What can a spontaneous reporting system teach about side-effects of anti-inflammatory drugs?

Abstract

The launch of a new anti-inflammatory drug (or any drug, for that matter) is preceded by appropriate defined testing in most industrialized nations. Although the requirements for demonstrating efficacy and safety vary from country to country, they can usually be satisfied by including from a few hundred to 3000 patients in pre-approval testing. In countries without the requisite infrastructure, drugs may be licensed without local testing, accepting data generated elsewhere. These limited studies give considerable insight into the proper use of the drugs in question. They also identify the major frequent untoward events that accompany administration of the drugs, and permit segregation — because of the relatively controlled conditions — of those events causally related from those that are casual interlopers. Generally, it is left to post-marketing studies to delve deeper into specific side-effect liabilities. If, in pre-approval studies, serious side-effects or fatalities occur, and if these can be related to the drug, then approval is placed in jeopardy, depending on the severity of the condition to be treated, the benefits expected and the risks found acceptable. For non-steroidal anti-inflammatory drugs (NSAIDs) the benefit-risk ratio acceptable is more rigorous than for compounds thought capable of altering the disease progression to crippling or death. This assumes that NSAIDs provide no discernable benefits other than pain relief and inflammation suppression, an arguable proposition.