Dáil Éireann Debate, Wednesday - 5 February 2025
1038. Deputy Peadar Tóibín asked the Minister for Health the number of reports of adverse effects, including suicidality, that the EMA has received for Doxcycline over the past 20 years; and the number of reports of deaths associated with Doxcycline received by the EMA over the past 20 years. [2194/25]
View answerIn order to inform a response to your question, my Officials have reached out to the Health Products Regulatory Authority (HPRA), our national competent authority for medicines.
The European Medicines Agency (EMA) operates the EudraVigilance system, which is used to manage and analyse information on suspected adverse reactions. It supports the safe and effective use of medicines by facilitating electronic exchange of information and early detection and evaluation of possible safety signals. The EMA make EudraVigilance data, anonymised following data protection requirements, accessible to the public on www.adrreports.eu.
It is important to understand that conclusions on the safety of a medicine cannot be drawn based on the information from suspected adverse reactions alone, given well-established and known limitations in interpreting such data in isolation.
The number of individual cases identified in EudraVigilance for doxycycline via the adrreports.eu website is just over 14,000, including reports from both EEA and non-EEA areas since the system was first established in the 1990s. Of those, a relatively small number describe suicide or suicidal ideation, some of which had a fatal outcome. The specific numbers are available publicly through the website, together with additional guidance on interpreting the information.
Should the Deputy wish to obtain any data unavailable through the public website, additional time will be needed for the HPRA to liaise with the EMA to request this data. The HPRA have indicated that they would be happy to do so.
It is also noted that all EudraVigilance data relevant to the concerns around suicide were examined as part of the EMA's signal management procedure, which was recently completed. Based on that review, evidence to support a causal association between doxycycline and suicide/suicidal ideation was not established; however, the matter will continue to be monitored.
