Differences in Manufacturer Reporting of Adverse Drug Reactions to the FDA in 1984

Baum, Carlene; Faich, Gerald A.; Anello, Charles; Forbes, Mary B.

doi:10.1177/009286158702100302

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Triazolam (Halcion) Is a Triazolobenzodiazepine Ultra-1

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1988

1995

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Cited by 8 publications

(1 citation statement)

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“…In August 1979, the Dutch Ministry of Health suspended marketing of triazolam and later withdrew the drug's registration. 3,4 Subsequently, in a letter to Lancet, van der Kroef5 reported that he had 25 patients in whom triazolam had produced numerous behavioral side effects, including hallucina¬ tions, amnesia, aggression, depression, and depersonalization.…”

Section: Triazolam (Halcion) Is a Triazolobenzodiazepine Ultra-mentioning

confidence: 99%

Adverse Behavioral Reactions Attributed to Triazolam in the Food and Drug Administration's Spontaneous Reporting System

Wysowski¹

1991

Arch Intern Med

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Section: Triazolam (Halcion) Is a Triazolobenzodiazepine Ultra-mentioning

confidence: 99%

Adverse Behavioral Reactions Attributed to Triazolam in the Food and Drug Administration's Spontaneous Reporting System

Wysowski¹

1991

Arch Intern Med

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Adverse Drug Event Reporting

Edlavitch¹

1988

Arch Intern Med

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Defining, Monitoring and Combining Safety Information in Clinical Trials

Enas

Goldstein

1995

Statistics in Medicine

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Assessment of clinical trial safety data for industry, regulatory agencies, medical practitioners and patients requires definition and measurement, monitoring, and overall analysis. Prospective 'safety' definitions and reliable measurement tools reduce inefficient data collection and improve the validity of resulting analyses. Statistical tools can help investigators monitor safety data from controlled clinical trials and help improve post-marketing surveillance. Also, when evaluating overall safety, one needs to assess all available information by combining information from many trials and other sources. Planning for this combined assessment, incorporating flexibility to assess unanticipated yet important nuances in individual trials, may be more important than the actual statistical analysis method used. A keen awareness of the future needs of consumers of this information is quite important. Some current proposals to combine safety information will be discussed.

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Differences in Manufacturer Reporting of Adverse Drug Reactions to the FDA in 1984

Cited by 8 publications

References 5 publications

Adverse Behavioral Reactions Attributed to Triazolam in the Food and Drug Administration's Spontaneous Reporting System

Adverse Behavioral Reactions Attributed to Triazolam in the Food and Drug Administration's Spontaneous Reporting System

Adverse Drug Event Reporting

Defining, Monitoring and Combining Safety Information in Clinical Trials

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