Doxycycline: currently available evidence not supporting link with risk of suicidality
EMA’s safety 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, such as 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…
