Based on the results of monitoring information published on the official EMA website, in particular PRAC recommendations on the safety of medicinal products for December 2025, the Center recommends that marketing authorization holders make the relevant changes to the instructions for medical use of medicinal products containing the following active substances:
Azithromycin (azithromycin)
Remove the indications for use from the instruction due to an unfavourable benefit/risk ratio for the following indications: moderate acne vulgaris, Helicobacter pylori eradication and prevention of exacerbations of eosinophilic and non-eosinophilic asthma.
Include in the instruction a warning about the risk of developing antimicrobial resistance and the need to prescribe azithromycin only after assessing the benefit/risk ratio, taking into account the local prevalence of resistance, as well as in cases where the use of priority treatment regimens is inappropriate or impossible.
More details at the link https://surl.li/krqzni
Bosutinib (bosutinib)
Add cutaneous vasculitis as an adverse reaction with frequency "uncommon".
More details at the link https://surl.li/rokpgk
Testosterone (testosterone)
For oil-based solutions, add pulmonary microembolism as an adverse reaction with the frequency "rare" and interaction with sodium-dependent glucose cotransporter 2 type inhibitors (SGLT2) and increased haemoglobin and haematocrit levels.
More details at the link https://surl.lu/lnlrdq
Bupropion (bupropion)
Amend the hypersensitivity warning and add a warning regarding severe cutaneous adverse reactions (SCARs). Also add toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS) as adverse reactions with the frequency "unknown".
More details at the link https://surl.li/bvtvxy
Botulinum toxin type A (botulinum toxin a)
Add a warning about reported cases of iatrogenic botulism, as well as about the measures to be taken if signs or symptoms suggestive of the spread of botulinum toxin effect appear.
Amend the existing warning on measures in case of overdose to include information on treatment in cases where spread of the toxin effect is suspected.
More details at the link https://surl.li/ycrgzx
Caspofungin (caspofungin)
Amend the use of caspofungin during renal replacement therapy (RRT). In patients receiving caspofungin during continuous RRT, the use of membranes made on the basis of polyacrylonitrile may lead to adsorption of the medicinal product, potentially reducing the efficacy of caspofungin.
It is recommended to use an alternative extracorporeal membrane or another antifungal medicinal product. The risk of lack of treatment efficacy may lead to progression of the infection and a fatal outcome.
More details at the link https://surl.li/yamrev
Botulinum neurotoxin A (150 kD), free from complexing proteins (botulinum neurotoxin type a (150 kd) free from complexing proteins)
Add a warning that cases of iatrogenic botulism have been reported, as well as the measures to be taken in case of the appearance of signs or symptoms indicating the spread of the botulinum toxin effect.
Amend the warning on measures in case of overdose to include information on treatment in cases where spread of the toxin effect is suspected.
More details at the link https://surl.li/hvxvtu
Disodium hydrogen phosphate / sodium dihydrogen phosphate, phosphate sodium (disodium hydrogen phosphate / sodium dihydrogen phosphate, phosphate sodium)
Add a warning about the risk of increased sodium and phosphate levels in the blood and decreased calcium and potassium levels, which may lead to the development of hypernatremia, hyperphosphatemia, hypocalcemia and hypokalemia, which may be accompanied by clinical manifestations, in particular tetany and renal failure.
Add metabolic and nutritional disorders: hyperphosphatemia, hypokalemia, hypernatremia, hypocalcemia and tissue calcification as adverse reactions with a frequency of "rare".
More details at the link https://surl.li/cxgrww
The benefit/risk ratio of medicinal products remains unchanged provided the proposed changes to the instructions for medical use are made.
#pharmacovigilance #MedicinalProductSafety #Instructions #EMA #PRAC #SEC
