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

Labenz, Joachim; Petersen, Karl‐Uwe; Rösch, Wolfgang; Koelz, H. R.

doi:10.1046/j.1365-2036.2003.01550.x

Cited by 69 publications

(38 citation statements)

References 22 publications

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“…Extending the analyses for reasons of comparison, pantoprazole, like omeprazole, was not associated with a significant increased risk of bleeding (RR 2.8; 95% CI 0.4-19.7). Our finding that the results were similar for all PPIs is in line with a recent evaluation of the Food and Drug Administration's database of reported adverse events and drug interactions [10], and disagrees with previous suggestions that omeprazole [19] or omeprazole and lansoprazole [14] bear a higher risk of interactions than pantoprazole.…”

Section: Discussioncontrasting

confidence: 64%

Main comedications associated with major bleeding during anticoagulant therapy with coumarins

Beest

Erkens

Petersen

et al. 2005

Eur J Clin Pharmacol

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Objective: To study the main comedications associated with major bleeding during anticoagulant therapy with coumarins in a non-selected population under everyday circumstances. Methods: The study population for this retrospective cohort study included all new users of phenprocoumon or acenocoumarol aged 40-80 years, during the period 1992-2000 in the PHARMO Record Linkage System. All patients were followed until the last dispensing of phenprocoumon or acenocoumarol, the first bleeding complication requiring hospitalization, death, or the end of the study period. The number of days on coumarins alone and the number of days on coumarins in combination with several potentially interactive drugs during follow-up were determined for each patient. Results: The inclusion criteria of this study were met by 19,935 new users of phenprocoumon or acenocoumarol. During follow-up, 552 patients were hospitalized for bleeding. Of all potentially interactive drugs started during anticoagulant therapy by at least 50 patients and with at least five bleedings, antibacterial drugs were associated with a four to seven times increased risk of bleeding. Among non-steroidal anti-inflammatory drugs, naproxen had the highest relative risk. Antithrombotic salicylates and tramadol were associated with a three times increased risk of bleeding. Conclusion: Antibacterial drugs, non-steroidal antiinflammatory drugs, antithrombotic salicylates and tramadol were the main potentially interactive drugs associated with major bleeding during anticoagulant therapy with coumarins under everyday circumstances.

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Section: Discussioncontrasting

confidence: 64%

Main comedications associated with major bleeding during anticoagulant therapy with coumarins

Beest

Erkens

Petersen

et al. 2005

Eur J Clin Pharmacol

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“…Recently, we are facing the side effects of long-term PPI therapy, such as Clostridium difficile colitis, community-acquired pneumonia, osteoporosis, iron and vitamin deficiencies, as well as the increase of food allergies [45][46][47][48][49]. The interaction caused by PPIs on the cytochrome enzymes hazard appropriate drug actions of clopidogrel, vitamin K antagonists, and benzodiazepines [50,51]. All these raised the question whether the less expensive H2RAs are suitable to prevent aspirin-induced GI bleeding.…”

Section: Discussionmentioning

confidence: 99%

PPIs Prevent Aspirin-Induced Gastrointestinal Bleeding Better than H2RAs. A Systematic Review and Meta-analysis

Szabó¹,

Mátics

Hegyi

et al. 2017

JGLD

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Background & Aims: Aspirin is one of the most widely used medication for its analgesic and anti-platelet properties and thus a major cause for gastrointestinal (GI) bleeding. This study compared the preventive effect of histamine-2 receptor antagonists (H2RAs) and proton-pump inhibitors (PPIs) against chronic low-dose aspirin (LDA)-related GI bleeding and ulcer formation.Methods: Electronic databases of Pubmed, Embase and Cochrane Central Register of Controlled Trials were searched for human observations (randomised controlled trials and observational studies) comparing the long term effects of PPIs and H2RAs treatment in the prevention of GI bleeding or ulcer formation in patients on chronic LDA treatment listed up till September 30, 2016. Two independent authors searched databases using PICO questions (aspirin, H2RA, PPI, GI bleeding or ulcer), and reviewed abstracts and articles for comprehensive studies keeping adequate study quality. Data of weighted odds ratios were statistically evaluated using Comprehensive Metaanalysis (Biostat, Inc., Engelwood, MJ, USA), potential bias was checked.Results: Nine studies for GI bleeding and eight studies for ulcer formation were found meeting inclusion criteria, altogether 1,879 patients were included into review. The H2RAs prevented less effectively LDA-related GI bleeding (OR= 2.102, 95% CI: 1.008-4.385, p<0.048) and ulcer formation (OR= 2.257, 95% CI: 1.277-3.989, p<0.005) than PPIs.Conclusion: The meta-analysis showed that H2RAs were less effective in the prevention of LDA-related GI bleeding and ulcer formation suggesting the preferable usage of PPIs in case of tolerance.Abbreviations: COX -1: cyclooxygenase-I enzyme; COX-2: cyclooxygenase-II enzyme; GI: gastrointestinal; H2RA(s): histamine-2 receptor antagonist(s); H. pylori: Helicobacter pylori; LDA: low dose aspirin; NSAID(s): non-steroid anti-inflammatory drug(s); OR: Odds ratio; PPI(s): proton-pump inhibitor(s); RCT: randomized controlled trial; RR: relative risk; UGIB: upper gastrointestinal bleeding.

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“…The frequency of the most common side effects is only somewhat higher compared with placebo and does not exceed 6%. [37][38][39] Headache, the most frequent complaint in clinical trials, is declared by up to 5.5% of the subjects, and serious adverse reactions, for example, hepatitis (lansoprazole, omeprazole), interstitial nephritis (omeprazole), or visual disturbances, usually PPI overutilization in outpatients often occurs in the case of failure to reevaluate the need for continuous therapy in previously hospitalized individuals discharged on a PPI or when the step-down or on-demand therapeutic strategy is not adopted in practice. It is also a common practice to prescribe PPIs by general practitioners as symptomatic treatment without clear diagnosis or for unlicensed indications.…”

mentioning

confidence: 99%

“…As many as 44% of the PPI group reported acid-related symptoms in following quick intravenous infusion (omeprazole, pantoprazole) are rarely reported. 38,39 The current and short-term use (<30 days) of PPIs, particularly at high doses, was associated with community-acquired pneumonia 40,41 ; however, these associations may be confounded. 42,43 A prophylactic administration of PPIs in new users of NSAIDs does not increase the risk of hospitalization for community--acquired pneumonia.…”

mentioning

confidence: 99%

See 1 more Smart Citation

Overuse of proton pump inhibitors

Ksiądzyna¹,

Szeląg²,

Paradowski³

2015

Polish Archives of Internal Medicine

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

Cited by 69 publications

References 22 publications

Main comedications associated with major bleeding during anticoagulant therapy with coumarins

Main comedications associated with major bleeding during anticoagulant therapy with coumarins

PPIs Prevent Aspirin-Induced Gastrointestinal Bleeding Better than H2RAs. A Systematic Review and Meta-analysis

Overuse of proton pump inhibitors

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