Scientific Publications by FDA Staff

N Engl J Med 2013 Jun 6;368(23):2155-7

New evidence about an old drug--risk with codeine after adenotonsillectomy.

Racoosin JA, Roberson DW, Pacanowski MA, Nielsen DR

During the past 10 years, efforts in pharmacogenomics have generated insights into the efficacy and safety of drugs, enhancing our understanding of the safety profile of even some of the oldest drugs, such as codeine sulfate, an opioid analgesic first approved in 1950 for relief of mild or moderate pain. Simultaneously, an increased awareness of the value of both personalized medicine and the reporting of rare adverse outcomes has resulted in the publication of information on adverse events that previously might not have been reported. These developments, in turn, led the Food and Drug Administration (FDA) to reanalyze the safety . . .