In October 2025, the Slovenian Agency for Medicinal Products and Medical Devices (JAZMP) published the latest release of its electronic bulletin, which includes current drug safety topics and important updates on drug information.

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

Finasteride and dutasteride: suicide risk mitigation
PRAC confirmed suicidal thoughts as an adverse effect of 1- and 5-mg finasteride tablets. Benefits of finasteride and dutasteride still outweigh risks for all approved indications. Frequency of this effect is unknown.

Ixchiq Vaccine: safety review started
PRAC initiated a safety review of Ixchiq (live attenuated chikungunya vaccine) following reports of serious adverse events in older adults.

Semaglutide: NAION very rare adverse effect
Treatment with semaglutide should be stopped if NAION occurs. PRAC concluded NAION is a very rare risk associated with semaglutide.

Varicella Vaccines: encephalitis risk review
PRAC started a review of known encephalitis risk for Varilrix and Varivax after a fatal case post-vaccination.

Clozapine: updated blood monitoring recommendations
PRAC agreed on direct communication to healthcare professionals regarding revised blood monitoring due to risk of severe neutropenia and agranulocytosis.

Furthermore it contained an article about use of Medicines During Pregnancy and Adverse Event Reporting. Medication use during pregnancy is common, for both acute and chronic conditions, including those that may worsen or require ongoing treatment during pregnancy. Pregnant and breastfeeding women are largely excluded from clinical trials: less than 0.4% of trials in the EU include pregnant women, and only 0.1% include breastfeeding women. As a result, product information often lacks details on the benefits and risks during pregnancy and breastfeeding, making informed treatment decisions difficult for healthcare professionals and patients. This is the reason why reporting adverse events is extremely important.

If a suspected adverse effect involves the embryo/fetus or child, it is considered a parent-child report, which requires the collection of more specific information: suspect drug, data on mother, such as date of birth, pre-pregnancy weight, use of folic acid before and during pregnancy, lifestyle factors (smoking, alcohol, substance/drug abuse), previous pregnancies and outcomes, including prior miscarriages or ectopic pregnancies, history of chronic and acute illnesses, medication use before pregnancy, data on father, pregnancy, birth, child, brestfeeding,

Adverse event reports play a crucial role in ensuring the safe use of medicines, especially for vulnerable populations such as pregnant and breastfeeding women.

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.