton pump inhibitors are associated with increased risk of heart attack, The Pharmaceutical Journal, Accessed on 03 August 2017 16 June 2015
- Richter, J., (2005), Review Article: The Management of Heartburn in Pregnancy, Alimentary Pharmacology & Therapeutics, Accessed on 03 August 2017 2005
- Splete, H., (01 December 2010), PPIs Might Raise Risk of Cardiac Birth Defects, Skin & Allergy News, Accessed on 03 August 2017 01 December 2010