Contraceptives: Pregnancy

(asked on 19th December 2017) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, if the Medicines and Healthcare Products Regulatory Agency will review the description in ellaOne packaging that states that if you are already pregnant, it [ellaOne] will not interrupt an existing pregnancy.


Answered by
Steve Brine Portrait
Steve Brine
This question was answered on 27th December 2017

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. The information provided in each pack of ellaOne clearly informs women and healthcare professionals that it should not be taken by a woman who knows or suspect she is pregnant.

The requirements for medicines labelling are set out within Title V of Council Directive 2001/83/EC. As ellaOne is authorised throughout the European Union the labelling particulars are agreed across all member states by the European Medicines Agency. The Medicines and Healthcare products Regulatory Agency will be liaising with the European Medicines Agency to discuss whether any changes might be desirable within the terms of the marketing authorisation.

As with all other licensed medicines, the Medicines and Healthcare products Regulatory Agency keeps the safety of ellaOne under close review using a wide number of data sources.

Reticulating Splines