Pantoprazole warnings
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Pantoprazole Warnings: Key Insights from Recent Research
Pantoprazole and Cisplatin-Related Toxicity
Lack of Efficacy in Reducing Cisplatin Toxicity
Pantoprazole, an inhibitor of the organic cation transporter 2 (OCT2), was investigated for its potential to reduce cisplatin-related ototoxicity and nephrotoxicity in children and adolescents with osteosarcoma. The study found that pantoprazole did not ameliorate cisplatin-associated nephrotoxicity or ototoxicity. Patients reported tinnitus and subjective hearing loss, and biomarkers indicated no significant protective effect from pantoprazole on renal or auditory functions1.
Pantoprazole in ICU Patients
Mortality and Clinically Important Events
A large multicenter trial assessed the use of pantoprazole for gastrointestinal bleeding prophylaxis in ICU patients. The study concluded that there was no significant difference in 90-day mortality between patients receiving pantoprazole and those receiving a placebo. Additionally, the incidence of clinically important events, including gastrointestinal bleeding, pneumonia, Clostridium difficile infection, and myocardial ischemia, was similar between the two groups. This suggests that pantoprazole does not significantly impact overall mortality or the occurrence of major adverse events in this patient population2.
Pharmacokinetic Interactions
Interaction with Diazepam
A study on the pharmacokinetic interaction between pantoprazole and diazepam found that pantoprazole does not significantly affect the clearance or elimination half-life of diazepam. This indicates that pantoprazole can be co-administered with diazepam without the need for dose adjustments, even at high doses of pantoprazole3.
Postmarketing Surveillance
Adverse Drug Reactions
Postmarketing surveillance of pantoprazole in general practice revealed that the most common adverse event leading to discontinuation was diarrhea. Other adverse drug reactions were reported but were consistent with the known safety profile of pantoprazole. The study confirmed that pantoprazole is generally well-tolerated, with a safety profile similar to other proton pump inhibitors4.
Conclusion
Pantoprazole is generally safe and well-tolerated, with a known safety profile that includes common adverse events such as diarrhea. However, it does not provide significant protection against cisplatin-related nephrotoxicity or ototoxicity in pediatric cancer patients and does not significantly impact mortality or major adverse events in ICU patients. Additionally, pantoprazole does not interact significantly with diazepam, allowing for concurrent administration without dose adjustments.
Sources and full results
Most relevant research papers on this topic
Pantoprazole, an Inhibitor of the Organic Cation Transporter 2, Does Not Ameliorate Cisplatin‐Related Ototoxicity or Nephrotoxicity in Children and Adolescents with Newly Diagnosed Osteosarcoma Treated with Methotrexate, Doxorubicin, and Cisplatin
Pantoprazole, an inhibitor of organic cation transporter 2, did not improve cisplatin-related ototoxicity or nephrotoxicity in children and adolescents with osteosarcoma treated with methotrexate, doxorubicin, and cisplatin.
RCTPantoprazole in Patients at Risk for Gastrointestinal Bleeding in the ICU
Pantoprazole and placebo show similar mortality rates and clinically important events in adult ICU patients at risk for gastrointestinal bleeding.
RCT
Large Human Trial
Rigorous Journal
Highly CitedLack of pharmacokinetic interaction of pantoprazole with diazepam in man.
Pantoprazole and diazepam may be administered concomitantly without dose adjustment, even when high doses of pantoprazole are required.
RCTThe Pharmacovigilance of Pantoprazole
Pantoprazole is an effective and well-reported proton pump inhibitor in general practice in England, with common adverse events including diarrhoea.
Observational StudyHeterogeneity of treatment effect of prophylactic pantoprazole in adult ICU patients: a post hoc analysis of the SUP-ICU trial
Prophylactic pantoprazole may increase the risk of serious adverse events in patients with greater illness severity or more risk factors for gastrointestinal bleeding.
Rigorous JournalPantoprazole
Pantoprazole is an effective agent for managing acid-related disorders, with similar efficacy to other PPIs and greater efficacy than histamine H(2)-antagonists.
Non-RCTHighly CitedEfficacy and Safety of Pantoprazole Delayed-release Granules for Oral Suspension in a Placebo-controlled Treatment-withdrawal Study in Infants 1–11 Months Old With Symptomatic GERD
Pantoprazole significantly improved GERD symptom scores in infants and was well-tolerated, but during the randomized, double-blind, placebo-controlled treatment phase, no significant differences were found in withdrawal rates due to lack of efficacy.
RCT
Very Rigorous JournalHighly CitedPantoprazole to Prevents Gastroduodenal Events in Patients Receiving Rivaroxaban and/or Aspirin in a Randomized, Double-blind, Placebo-controlled Trial.
Pantoprazole reduces bleeding from gastroduodenal lesions in patients receiving low-dose anticoagulation and/or aspirin for stable cardiovascular disease, but does not significantly reduce upper gastrointestinal events.
RCTLarge Human TrialHighly CitedNo evidence of harm with long-term pantoprazole?
Long-term pantoprazole use is not associated with significant adverse events, except for a potential increased risk of enteric infections.
RCTPantoprazole or Placebo for Stress Ulcer Prophylaxis (POP-UP): Randomized Double-Blind Exploratory Study*
Pantoprazole prophylaxis in mechanically ventilated critically ill patients does not show evidence of benefit or harm, warranting further evaluation.
RCTHighly Cited