New safety updates about co-trimoxazole

The Russian Ministry of Health and the expert center of the Federal State Budgetary Institution "SCEEMP" published an information letter on the website of the State Register of Medicines (GRLS) about the need to make changes to the registration dossier documents for medicines that contain sulfamethoxazole and trimethoprim (co-trimoxazole).

Sulfamethoxazole in combination with trimethoprim has a bactericidal effect on a wide range of microorganisms, while the use of these substances separately from each other leads only to a bacteriostatic effect in in vitro experiments.

Co-trimoxazole is used to treat infections of the respiratory tract and ENT organs, genitourinary tract, gastrointestinal infections and some others.

In Russia, co-trimoxazole drugs are in public circulation in the form of tablets, suspensions for oral administration, and a concentrate for preparing a solution for infusion. 11 trade names of this combination manufactured in Russia and Poland are available on GRLS.

According to the letter, information about the risk of developing hemophagocytic lymphohistiocytosis (HLH) must be included in the Instructions for Medical Use (IMP), the Summary of product characteristics (SmPC) and the Patient information leaflet (PIL).

HLH is a life-threatening syndrome of pathological immune activation characterized by clinical signs and symptoms of excessive systemic inflammation (fever, swollen glands, feeling weak, dizziness, shortness of breath, bruising, skin rash). If a diagnosis of HLH is made, treatment with co-trimoxazole should be discontinued.

In Europe, recommendations from the Pharmacovigilance Risk Assessment Committee (PRAC) to update the SmPC and medicinal products related to the development of HLH appeared in May 2021.

It is interesting that in Europe there are no co-trimoxazole drugs registered under the mutual recognition procedure or a decentralized procedure, however, in some EU countries there is information about national registration of this combination, where the MAHs are the following companies ROCHE, ASPEN, BOUCHARA RECORDATI, T&D PHARMA GMBH, ALMIRALL, S.A.