New side effects of antiulcer drugs.

In May 2023, a letter regarding the safety of proton pump inhibitor drugs containing omeprazole, pantoprazole, rabeprazole, lansoprazole, esomeprazole, dexlansoprazole as an active ingredient was published on the website of the State Drug Administration of the Ministry of Health of the Russian Federation. It turned out that drugs of this group can cause kidney disease.

  1. What are these active ingredients?

-Azoles – are a group of compounds capable of blocking the formation of hydrochloric acid in the gastrointestinal tract, and, as a result, reduce acidity. Indications for the use of these substances are gastric and duodenal ulcers, dyspepsia associated with high acidity and other acid-dependent diseases.

  1. How instructions for medical use / summary of product characteristics / package leaflet must be updated?

According to a letter from the expert center of the Ministry of Health of the Russian Federation, documents intended for medical workers and patients (Side Effects section) must include information about the risk of developing acute tubulointerstitial nephritis (TIN) with possible progression to renal failure.

Tubulointerstitial nephritis is a primary lesion of the renal tubules and interstitium, leading to decreased renal function. The occurrence of this disease is due to the body’s immune response to the active substance or its metabolites.

This side effect was first described by Ruffenach et al. In 1992. Since then, information about this event has come from many national adverse event registries.

  1. Who must update these documents?

The letter of the expert center refers to 6 international non-proprietary names (INN). Only for the INN of omeprazole, more than 80 valid RCs for drugs are found in the GRLS, and for the INN of pantoprazole, more than 20. Marketing authorization holders will have to do a lot of work.