In July 2025, the Slovenian Agency for Medicinal Products and Medical Devices (JAZMP) released a new version of the electronic bulletin, which includes current drug safety topics and important updates on drug information, with the aim of informing healthcare professionals about all significant new developments. 

The latest version of the bulletin, covered the following highlights from the PRAC meetings: 

MAY 
–  Finasteride and Dutasteride:  Measures to reduce the risk of suicidal thoughts.  

Following a review of available data on medicines containing finasteride and dutasteride at the EU level, the PRAC confirmed suicidal ideation as an adverse reaction for both 1 mg and 5 mg finasteride tablets. However, the Committee concluded that the benefits of finasteride- and dutasteride-containing medicines continue to outweigh their risks in all approved indications. The frequency of this adverse reaction is unknown, meaning it cannot be estimated from the available data. 
 

–  Ixchiq vaccine: Start of safety review. 

 Following reports of serious adverse events in older adults, the PRAC has initiated a safety review of the Ixchiq vaccine (a live attenuated vaccine against the chikungunya virus). 
 

JUNE 
–  Semaglutide: non-arteritic anterior ischemic optic neuropathy (NAION)  confirmed as a very rare adverse reaction. Treatment with semaglutide should be discontinued if NAION occurs. 
 

–  Varicella vaccines: Review of known risk of encephalitis.  

Following a report of a fatal outcome after vaccination with Varilrix, the PRAC has initiated a review of the known risk of encephalitis (inflammation of the brain) associated with two varicella (chickenpox) vaccines, Varilrix and Varivax. 

JULY 
– Ixchiq vaccine: Temporary vaccination restriction in the elderly lifted.  

The vaccine should only be used when there is a significant risk of chikungunya infection and after careful consideration of the benefits and risks. 

 
– Varicella vaccines: Review of encephalitis risk concluded. 

 After careful evaluation of available data from clinical trials, scientific literature, and post-marketing exposure, the Committee recommended updating the information on the Varilrix and Varivax vaccines with a more detailed description of the severity of the risk of encephalitis. Both vaccines remain contraindicated in immunocompromised individuals, and no additional risk minimization measures are required. 
 
– Valproate: New data on risk in males.  

The PRAC is assessing new data on the potential risk of neurodevelopmental disorders (NDD) in children fathered by men treated with valproate, levetiracetam, or lamotrigine in the three months prior to conception, based on a recent study involving several data registries in Denmark. 
 

– Clozapine: Revised recommendations for routine blood monitoring.  

The PRAC agreed on a Direct Healthcare Professional Communication (DHPC) regarding the revised recommendations for blood monitoring due to the risk of severe neutropenia and agranulocytosis associated with the use of clozapine. 

The latest version of the bulletin, covered also:  

• changes in Product information for several NP/MRP/DCP medicines (from March 2025 to July 2025),
• changes in Product  information for several CP medicines (from  February 2025 to April 2025), 
• direct healthcare professional communications, published on the JAZMP website between  April 2025  and July 2025,
• new and updated (or withdrawn) educational materials, part of additional risk-reduction measures approved between May 2025 and July 2025.

In June this year, the EMA published new guidelines (ICH E21 Guideline on inclusion of pregnant and breastfeeding individuals in clinical trials) for public consultation, which will run until September 2025. These guidelines contain recommendations on how to include (or retain) pregnant and breastfeeding individuals in clinical trials. The goal is to ensure that medicine developers obtain the most reliable clinical data in this population, enabling more informed treatment decisions. 

A significant amount of useful data is also being collected within the ConcePTION project, a public-private initiative operating since 2019 that connects 88 organizations from 22 countries, aiming to improve the way data on medication use during pregnancy and breastfeeding are collected and accessed. 

Slovenian Agency for Medicinal Products and Medical Devices (JAZMP) also published an invitation to MEDSAFETYWEEK 2025 (10th International Medication Safety Awareness Week), from 3. – 9. November 2025. 
  

This year’s theme: 
Everyone can contribute to safer use of medicines 

Pharmacovigilance Bulletin is available on the JAZMP website, and it is free of charge. Healthcare professionals can also subscribe to the Pharmacovigilance Bulletin and receive the newsletter directly to their e-mail.