title: What to do until the FDA arrives.
abstract: The need for clinical monitoring to assure drug safety despite reliance on Food and Drug Administration testing is illustrated. The need to temper theory with clinical experience is exemplified by the recent examples of swine flu, resistant gonorrhea, and resistant pneumococcal infection. The potential for adverse effects to escape detection in animal studies and small-scale human trials is illustrated by the examples of ticrynafen, chloramphenicol, and diethylstilbestrol. The potential for unexpected side effects when established drugs are used in new ways is demonstrated by the examples of retrolental fibroplasia and vitamin D toxicity. The responsibilities of the medical profession and the individual practitioner include a healthy skepticism of newly introduced treatments, active participation in clinical monitoring, and maintenance of a system for chart retrieval when drugs are recalled or new effects reported.
mesh_terms: D002701:Chloramphenicol / Q000009:adverse effects; D002986:Clinical Trials as Topic; D004054:Diethylstilbestrol / Q000009:adverse effects; D004341:Drug Evaluation; D004335:Drug and Narcotic Control; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007252:Influenza Vaccines / Q000009:adverse effects; D012306:Risk; D013989:Ticrynafen / Q000009:adverse effects; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D007252:Influenza Vaccines; D002701:Chloramphenicol; D004054:Diethylstilbestrol; D013989:Ticrynafen