Carol Nolan (Laois-Offaly, Independent)
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746. To ask the Minister for Health if the HSE has been notified of significant adverse outcomes including hospitalisation in women who were prescribed mifepristone and misoprostol in 2019 and to date in 2020. [23807/20]

Stephen Donnelly (Wicklow, Fianna Fail)
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In Ireland, the Health Products Regulatory Authority (HPRA), is responsible for monitoring the safety of medicines, which is also known as, pharmacovigilance. As such, the HPRA operates the national adverse reaction reporting system. 

During 2019, and to date in 2020, the HPRA has not received any reports of suspected adverse reactions in association with misoprostol or mifepristone which resulted in significant outcomes including hospital admissions.

Since adverse reaction reports may contain limited information, I have also referred this PQ to the HSE for direct response to the Deputy on the matter.

Healthcare professionals (including doctors, dentists, pharmacists and nurses) are requested to report suspected adverse reactions observed in their practice to the HPRA.

In addition, the HPRA also encourages patients, carers and other members of the public to report suspected adverse reactions to it via its online reporting system.