§ Jim DobbinTo ask the Secretary of State for Health what investigations the(a) Medicines and Healthcare Products Regulatory Agency and (b) the Committee on the Safety of Medicines have conducted into the two suspected fatal reactions associated with the use of Mifegyne; and with what results. [146479]
§ Miss Melanie JohnsonAs with all marketed medicines, the safety of Mifegyne (mifepristone, an antiprogestogenic steroid that is used for the medical termination of intra-uterine pregnancy) is continuously monitored by the Medicines and Healthcare products Regulatory Agency (MHRA).
The MHRA has carefully evaluated the two reports received via the Yellow Card Scheme of fatal suspected
Department of Health mandatory bacteraemia surveillance scheme—MRSA bacteraemia by region—Acute NHS trusts Regions Total Number S.aureus bacteraemia April 01 to March 02 Methicillin resistant Percentage Total number S.aureus bacteraemia April 02 to March 03 Methicillin resistant Percentage Percentage difference MRSA between the two years North East 931 363 39.0 953 380 39.9 4.5 Yorkshire and Humberside 2,028 714 35.2 2,086 664 31.8 -7.5 East Midlands 1,374 543 39.5 1,349 494 36.6 -9.9 Eastern 1,683 754 45.0 1,653 714 43.1 -5.6 London 3,524 1,571 44.6 3,739 1,659 44.4 5.3 South East 2,205 1,012 45.9 2,417 989 40.9 0.8 South West 1,745 696 39.9 1,756 738 42.0 5.7 West Midlands 1,863 761 40.8 1,908 812 42.6 6.3 North West 2,580 867 33.6 2,658 934 35.1 7.2 England 17,933 7,281 40.6 18,519 7,384 39.8 1.8 612W
Provisional data Strategic health authority 1Total MRSA 2Total MRSA Avon, Gloucestershire and Wiltshire 386 389 Bedfordshire and Hertfordshire 192 173 Birmingham and the Black Country 452 455 Cheshire and Merseyside 286 344 County Durham and Tees Valley 171 155 Coventry, Warwickshire,Herefordshire and Worcestershire 153 182 Cumbria and Lancashire 236 215 Dorset and Somerset 74 139 Essex 194 149 Greater Manchester 345 375 Hampshire and Isle of Wight 209 200 Kent and Medway 222 205 Leicestershire, Northamptonshire and Rutland 203 189 Norfolk, Suffolk and Cambridgeshire 368 392 North and East Yorkshire and Northern Lincolnshire 213 151 adverse reactions associated with the use of Mifegyne. This assessment has included details from the post-mortems received in the initial report or via follow-up information obtained from the marketing authorisation holder. The MHRA has concluded that the two cases did not require alteration of the advice to health professionals in the summary of product characteristics and did not affect the balance of risks and benefits of mifepristone. The Committee on Safety of Medicines was not asked to consider these cases.
The reporting of a suspected adverse drug reaction does not necessarily mean that the drug was responsible. Many factors, such as the medical condition that is being treated, other pre-existing illnesses or other medications might have contributed. In one of the cases, the fatal suspected reaction that was reported is recognised to occur with greater frequency during pregnancy or surgery, irrespective of the use of mifepristone.