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II (continued): How were 18 important adverse reactions discovered and with what delays?"],"prefix":"10.1136","volume":"286","author":[{"given":"G R","family":"Venning","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[1983,1,29]]},"reference":[{"key":"ref_1","article-title":"Table II gives the time lags and best estimates ofincidence30-33","volume-title":"of these seven reactions. Their incidence was of the order of 10-4. Clearly a sample size of the order of 10 000 as envisaged in many proposals for recorded-release schemes would have been inadequate for earlier first alerting to any of these major problems; 100 000 would usually have been necessary. Phenylbutazone aplastic anaemia had an even lower incidence. I have shown elsewhere34 that haematological effects are the biggest single class of suspected adverse reactions that are not subsequently verified; possibly because a particularly low incidence is not unusual with these reactions, which may present a special problem for identification. For these reactions a registry approach may represent the only feasible possibility for earlier detection, as carried out for a time by the American Medical Association after chloramphenicol aplastic anaemia","year":"1979","unstructured":"Table II gives the time lags and best estimates ofincidence30-33 (P D Fowler, personal communication, 9 July 1979) of these seven reactions. Their incidence was of the order of 10-4. Clearly a sample size of the order of 10 000 as envisaged in many proposals for recorded-release schemes would have been inadequate for earlier first alerting to any of these major problems; 100 000 would usually have been necessary. Phenylbutazone aplastic anaemia had an even lower incidence. I have shown elsewhere34 that haematological effects are the biggest single class of suspected adverse reactions that are not subsequently verified; possibly because a particularly low incidence is not unusual with these reactions, which may present a special problem for identification. For these reactions a registry approach may represent the only feasible possibility for earlier detection, as carried out for a time by the American Medical Association after chloramphenicol aplastic anaemia."},{"key":"ref_2","first-page":"39","article-title":"Pseudomembranous colitis following Aureomycin and chloramphenicol","volume":"54","author":"Reiner, L.; Schlesinger, M.J.; Miller, G.M.","year":"1952","unstructured":"Reiner L, Schlesinger MJ, Miller GM. Pseudomembranous colitis following Aureomycin and chloramphenicol. 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