To ask the Secretary of State for Health, if his Department will undertake a review of the potential abortifacient effect of ellaOne, the ulipristal acetate 30 mg tablet; and if he will make a statement.
21 December 2017
During the time period 1 January 2016 to 31 December 2016, it is estimated that approximately 90,500 tablets of ellaOne 30mg were dispensed against a prescription in pharmacies in the United Kingdom. In addition, it is estimated that there were a further 39,000 tablets of ellaOne 30mg purchased ‘over the counter’ in pharmacies (i.e. without a prescription) in the United Kingdom during the same time period.
This usage data does not capture provision of ellaOne via family planning clinics or stock ordered directly from the manufacturer, via other hospitals or other wholesalers not captured by the database, and therefore some usage for ellaOne will not be included in these figures. For these reasons, the data should be interpreted with caution.
The source of this data is MIDAS Quintiles.
EllaOne is an ulipristal acetate-containing emergency hormonal contraceptive that is licensed for use within five days of unprotected sexual intercourse or contraceptive failure. It is classified as a female emergency contraceptive; it is not an abortifacient. It exerts its contraceptive action by preventing or delaying ovulation. EllaOne has never been studied as an abortifacient. It is not intended for use during pregnancy and should not be taken by any woman suspected or known to be pregnant.
Following a High Court ruling in 2002, emergency contraception is a method of contraception not abortion. The decision confirms the Government’s long held position that a pregnancy begins at implantation and not fertilisation. This judgment means that this position is now established in law and is not a matter of policy.
As with all other licensed medicines, the Medicines and Healthcare products Regulatory Agency (MHRA) keeps the safety of ellaOne under close review using a wide number of data sources. These include reports of suspected adverse drug reactions which include pregnancies; spontaneously provided by health professionals and patients through the ‘Yellow Card scheme’. Other sources of data that the MHRA reviews on a regular basis, and which may include information on safety and/or lack of efficacy or inappropriate use, include periodic safety update reports, renewals and variations to product licences. The MHRA also reviews important published medical literature and the results of any new clinical trials or epidemiological studies as they become available.
As with all marketed medicines, the MHRA will continue to monitor the use of ellaOne. In the event that these monitoring processes identify information that suggest that ellaOne is used outside of its licensed indication, advice will be sought from the Commission on Human Medicines and its expert advisory groups. There are post-marketing regulatory measures in place to ensure that ellaOne is used as safely as possible. These measures include a European Union-wide pregnancy registry which collects data on pregnancy outcomes (including pregnancy maintenance and effects on the foetus or newborn) following exposure to ellaOne for any reason. The registry is available at the following link:
Women and healthcare professionals involved in the care of pregnant women are asked to report ellaOne exposed pregnancies to the registry via the ellaOne prescribing information and patient leaflet, as well as via yearly letters sent by the marketing authorisation holder. Abortion clinics in particular are requested to ensure that every pregnant woman is asked whether she has taken emergency contraception and if so, to specify which product.
The world-wide data available to date, including data from the EU pregnancy registry, do not suggest any safety concerns following exposure to ellaOne during pregnancy.