HC Deb 13 May 1982 vol 23 cc307-8W
Mrs. Renée Short

asked the Secretary of State for Social Services (1) what investigations have been carried out into the safety aspects of the drug Opren; and under what terms it is licensed to be used;

(2) for the treatment of what kinds of illnesses the drug Opren is prescribed; and if he is satisfied that it is safe;

(3) what advice is issued to doctors concerning the precription of Opren to patients, especially the elderly;

(4) what evidence there is of adverse side effects in patients using the drug Opren.

Mr. Kenneth Clarke

Benoxaprofen—Opren—is an anti-inflammatory drug available on prescription only which is licensed for the treatment of rheumatoid arthritis and osteoarthritis. The product data sheet, which is made available to all medical practitioners by the pharmaceutical company concerned, includes prescribing advice to doctors including warnings of possible side effects. The drug is contra-indicated for patients who are hypersensitive to it, have active peptic ulceration, or sensitivity to other anti-inflammatory agents. It should be used with caution in patients with impaired liver function and a reduced dose is recommended in patients with impaired kidney function, which includes many elderly or frail patients.

The drug was subject to full investigation and testing before it was granted a product licence on the advice of the Committee on Safety of Medicines and clinical use has been closely monitored since it was marketed in 1980. Adverse effects reported to have been associated with treatment with benoxaprofen have included gastrointestinal symptoms, photosensitivity, hypersensitivity reactions—for example, skin rash, itching—impairment of liver and kidney function, ophthalmic symptoms and nail disorders. These effects are common to other drugs in this group, but photosensitivity and nail disorders appear to occur more commonly with benoxaprofen than with other similar drugs. The company issued a warning to all doctors in August 1981, following discussion with the CSM, concerning the incidence of photosensitivity, other skin reactions, and nail disorders, and providing advice on measures to lessen these effects.

The adverse reactions associated with benoxaprofen are currently under consideration by the CSM, which will advise the licensing authority regarding any action which may be considered necessary on grounds of safety.