Section 4 Adverse reactions to non-steroidal antirheumatic drugs

Abstract

The method of collection, processing and evaluation of adverse reaction reports received by the U.K. Committee on Safety of Medicines is outlined. By utilising adverse reaction profiles, the major reactions associated with established and more recently introduced antirheumatic drugs are enumerated, compared and specific problems discussed. The profiles show that both phenylbutazone and oxyphenbutazone are predominantly associated with blood dyscrasias while indomethacin is predominantly associated with gastro-intestinal haemorrhage and minor reactions affecting the central nervous system. Aspirin shows a similar profile to indomethacin but in addition, a renal component due to papillary necrosis associated with the use of combined preparations containing phenacetin. The use of gold salts and D-penicillamine is also predominantly associated with blood dyscrasias. Some specific problems related to the use of ibufenac and alclofenac are discussed, and also the current profiles of ibuprofen, naproxen and ketoprofen. Some of these profiles of human drug toxicity are considered in relation to the information which can be derived from animal toxicity studies.