Biomaterial Database

Postmarketing surveillance of quinolones, 1990 to 1992. 1993

P Davey, and T McDonald

Ninewells Hospital and Medical School, Dundee, Scotland.

During the last 2 years, the major event in the postmarketing surveillance of quinolones has been the worldwide withdrawal of temafloxacin after only 15 weeks on the USA market. The Adverse Drug Reaction (ADR) reports that led to the withdrawal have been reviewed and show that the frequency and type of ADR and serious ADR were highly unusual in comparison with other quinolones marketed in the USA (ciprofloxacin, norfloxacin and ofloxacin). The difficulty in establishing causality between drugs and ADRs is discussed. Prescription event monitoring and computerised databases are beginning to reach the size required to pick up rare ADRs but, even so, they can only establish association rather than causality. Perhaps a more important question is the issue of acceptable risk. This requires better definition in order to apply decision analysis to the options available for the treatment of bacterial infections.

UI	MeSH Term	Description	Entries
D006760	Hospitalization	The confinement of a patient in a hospital.	Hospitalizations
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000890	Anti-Infective Agents	Substances that prevent infectious agents or organisms from spreading or kill infectious agents in order to prevent the spread of infection.	Anti-Infective Agent,Anti-Microbial Agent,Antimicrobial Agent,Microbicide,Microbicides,Anti-Microbial Agents,Antiinfective Agents,Antimicrobial Agents,Agent, Anti-Infective,Agent, Anti-Microbial,Agent, Antimicrobial,Agents, Anti-Infective,Agents, Anti-Microbial,Agents, Antiinfective,Agents, Antimicrobial,Anti Infective Agent,Anti Infective Agents,Anti Microbial Agent,Anti Microbial Agents
D000900	Anti-Bacterial Agents	Substances that inhibit the growth or reproduction of BACTERIA.	Anti-Bacterial Agent,Anti-Bacterial Compound,Anti-Mycobacterial Agent,Antibacterial Agent,Antibiotics,Antimycobacterial Agent,Bacteriocidal Agent,Bacteriocide,Anti-Bacterial Compounds,Anti-Mycobacterial Agents,Antibacterial Agents,Antibiotic,Antimycobacterial Agents,Bacteriocidal Agents,Bacteriocides,Agent, Anti-Bacterial,Agent, Anti-Mycobacterial,Agent, Antibacterial,Agent, Antimycobacterial,Agent, Bacteriocidal,Agents, Anti-Bacterial,Agents, Anti-Mycobacterial,Agents, Antibacterial,Agents, Antimycobacterial,Agents, Bacteriocidal,Anti Bacterial Agent,Anti Bacterial Agents,Anti Bacterial Compound,Anti Bacterial Compounds,Anti Mycobacterial Agent,Anti Mycobacterial Agents,Compound, Anti-Bacterial,Compounds, Anti-Bacterial
D012307	Risk Factors	An aspect of personal behavior or lifestyle, environmental exposure, inborn or inherited characteristic, which, based on epidemiological evidence, is known to be associated with a health-related condition considered important to prevent.	Health Correlates,Risk Factor Scores,Risk Scores,Social Risk Factors,Population at Risk,Populations at Risk,Correlates, Health,Factor, Risk,Factor, Social Risk,Factors, Social Risk,Risk Factor,Risk Factor Score,Risk Factor, Social,Risk Factors, Social,Risk Score,Score, Risk,Score, Risk Factor,Social Risk Factor
D015363	Quinolones	A group of derivatives of naphthyridine carboxylic acid, quinoline carboxylic acid, or NALIDIXIC ACID.	Ketoquinoline,Ketoquinolines,Oxoquinoline,Oxoquinolines,Quinolinone,Quinolinones,Quinolone
D016208	Databases, Factual	Extensive collections, reputedly complete, of facts and data garnered from material of a specialized subject area and made available for analysis and application. The collection can be automated by various contemporary methods for retrieval. The concept should be differentiated from DATABASES, BIBLIOGRAPHIC which is restricted to collections of bibliographic references.	Databanks, Factual,Data Banks, Factual,Data Bases, Factual,Data Bank, Factual,Data Base, Factual,Databank, Factual,Database, Factual,Factual Data Bank,Factual Data Banks,Factual Data Base,Factual Data Bases,Factual Databank,Factual Databanks,Factual Database,Factual Databases
D016907	Adverse Drug Reaction Reporting Systems	Systems developed for collecting reports from government agencies, manufacturers, hospitals, physicians, and other sources on adverse drug reactions.	Adverse Drug Reaction Reporting System,Drug Reaction Reporting Systems, Adverse
D024841	Fluoroquinolones	A group of QUINOLONES with at least one fluorine atom and a piperazinyl group.	Fluoroquinolone