Drug Efficacy: Hearings Before a Subcommittee of the Committee on Government Operations, House of Representatives, Ninety-first Congress, First Session, Volumes 74-77U.S. Government Printing Office, 1970 - Drugs |
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action adequate anesthetic antibiotic antihistamine approved April asked basis believe betahistine blood level BROWN of Michigan Bureau of Medicine capsules certification Chairman chloramphenicol succinate Chloromycetin clinical committee controlled study correct Davis decision Doctor document dosage doses Drug Administration drug application effective Elia Elia's evaluation FDA's Federal Register files firm fixed combination Food and Drug FOUNTAIN GOLDBERG GOODRICH GRAY hazard Health hearing HERBERT L Hodges indicated infections intramuscular intravenous investigation JENNINGS KIRK labeling letter Lidd memorandum Meniere's disease Meniere's syndrome ment MINCHEW National Academy novobiocin Office opinion oral Panalba panel parenteral Parke patients penicillin physicians placebo procedures question Rachelle reaction recall recommended record request response ROSENTHAL route safety Secretary Serc sodium succinate staff STANFORD statement streptomycin subcommittee submitted substantial evidence sulfonamide symptoms tetracycline therapy tion treatment Upjohn VANDER JAGT vertigo
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Page 325 - As used in this subsection and subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended,...
Page 283 - ... under the conditions of use upon the basis of which the application was approved; or (3) on the basis of new information before him with respect to such drug, evaluated together with the evidence available to him •when the application was approved, that there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling thereof...
Page 66 - HOWEVER. CHLORAMPHENICOL MAY BE CHOSEN TO INITIATE ANTIBIOTIC THERAPY ON THE CLINICAL IMPRESSION THAT ONE OF THE CONDITIONS BELOW IS BELIEVED TO BE PRESENT; IN VITRO SENSITIVITY TESTS SHOULD BE PERFORMED CONCURRENTLY SO THAT THE DRUG MAY BE DISCONTINUED AS SOON AS POSSIBLE IF LESS POTENTIALLY DANGEROUS AGENTS ARE INDICATED BY SUCH TESTS. THE DECISION TO CONTINUE USE OF CHLORAMPHENICOL RATHER THAN ANOTHER ANTIBIOTIC WHEN BOTH ARE SUGGESTED BY IN CEPTS CONTAINED IN THE WARNING BOX ABOVE: 1. Acute infections...
Page 284 - Within 30 days from the date of publication of this notice in the FEDERAL REGISTER, such persons are required to file with the Hearing Clerk, Department of Health.
Page 65 - 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 59 - It must not be used in the treatment of trivial infections or where it is not indicated, as in colds, influenza, infections of the throat; or as a prophylactic agent to prevent bacterial infections. 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...
Page 232 - This notice is issued pursuant to the provisions of the Federal Food, Drug, and Cosmetic Act (sees. 502, 507; 52 Stat.
Page 115 - Chloramphenicol should not be used when other less potentially dangerous agents will be effective, or in the treatment of trivial infections such as colds, influenza, or viral infections of the throat, or as a prophylactic agent.
Page 354 - Treatment should not be continued for longer than ten days Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin.
Page 67 - ... Treatment should not be continued longer than required to produce a cure with little or no risk of relapse of the disease. 3. Concurrent therapy with other drugs that may cause bone marrow depression should be avoided. 4. Excessive blood levels may result from administration of the recommended dose to patients with impaired liver or kidney function, including that due to immature metabolic processes in the infant.