Comparison of the safety of several nonsteroidal anti-inflammatory drugs currently or formerly marketed in the United Kingdom.
Reports of suspected adverse reactions to nonsteroidal anti-inflammatory drugs (NSAIDs) were related to estimated numbers of prescriptions for these drugs during the years 1968 to 1981. The 16 drugs first marketed during this period had similarly high initial rates of adverse effects reported, followed by a rapid decline. There was a marked variation between drugs in initial reporting rates. A number of factors may confound comparisons between drugs and appeared to apply to two drugs: fenbufen, for which the numbers of reports was increased by reports from a postmarketing surveillance study, and zomepirac, which was labeled and tested as a general analgesic (i.e., differently from the other NSAIDs). Otherwise, the drugs with higher initial rates of reported adverse experiences later were withdrawn from the market. Naproxen and ketoprofen, which were marketed the same year (1973) and used continuously for over 14 years in the United Kingdom, were associated with similar reporting patterns that were different from those for many other NSAIDs. It is concluded that anomalies in the frequency and pattern of suspected drug-related adverse reactions in the absence of any confounding factor are an important signal of the need for further investigation.
Speirs
C J
CJ
Department of Clinical Pharmacology, Royal Postgraduate Medical School, London, England.
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D006801:Humans; D013223:Statistics as Topic; D013997:Time Factors; D006113:United Kingdom
D000894:Anti-Inflammatory Agents, Non-Steroidal