The rates of common adverse events reported during treatment with proton pump inhibitors used in general practice in England: cohort studies

Abstract

Aims To estimate the rates of common adverse events in patients treated with the proton pump inhibitors omeprazole, lansoprazole and pantoprazole in general practice in England. Methods In prescription‐event monitoring cohort studies, data on dispensed prescriptions prescribed by general practitioners in England soon after each drug was launched were linked to subsequent clinical events recorded by the prescriber. 16 205 patients prescribed omeprazole between June 1989 and June 1990, 17 329 patients prescribed lansoprazole between May and November 1994, and 11 541 patients prescribed pantoprazole between December 1996 and June 1997 were studied. Results The commonest adverse events in the omeprazole, lansoprazole and pantoprazole cohorts were diarrhoea (incidence: 0.18, 0.39 and 0.23 per 1000 days of exposure, respectively); nausea/vomiting (incidence: 0.16, 0.22 and 0.18 per 1000 days of exposure, respectively); abdominal pain (incidence: 0.17, 0.21 and 0.17 per 1000 days of exposure, respectively); and headache (incidence rates: 0.10, 0.17 and 0.15 per 1000 days of exposure, respectively). The remaining adverse events occurred at rates of less than 0.11 per 1000 days of exposure. There were little absolute differences in the rates of most events between the three proton pump inhibitors. However, diarrhoea was more commonly associated with lansoprazole compared with omeprazole (rate difference: 0.21 per 1000 days of exposure; 95% CI 0.17, 0.25; rate ratio: 2.11; 1.78, 2.51), and there was a clear age‐response relationship. Conclusions Adverse events occurred relatively infrequently in all three cohorts. There were only small absolute differences in event rates between the three drugs, although these data suggest the hypothesis that lansoprazole is associated with more frequent occurrence of diarrhoea, particularly in the elderly.

A summary of Food and Drug Administration‐reported adverse events and drug interactions occurring during therapy with omeprazole, lansoprazole and pantoprazole

“…This confirms the experience of controlled clinical trials and previous adverse event studies which shows that proton pump inhibitors are safe and can be used without safety concerns regarding their potential for interaction. 7,13 We concentrated in particular on vitamin K antagonist interactions, as these are reported more frequently than all other interactions combined and are also important from a theoretical perspective.…”

“…In spite of their excellent safety record, the relative safety of different proton pump inhibitors has been widely publicized over the last few years, with particular emphasis on drug-drug interactions. [1][2][3][4][5][6][7][8][9] It has been suggested that pantoprazole is less likely than omeprazole or lansoprazole to interact with other drugs as a result of minor differences in its metabolic profile. 10,11 In a recent retrospective survey of patient treatment records from US veterans, it was concluded that the co-prescription of omeprazole or lansoprazole with warfarin, clarithromycin or diclofenac led to an increase in adverse events, requirements for care and total costs of care.…”

Suboptimal use of gastroprotective medication in elderly antiplatelet users

“…However, overall incidence of adverse effects mentioned above remains very low. In general PPIs as well as H 2 -antagonists represent drug classes with favorable safety profi le (36).…”

Effets indésirables des inhibiteurs de la pompe à proton : faut-il craindre de les prescrire au long cours ?

“…Ils touchent moins de 5 % des patients traités par IPP et disparaissent rapidement à l'arrêt du traitement [3].…”