227923 - Contraceptives (Answered)

Fiona Bruce
To ask the Secretary of State for Health, what arrangements are in place to monitor side-effects resulting from women's use of emergency hormonal contraception.

George Freeman

In the United Kingdom emergency hormonal contraception is available from pharmacies, with or without prescription as Levonelle/Levonelle One Step (levonorgestrel-containing products) and as ellaOne (containing ulipristal acetate). Product licences were granted following advice from the UK’s Commission on Human Medicines (formerly the Committee on Safety of Medicines) and the European Union’s Committee for Medicinal Products for Human Use respectively, based on a review of all the available evidence for safety, efficacy and quality.

As with all other licensed medicines, the Medicines and Healthcare products Regulatory Agency (MHRA) keeps the safety of emergency hormonal contraception under close review using a number of data sources. These include reports of suspected adverse drug reactions, provided by health professionals and patients through the ‘Yellow Card scheme’ , periodic safety update reports, published medical literature and the results of any new clinical trials or epidemiological studies. Any of these data sources may include information on single use, repeat use or suspected long-term adverse effects.

No clinical studies of the long term safety of emergency hormonal contraception have been conducted. However, levonorgestrel has been available worldwide since the 1980s. Since then millions of women have used it for emergency contraception and no major safety concerns have arisen. For the more recently authorised ellaOne a pregnancy registry to collect further information on the safety of ellaOne has been established and could yield long-term safety data in the future. Clinical trial data show that the safety of repeated administration of ellaOne is comparable with that of a single dose. Information provided for health professionals and women advises that emergency hormonal contraception should be used as an occasional method and encourages repeat users to seek advice on regular contraception.

As with all marketed medicines, the MHRA will continue to monitor the use of emergency hormonal contraception.