Ovarian Hyperstimulation Syndrome

(asked on 23rd March 2015) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, with reference to the Answers of 2 December 2014 to Question HL2907 and 17 March 2015 to Question HL5319 and the Written Statement of 24 November 2010, Official Report, columns WS101-2, on Questions for Written Answer: Correction, how many incidents of hospitalisation due to ovarian hyperstimulation syndrome (OHSS) have been reported to the Human Fertilisation and Embryology Authority (HFEA); what steps the HFEA takes to ensure that any suspected serious adverse reactions are reported to the licensing authority in accordance with the Human Medicines Regulations 2012; what steps the HFEA takes in cases of failure to report any such incidents to the Medicines and Healthcare Products Regulatory Agency; and whether he is satisfied that the HFEA is doing enough to protect patients from OHSS.


Answered by
 Portrait
Jane Ellison
This question was answered on 26th March 2015

The information the Human Fertilisation and Embryology Authority (HFEA) holds on number of incidents of hospitalisation due to ovarian hyperstimulation syndrome (OHSS), that have been reported to the Authority, is set out in the written answer provided to the then hon. Member for Heywood and Middleton on 24 June 2014, Official Report, columns 156-157W (UIN 201565).

The HFEA has advised that the responsibility for reporting adverse reactions in accordance with the Human Medicines Regulations 2012 rests with clinics and the treating clinician. Should the HFEA be made aware of information relevant to the regulatory functions of the Medicines and Healthcare products Regulatory Agency, this information would be shared between the two organisations.

The Department is satisfied that the Authority is fulfilling its statutory duties as set out in the Human Fertilisation and Embryology Act 1990, as amended.

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