After the Spanish Agency for Medicines and Other Health Products (AEMPS) published information that the use of omeprazole can cause nephritis and lead to kidney failure, the National Directorate of Pharmacy and Drugs of the Ministry of Health (Minsa) referred to the pharmacovigilance data of Omeprazole.
In its monthly safety bulletin, the AEMPS issued new information from the periodic evaluation of this product and in whose pharmacovigilance evaluation the appearance of acute tubulointerstitial nephritis (ITN) has been observed, which can appear at any time during treatment with omeprazole.
Several products with the active principle Omeprazole alone or in combination are currently registered in the National Directorate of Pharmacy and Drugs.
The Minsa authorities indicated that to date the National Pharmacovigilance Center (CNFV) has received few reports of suspected adverse reactions to drugs associated with the active ingredient omeprazole; however none associated with acute tubulointerstitial nephritis or acute renal failure.
“Acute tubulointerstitial nephritis can progress to kidney failure,” the AEMPS document specified.
TIN is an important cause of reversible acute renal failure (ARF). Between 6 and 25% of patients undergoing renal biopsy for AKI of unknown cause present it.
Omeprazole is a proton pump inhibitor drug that acts on the gastric parietal cell. It acts quickly and produces a control by means of the reversible inhibition of the acid secretion of the stomach with only a daily dose. Its use is indicated in reflux esophagitis, gastric ulcers, eradication of helicobacter pylori, gastric hypersection such as Zollinger-Ellison disease and in prophylaxis of gastric erosion by non-steroidal anti-inflammatory drugs.
