The drug Veoza was approved in the EU a year ago, in December 2023. It is used to treat moderate to severe menopausal symptoms such as hot flashes and sweating.
– It is a completely different mechanism of action compared to hormone replacement drugs, says Karin Bolin, investigator at the Swedish Medicines Agency and one of Sweden’s representatives in PRAC, the European Medicines Agency EMA’s safety committee.
Relatively new drug
In the work leading up to the approval of the drug, the European Medicines Agency was able to demonstrate an increased risk of liver damage when using Veoza.
– Already during the clinical studies, elevated liver values were observed in two percent of the patients, but no serious cases were reported then, says Karin Bolin.
After approval, however, there have been reports of more serious liver damage.
– The cases we have seen have been isolated and have not led to permanent damage. When the treatment ended, liver function recovered, and no deaths or transplants have been reported, says Karin Bolin.
Already early warnings
For women prescribed Veoza, it is important to be aware of symptoms that may be signs of liver damage. It can be fatigue, itching, jaundice, dark urine, decreased appetite or abdominal pain. In the event of such symptoms, patients are advised to contact healthcare immediately.
– It is important that patients recognize these signs and seek care if they experience them, says Karin Bolin.
New guidelines for healthcare professionals
To minimize the risks, the PRAC has developed new recommendations. Liver function must be checked before starting treatment, every month during the first three months and then regularly according to the doctor’s judgment.
Healthcare professionals will be informed via updated product information and a safety information letter, which will be sent out in January. The information in the leaflet will also be revised to clarify the risk to patients.
In Sweden, Veoza has so far only been subsidized for patients where hormone therapy is not suitable.