Dáil Éireann Debate, Wednesday - 5 February 2025
1037. Deputy Peadar Tóibín asked 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]
Amharc ar fhreagraIn 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.
