HC Deb 19 January 1993 vol 217 cc222-3W
Mr. Cousins

To ask the Secretary of State for Health what assessment has been made of the side effects of azapropazone; how many cases of such side effects have come to her attention; what consideration the Committee on Safety of Medicines is giving to this matter; and what central guidance on the side effects has been given to general practitioners.

Dr. Mawhinney

The safety of all licensed medicines, including azapropazone, is constantly monitored by the Medicines Control Agency. As part of this process, the Committee on Safety of Medicines (CSM) operates a yellow card scheme for physicians to report suspected adverse reactions to drugs. Under this scheme, CSM has received 2,041 reports of adverse reactions which may be associated with azapropazone. A report of a suspected reaction in association with a drug does not necessarily mean that the drug caused the effect reported. Azapropazone belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs) used in the treatment of rheumatic disease and other musculoskeletal disorders. More reports of suspected adverse reactions are received in association with this group of drugs than any others, reflecting their wide usage.

A number of studies are being conducted comparing the relative safety of different NSAIDs. CSM will be reviewing these studies when the results become available and, if necessary, will issue advice to prescribers. It has been recognised for some years that NSAIDs can cause serious gastrointestinal reactions such as bleeding and perforation of ulcers. This problem was drawn to the attention of doctors by the CSM in articles in the British Medical Journal in March and May 1986 and in its bulletin "Current Problems No. 16" issued in 1986. No specific guidance has been issued by CSM regarding the side effects of azapropazone. Information is available to physicians in the British National Formulary, which the Department issues free of charge to all prescribers, and in the data sheet for products, which are produced by the manufacturers and authorised by the licensing authority.

Mr. Cousins

To ask the Secretary of State for Health what has been the expenditure on azapropazone in cash terms, and as expenditure per 1,000 population in each NHS region and health district in 1991–92.

Dr. Mawhinney

I shall let the hon. Member have such information as is available as soon as possible.