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Dept of Health

Answer

Jim Dobbin: To 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 Johnson: As 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 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. 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.

Secondary information

Type

Written question

Reference

146479; 416 c613-4W;416 c611-2W

Session

2003-04

Subjects

Death Abortion Drugs Monitoring Side effects Mifepristone Yellow card scheme

Link

View this Written question on www.publications.parliament.uk