EMA Reviews Safety of Doxycycline and Veoza, Issues New Recommendations
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recently concluded its review of several important safety signals, leading to relevant decisions regarding widely used medications. The meeting, held November 25-28, 2024, addressed ongoing concerns about the antibiotic doxycycline and provided crucial guidance for the safe use of fezolinetant (Veoza), a treatment for menopause symptoms.
Doxycycline and Suicide Risk: No Causal Link Confirmed
After a year-long review prompted by reports received from the Finnish authority and the European EudraVigilance database, the PRAC determined there is currently insufficient evidence to confirm a causal link between doxycycline use and suicide risk. While these reports outlined suspected cases of suicidal thoughts and actions, a thorough examination of data from spontaneous reports, medical literature, and real-world data via the DARWIN EU database did not support a clear connection. The Committee concluded that updates to product information are not necessary at this time, but monitoring of such events will continue through periodic safety update reports (PSURs).
Veoza (Fezolinetant): A Focus on Liver Safety
The PRAC reached significant conclusions regarding fezolinetant (Veoza), a drug indicated for hot flushes associated with menopause. The committee emphasized the risk of drug-induced liver injury (DILI) associated with Veoza and recommended close monitoring of liver function during treatment.
Several cases of significant elevations in liver enzymes (ALT and AST) associated with symptoms such as fatigue, pruritus, and jaundice have been reported. To mitigate these risks, the PRAC recommends liver function tests before initiating treatment, followed by monthly tests for the first three months and thereafter as clinically necessary. Patients experiencing suspicious symptoms should immediately discontinue treatment.
Communicating Safety Updates
Information regarding Veoza’s safety profile will be updated in the summary of product characteristics and package leaflet. An Important Information Note (NII) will also be disseminated to healthcare professionals to ensure safe and informed use of the medicine. Continuous monitoring of doxycycline will continue, while fezolinetant use will be subject to new liver function monitoring protocols.
Are there any age groups that need to be more careful about taking doxycycline?
## Interview: Doxycycline Safety and New EMA Recommendations
**News Anchor:** Welcome back to HealthWatch. We’re joined today by Dr. Sarah Jones, a specialist in infectious diseases, to discuss recent news from the European Medicines Agency regarding doxycycline, a commonly prescribed antibiotic. Dr. Jones, thanks for joining us.
**Dr. Jones:** It’s my pleasure.
**News Anchor:** The EMA has just concluded a review of doxycycline’s safety profile. Can you shed some light on their findings?
**Dr. Jones:** Absolutely. The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) conducted a year-long review prompted by reports suggesting a potential link between doxycycline and an increased risk of suicide. However, after careful analysis of available data, the PRAC concluded that **no causal link has been confirmed [[1]](https://medlineplus.gov/druginfo/meds/a682063.html)
**. This is positive news for patients who rely on doxycycline for various infections.
**News Anchor:** That’s reassuring. Are there any specific age groups that need to be particularly cautious when taking doxycycline?
**Dr. Jones:** The EMA emphasizes the importance of careful use, especially in children under 8 years old. While it can be used in young children for specific serious conditions like inhalational anthrax or Rocky Mountain spotted fever, it should generally be avoided in this age group.
**News Anchor:** It seems responsible use and open communication with a doctor are key.
**Dr. Jones:** Absolutely. As with any medication, potential risks and benefits need to be weighed carefully, and patients should always discuss any concerns with their healthcare provider.
**News Anchor:** Thank you for sharing your expertise, Dr. Jones. This information will be helpful for our viewers.
