Peadar Tóibín (Meath West, Aontú)
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1037. To ask the Minister for Health the number of reports of adverse effects, including suicidality, that the HPRA has received for doxcycline over the past 20 years; and the number of reports of deaths associated with doxcycline received by the HPRA over the past 20 years. [2193/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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In order to inform a response to your question, my Officials have reached out to the Health Products Regulatory Authority (HPRA).

The HPRA operates a reporting scheme in Ireland through which suspected adverse drug reactions (also known as side effects) can be notified. All reports are carefully evaluated by the HPRA's pharmacovigilance department per national and EU legislation and guidance. The description of suspected adverse reactions, including the number and category, reflects available information known at the time by the HPRA. These data may change as more information about individual reports becomes available through follow-ups and as reports are further evaluated.

Reports of suspected adverse reactions are submitted (with personal identifiers and contact details removed) to the EMA’s EudraVigilance database. The EudraVigilance database is regularly analysed to detect any possible safety signals related to medicines.

Over the past 20 years, the HPRA has received 67* suspected adverse drug reaction reports associated with doxycycline. Of these, two involved fatal outcomes: one was unrelated to suicide, while the other was associated with a suicide.

* Data obtained from the HPRA's National Adverse Reaction database. 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.

Peadar Tóibín (Meath West, Aontú)
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1038. To ask 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]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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In 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 .

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.

Peadar Tóibín (Meath West, Aontú)
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1039. To ask the Minister for Health to detail the investigation, if any, that was carried out by the HPRA into the death of a person (details supplied) following the taking of doxycycline. [2195/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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At the request of the Deputy, the response to this PQ has been forwarded directly to the Deputy for their attention on 4th February 2025.