The currently available evidence is not sufficient to establish a cause and effect relationship between the use of the antibiotic doxycycline and the risk of suicidality, the safety committee of the European Medicines Agency (PRAC) indicated in early December. A security signal led to the opening of an investigation in 2023.
Remain vigilant when prescribing it as with isotretinoin
Doxycycline is a broad-spectrum antibiotic, widely used to treat a range of infections caused by bacteria, such as acne, urinary and lower respiratory infections, dental infections, and skin infections. It is also used to prevent the development of certain infections, such as malaria.
A safety signal regarding the risk of suicidality, suicidal thoughts or actions with doxycycline has been issued based on cases reported to the Finnish national competent authority, as well as other cases reported to EudraVigilance, the basis for Centralized European data of reports of suspected side effects, and medical literature.
Note that several cases suggesting a link between taking the antibiotic and suicidal thoughts, or even acts of suicide, have been published in the literature in recent years, including one recently by the Angers University Hospital in which the authors call on the dermatologist to “keep in mind the impact of doxycycline on the central nervous system and mental health in general, remain vigilant when prescribing it as for isotretinoin, identify the warning signs of a psychotic decompensation and knowing how to alert pharmacovigilance”.
A vast investigation
The PRAC began its review in November 2023 and requested marketing authorization holders of doxycycline to carry out a cumulative review of data from all relevant sources.
The PRAC also requested a real-world evidence-based study, which includes data from electronic medical records and disease registries, through DARWIN EU, to facilitate the assessment of the signal.
Having reviewed all available data from spontaneous reports, literature, possible mechanisms and the study carried out via DARWIN EU, the PRAC considered that the data are not sufficient to establish a cause and effect relationship and that no update of the information relating to 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 (PSUR),” the EMA concludes.
In France, the medicines currently marketed and concerned are the following:
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Doxy 50 and 100 mg, film-coated tablet;
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Doxycycline Arrow100 mg, film-coated tablet;
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Doxycycline Biogaran 100 mg, scored film-coated tablet;
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Doxycycline Central Pharmacy of the Armed Forces 100 mg, tablet;
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Doxycycline Sandoz 100 mg, scored tablet;
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Doxycycline Teva 100 mg, scored tablet;
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Doxycycline Viatris100 mg, scored tablet;
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Doxylis 100 mg, scored tablet;
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Doxypalu 100 mg, tablet;
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Granudoxy 100 mg, scored film-coated tablet;
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Tolexin 50 and 100 mg, microgranules in tablet;
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Vibravenous, injectable solution for IV and infusion.
