Recent Safety Data: Implications for Use of Proton Pump Inhibitors

DECEMBER 21, 2016
Supported by an unrestricted grant from P&G.

Heartburn is a common symptom; in North America, heartburn is experienced at least once per week by an estimated 18% to 28% of adults.1 A variety of OTC treatment options are available for heartburn management, including proton pump inhibitors (PPIs), which have a well-studied safety profile that has been verified in multiple randomized controlled trials, as well as decades of clinical experience.2-4 Very small theoretical risks with PPIs have been identified in observational studies of patients receiving therapy over months to years5-11; these studies do not apply to short-term treatment, as is recommended with OTC use.
Pharmacy Times® has made available a review of practical information regarding recent safety data on PPIs, to assist pharmacists in educating their patients and providing guidance regarding appropriate product use.
  1. El-Serag HB, Sweet S, Winchester CC, Dent J. Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2014;63(6):871-880. doi: 10.1136/gutjnl-2012-304269.
  2. Chapman DB, Rees CJ, Lippert D, Sataloff RT, Wright SC Jr. Adverse effects of long-term proton pump inhibitor use: a review for the otolaryngologist. J Voice. 2011;25(2):236-240. doi: 10.1016/j.jvoice.2009.10.015.
  3. Davies M, Wilton LV, Shakir SA. Safety profile of esomeprazole: results of a prescription-event monitoring study of 11 595 patients in England. Drug Saf. 2008;31(4):313-323.
  4. Klinkenberg-Knol EC, Nelis F, Dent J, et al; Long-Term Study Group. Long-term omeprazole treatment in resistant gastroesophageal reflux disease: efficacy, safety, and influence on gastric mucosa. Gastroenterology. 2000;118(4):661-669.
  5. Arora P, Gupta A, Golzy M, Patel N, et al. Proton pump inhibitors are associated with increased risk of development of chronic kidney disease. BMC Nephrol. 2016;17(1):112. doi: 10.1186/s12882-016-0325-4.
  6. Haenisch B, von Holt K, Wiese B, et al. Risk of dementia in elderly patients with the use of proton pump inhibitors. Eur Arch Psychiatry Clin Neurosci. 2015;265(5):419-428. doi: 10.1007/s00406-014-0554-0.
  7. Gomm W, von Holt K, Thomé F, et al. Association of proton pump inhibitors with risk of dementia: a pharmacoepidemiological claims data analysis. JAMA Neurol. 2016;73(4):410-416. doi: 10.1001/jamaneurol.2015.4791.
  8. Atri A, Gerson LB. Continued questions about whether avoidance of proton pump inhibitors can reduce risk of dementia. Gastroenterology. 2016;151(3):555-558. doi: 10.1053/j.gastro.2016.07.028.
  9. Wijarnpreecha K, Thongprayoon C, Panjawatanan P, Ungprasert P. Proton pump inhibitors and risk of dementia. Ann Transl Med. 2016;4(12):240. doi: 10.21037/atm.2016.06.14.
  10. Xie Y, Bowe B, Li T, Xian H, Balasubramanian S, Al-Aly Z. Proton pump inhibitors and risk of incident CKD and progression to ESRD. J Am Soc Nephrol. 2016;27(10):3153-3163.
  11. Lazarus B, Chen Y, Wilson FP, et al. Proton pump inhibitor use and the risk of chronic kidney disease. JAMA Intern Med. 2016;176(2):238-246. doi: 10.1001/jamainternmed.2015.7193.


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