Doxycycline: currently available evidence does not support an association with suicidal risk
The EMA safety committee (PRAC) has concluded that the currently available evidence is insufficient to demonstrate a causal relationship between the use of the antibiotic doxycycline and the risk of suicide.
Doxycycline is a broad-spectrum antibiotic widely used to treat a variety of bacterial infections, including acne, urinary tract and lower respiratory tract infections, dental infections, and skin infections. It is also used to prevent the development of certain infections such as malaria.
A safety signal about the risk of suicide, suicidal thoughts or actions with doxycycline was raised on the basis of cases reported to the Finnish competent authority, EudraVigilance, a centralized European database of suspected side effect reports, and cases reported to the medical authority. literature.
The PRAC started the review in November 2023 and asked doxycycline marketing authorization holders to carry out a cumulative review of data from all relevant sources.
PRAC also requested evidence-based research through DARWIN EU, including data from electronic health records and disease registries, to facilitate signal assessment. After reviewing all the evidence from spontaneous reports, the literature, discussion of possible mechanisms and the study conducted through DARWIN EU, the PRAC considered that the evidence is insufficient to establish a causal relationship and that the product information for doxycycline has not been updated. justified.
Suicide events associated with doxycycline are closely monitored, and any new evidence is discussed in Periodic Safety Update Reports (PSURs).
New safety information for healthcare professionals
Veoza (fezolinentant): new recommendations to minimize the risk of liver injury
The PRAC has agreed to a direct healthcare professional (DHPC) communication about the risk of drug-induced liver injury (DILI) with Veoza (fezolintant) and has recommended monitoring of liver function before and during treatment.
Veoza is a medicine used to treat moderate to severe vasomotor symptoms (also called hot flashes or night sweats) associated with menopause.
The committee considered an assessment of the potential risk of fetozolinetan to cause drug-induced liver injury based on information from all available sources, including reports of suspected side effects and studies published in the scientific literature.
Elevations of the liver enzymes alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) (>10x upper limit of normal) and concomitant elevations of bilirubin and/or alkaline phosphatase (ALP) have been reported in post-marketing women using Veoza. In some cases, elevated liver function tests (LFTs) were associated with signs or symptoms of liver damage, such as fatigue, itching, jaundice, dark urine, decreased appetite, or abdominal pain.
The PRAC recommends that LFT tests should be performed before starting treatment. During the first 3 months of treatment, monthly LFT tests should be performed and thereafter based on clinical judgment. During treatment, LFT tests must be performed if symptoms suggestive of liver damage occur. Liver function must be monitored until they have normalized.
Treatment should be interrupted in certain cases where transaminase and bilirubin values ​​increase or if the increase in liver enzyme values ​​is accompanied by symptoms suggestive of liver damage.
Veoza’s Summary of Product Characteristics and Package Leaflet are updated to reflect new risk information and recommendations.
Once Veoza’s DHPC has been approved, MAHs will distribute it to healthcare professionals according to an agreed communication plan and publish it Direct contact with healthcare professionals side and in to national registers in EU member states.
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