(2) when his Department last undertook a review of clinical evidence on the use of (a) mifepristone and (b) the morning-after pill that drew on (i) UK and (ii) international research; and if he will make a statement.
In the United Kingdom Mifegyne (mifepristone or RU486) is licensed for the termination of pregnancy (abortion). This product licence was granted following advice from the then Committee on Safety of Medicines (CSM) that was based on a review of all the available evidence for safety, efficacy and quality.
The Medicines and Healthcare products Regulatory Agency (MHRA), in consultation with the wider Department, has reviewed the use of emergency hormonal contraception on a number of occasions: in 2001, when Levonelle-2 was made available for sale in pharmacies as Levonelle; in 2003, when the dosing regimen was changed from taking two tablets 12 hours apart to taking them at the same time; and in relation to this, when the strength of the pill was doubled in 2004 so that only one tablet need be taken. Advice from the Committee on Safety of Medicines (now the Commission on Human Medicines) was sought on all occasions.
In 2005 the safety of mifepristone was reviewed within the UK and Europe in response to the reporting of very rare cases of fatal toxic shock following infection, reported from the United States of America, in association with the use of mifepristone and misoprostol for medical abortion. The Food and Drugs Administration concluded that no causal relationship could be established and that serious bacterial infections may occur with all types of abortion, whether spontaneous, surgical or medical. Similar cases of fatalities had not been observed in the UK or Europe. No new safety concerns were identified and no action considered necessary. We are also aware that the Royal College of Obstetricians and Gynaecologists reviewed the clinical use of mifepristone in order to update their September 2004 guideline on ‘The Care of Women Requesting Induced Abortion’. This guideline recommends pre-abortion management for all types of abortion which includes infection screening and prophylaxis.
The MHRA most recently reviewed the use of mifepristone in 2007. This review examined effectiveness and safety data relating to the use of mifepristone in combination with a prostaglandin for the termination of pregnancy up to nine weeks gestation and the balance of benefits and risks was found to be favourable. A comparison of medical versus surgical abortion found significantly more suspected pelvic infections and surgical complications, including uterine perforation that required laparoscopy, after surgical abortion. Furthermore, no significant difference in the success rates after medical abortion was observed compared with surgical abortion.
As with all licensed medicines, the safety of mifepristone and emergency hormonal contraception will continue to be monitored by the MHRA.