§ Mr. Wigleyasked the Secretary of State for Social Services how many adverse reactions had been reported to the drug Althesin before its withdrawal by the manufacturers; and if he will make a statement.
§ Mr. Kenneth Clarke[pursuant to his reply, 11 June 1984]: Althesin, which is an injectable anaesthetic, contains the solvent cremophor EL, which has been known for some time to be associated with serious hypersensitivity reactions. The Committee on Safety of Medicines has reminded doctors on several occasions about these reactions, most recently in April 1983. In January of this year, following the suspension of the licences for certain products containing cremophor EL in Italy including Althesin, the CSM again reviewed the position but advised 462W that no licensing action was necessary in the United Kingdom. At the end of February however the manufacturers, Glaxo Ltd., decided to withdraw the product voluntarily world-wide and cancelled its United Kingdom product licences.
Between 1972, when it was first marketed in the United Kingdom, and its withdrawal in 1984 the CSM received 491 reports of suspected adverse reactions to Althesin. It is important to bear in mind that a report does not necessarily establish a causal relationship with the product.