Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) – 01-04 September 2025:

Levamisolo

• Safety issue: Risk of leukoencephalopathy and e demyelination in the central nervous system; serious cases of leukoencephalopathy following levamisole use reported, one of which resulted in death.
• Communications and recommendations: PRAC starts safety review and will issue a recommendation on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the EU. No medicinal products for human use authorized in Italy.

Caspofungin 

• Safety issue: New warning against use of PAN-based membranes during continuous renal replacement therapy. Antifungal treatment failure may lead to worsening of the systemic fungal infection, which may be fatal in these critically ill patients.
• Communications and recommendations: If PAN-derived membranes are being used, healthcare professionals should either switch to an alternative membrane or consider an alternative antifungal medicine. A Direct Healthcare Professional Communication (DHPC) will be sent to healthcare professionals. (NIIS - DHPC).

Crysvita (burosumab)

• Safety issue: Risk of severe hypercalcaemia (in particular in patients with tertiary hyperparathyroidism.
• Communications and recommendations: Blood calcium levels and PTH should be closely monitored. The Product Information for Crysvita will be updated and a Direct Healthcare Professional Communication (DHPC) will be sent to healthcare professionals (NIIS - DHPC). 

Remsima (infliximab)

• Safety issue: Risk of severe and potentially life-threatening adverse reactions in people with hereditary fructose intolerance (HFI) as it contains sorbitol. 
• Communications and recommendations: Before starting treatment with the new Remsima concentrate for solution for infusion, healthcare professionals must confirm that the patient does not have hereditary fructose intolerance. The Product Information and patient reminder card for Remsima will be updated to reflect this new information.

Tegretol (carbamazepina)

• Safety issue: Risk of serious adverse reactions (metabolic acidosis renal acute renal failure and liver dysfunction) in neonates due to the presence of propylene glycol excipient which exceeds the recommended threshold for neonates.
• Communications and recommendations:  Restricted use in neonates  (below 4 weeks of age for term babies, or 44 weeks post-menstrual age for pre-term babies) unless there is no other treatment option available.  The product information of Tegretol 100 mg/5 mL is being updated and a Direct Healthcare Professional Communication (DHPC) will be sent to healthcare professionals. (NIIS - DHPC). 

Published on: 05 September 2025