§ Mr. Kenneth Clarke
flosint is the brand name of a product containing indoprofen used in the treatment of arthritis and as an analgesic. It was first marketed in the United Kingdom in September 1982 but was already on the market in West Germany and Italy and other countries in Europe and South America.
Data submitted in support of the application for a United Kingdom product licence to the Committee on Safety of Medicines indicated that the pattern and incidence of adverse reactions was likely to be similar to that of other products in its class—non-steroidal anti-inflammatory. In the period up to 6 December this year, 618W the latest date for which figures are readily available, 217 reports of suspected adverse reactions, including seven in which the patient subsequently died, were submitted to the CSM. In view of the relatively small number of patients who had been prescribed the product in the United Kingdom, these figures suggest for a drug in this class, a high incidence of possible fatal and serious reactions especially gastro-intestinal bleeding and perforation.
In a letter to the licensing authority dated 1 December the company, Farmitalia Carlo Erba Ltd, reported the result of apost-marketing study with its product undertaken in the United Kingdom. This tended to confirm the nature and incidence of serious adverse reactions reported to the CSM. As a result the company was invited to a meeting with officials of the Department on 7 December to discuss the position at which it was informed that the licensing authority would seek the advice of the CSM on the safety of Flosint at its meeting on 15 December. On 9 December, at the company's request, a further meeting took place. At this meeting the representatives of the company stated that because of the apparent hazards to patients it was its intention to withdraw the product from the United Kingdom market immediately, despite reassuring evidence on the safety of the drug from post-marketing studies undertaken in West Germany and clinical experience in other countries, until the position was clarified following representations by the company to the CSM. The United Kingdom company shortly afterwards informed a few organisations and some doctors involved in the reatment of arthritis in the United Kingom that it had decided to withdraw the product and had further brief discussions with officials on 12 December. On 13 December, after requests from the Department for information on the position, it indicated that it had decided not to proceed with a voluntary withdrawal.
I decided, in view of the severe nature and speed of onset of the reactions and the serious confusion which was likely to follow from the company's change of mind after information of a voluntary withdrawal had been given that there was no acceptable alternative but to suspend the product licence of the drug with immediate effect on the afternoon of 13 December for a period of three months. This suspension is renewable if necessary. The CSM has been informed and is now considering the future marketing of the drug.