Written question asked by Joan Walley (Labour) on Tuesday, 12 March 2002, in the House of Commons. It was due for an answer on Thursday, 18 April 2002. It was answered by Lord Hutton of Furness (Labour) on Thursday, 18 April 2002 on behalf of the Department of Health.

Dept of Health

Question: To ask the Secretary of State for Health, what research has been carried out into the side effects of myodil. - Inc figures.

Answer: Ms Walley: To ask the Secretary of State for Health what research has been carried out into the side effects of myodil. [43495] Mr. Hutton: Myodil was first marketed in the 1940s and was granted a Product Licence of Right in 1972 after the introduction of the Medicines Act 1968. Myodil has not been marketed in the UK since 1987, when the manufacturers withdrew the product for commercial reasons. At the time of licensing, published case reports and spontaneous reports received by the company and regulatory agencies led to the inclusion of a warning about the occurrence of post-myelography arachnoiditis in the product information for Myodil. There have been over 50 publications in the scientific literature relating to Myodil, including human and animal studies. These have included research in to patients who had received myodil to evaluate the risk of arachnoiditis. In general these studies do show an increased risk of arachnoiditis in patients, especially if they had a history of previous spinal surgery or spinal stenosis. When Myodil was used in procedures away from the lumbar spine there did not appear to be an increased risk. A published animal study in 1982 comparing Myodil with another contrast agent also showed an increased risk of arachnoiditis. Other studies have evaluated the use of Myodil for diagnostic procedures without looking specifically at safety or long term issues.

Secondary information