The European Medical Agency’s safety assessment committee (PRAC) has concluded that the currently available evidence is not sufficient to establish a causal relationship between the use of the antibiotic doxycycline and the risk of suicidality.
Doxycycline is a broad-spectrum antibiotic, widely used to treat a wide range of infections caused by bacteria such as acne, urinary and lower respiratory tract infections, dental infections and skin infections. It is also used to prevent the development of certain infections, like malaria.
A safety signal on the risk of suicidality, suicidal thoughts or actions with doxycycline was raised based on cases reported to the Finnish national competent authority, as well as further cases reported to EudraVigilance, the centralised European database of suspected side effects reports, and the medical literature.
The PRAC started its review in November 2023 and requested the marketing authorisation holders for doxycycline to perform a cumulative review of the data from all relevant sources.
The PRAC also requested a study based on real-world evidence, which includes data from electronic health records and disease registries, through DARWIN EU to facilitate the assessment of the signal.
After reviewing all available evidence from spontaneous reports, the literature, the discussion on possible mechanisms and the study performed via DARWIN EU, the PRAC considered that the evidence is not sufficient to establish a causal relationship and that no update to the product information of doxycycline is warranted.
Suicide-related events in relation to doxycycline will be closely monitored and any new evidence will be discussed in the Periodic Safety Update Reports (PSURs).
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