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active acute advertising agents amphenicol antibiotic aplastic anemia aspirin batch blood dyscrasias blood studies bone marrow capsules cause cells cent Chairman changes chemical chloram chloramphenicol chloramphenicol therapy Chloromycetin chronic Clin clinical committee CUTLER DAMESHEK Davis death disease doctor dosage dose double-blind Drug Administration drug product efficacy evaluation evidence fatal Food and Drug GODDARD GORDON granulocytopenia HODGES hospital indicated Indocin indomethacin infections investigators labeling laboratory Lepper leukemia leukopenia LUECK manufacturing marrow depression Medicine ment months O'BRIEN occur package insert pancytopenia Parke Parke-Davis patients penicillin peptic ulcer percent pharmaceutical phenicol phenylbutazone physician placebo prescribed prescription quality control received record Registry reported respiratory response rheumatic rheumatoid arthritis Senator NELSON serious side effects SLESSER specific standards statement submitted symptoms tablets tests tetracycline therapeutic thrombocytopenia tion toxic treated treatment trial ulcer warning WESTON
Page 2523 - ... in the Superior Court of the State of Washington in and for the county of Adams, at , Washington.
Page 2959 - Because of the high potency of the drug and the variability of its potential to cause adverse reactions, the following are strongly recommended: 1) the lowest possible effective dose for the individual patient should be prescribed. Increased dosage tends to increase adverse...
Page 2620 - Warning: Serious and even fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, granulocytopenia) are known to occur after the administration of chloramphenicol. Blood dyscrasias have occurred after both short-term and prolonged therapy with this drug. Bearing in mind the possibility that such reactions may occur, chloramphenicol should be used only for serious infections caused by organisms which are susceptible to its antibacterial effects. Chloramphenicol should not be...
Page 2637 - Precautions: It is essential that adequate blood studies be made during treatment with the drug. While blood studies may detect early peripheral blood changes, such as leukopenia, reticulocytopenia, or granulocytopenia, before they become irreversible, such studies cannot be relied on to detect bone marrow depression prior to development of aplastic anemia.
Page 2346 - If the primary objective is to make further improvements on the product or process, then the work comes within the definition of research and development. If, on the other hand, the product or process is substantially "set...
Page 2606 - I am not trying to whitewash this drug, or the excessive use of this drug by the medical profession, or be in a defensive posture with respect to the Food and Drug Administration's certification of the drug. I am simply trying to point out there are instances where it is properly prescribed, and it will still cause problems. The agency has, since 1952, made attempts to curb the excessive usage of this drug, and we will continue to try to reduce this to its proper level of usage. I do not want you...
Page 2171 - In addition, there have been reports of aplastic anemia attributed to chloramphenicol which later terminated in leukemia. Blood dyscrasias have occurred after both short-term and prolonged therapy with this drug. Chloramphenicol must not be used when less potentially dangerous agents will be effective, as described in the INDICATIONS section.
Page 2599 - Commissioner of the Food and Drug Administration, US Department of Health, Education, and Welfare.
Page 2358 - ... with the drug: Such Information should include identification of the person who conducted each investigation; identification and qualifications of the individuals who evaluated the results and concluded that it is reasonably safe to initiate clinical investigations...
Page 2409 - Preliminary blood serum level studies revealed unusually high concentrations of chloramphenicol (over 90 meg/ml after repeated doses). f) Termination of therapy upon early evidence of the associated symptomatology frequently reversed the process with complete recovery. ADMINISTRATION Chloramphenicol, like other potent drugs, should be prescribed at recommended doses known to have therapeutic activity.