Benoxaprofen

General information

Since benoxaprofen, like zomepirac, provided an experience from which several lessons can be learnt, it deserves to be briefly reviewed, even though it was withdrawn 10 years ago. Some newer drugs may have some of its chemical or pharmacological characteristics and, consequently, its problems. Benoxaprofen was originally launched in 1980, with claims of a favorable adverse effects profile and “unique disease-modifying properties” in rheumatoid arthritis. These claims appeared to have been based on the fact that it was a relatively more potent inhibitor of leukotriene production and a less potent inhibitor of prostaglandin synthesis than other NSAIDs. Having passed all preclinical and clinical tests and satisfied the safety requirements set by regulatory authorities in many countries (despite rejection in several on grounds of safety), benoxaprofen was then suspended by the UK Committee on Safety of Medicines in 1982, about 18 months after marketing. Shortly afterwards it was withdrawn worldwide by its manufacturers [ ]. Benoxaprofen was associated with a very high incidence of adverse effects, prominent effects on the skin and nails and liver reactions, which sometimes proved fatal, particularly in elderly people.

The case led to considerable regulatory and medicolegal discussions in the 10 years after withdrawal. In the USA the company was charged by the Food and Drug Administration with misbranding the drug in press statements and associated materials, which contained a misleading headline implying that the drug was harmless, even though the company was aware of a report of deaths related to the use of benoxaprofen. The company’s intense marketing campaign was heavily criticized [ ] and it was noted that the recommendation of the WHO that drugs likely to be used in elderly people should be investigated in them at an early stage had certainly been disregarded in the premarketing phases. In the UK the company rejected patients’ demands to establish a compensation scheme and offered instead a financial settlement that the patients rejected as inadequate. The case shows how some legal systems are inadequate for dealing with mass claims of personal injury due to drugs.

Organs and systems