HC Deb 29 November 1976 vol 921 cc61-2W
Mr. Pavitt

asked the Secretary of State for Social Services if he is satisfied that the drug Tagamet has been sufficiently tested; what was the length of time taken for clinical trials in the United Kingdom; and if he will make a statement.

Mr. Moyle

A product licence authorising the marketing of Tagamet (cimetidine) ampoules, tablets and syrup was granted on 8th November 1976 on the advice of the Committee on Safety of Medicines. On the evidence of results of laboratory tests and clinical trials covering administration for up to eight months in patients, the Committee was satisfied as to its safety, quality and efficacy for the currently recommended indications. This drug represents a new treatment of conditions associated with increased gastric acidity. It is the result of many years' research into a series of related compounds. The licence was granted on condition that the company submits to the licensing authority all United Kingdom reports of suspected adverse reactions in patients treated with Tagamet.