Value of Epidemiologic Studies in Determining the True Incidence of Adverse Events

Miwa, Linda J.; Jones, Judith K.; Pathiyal, Atul; Hatoum, Hind T.

doi:10.1001/archinte.1997.00440390131016

Cited by 30 publications

(2 citation statements)

References 34 publications

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“…The use of claims databases to assess and evaluate adverse drug reactions in populations has been well documented. [17][18][19] This research project was approved by the institutional review board of the University of Cincinnati Medical Center, Cincinnati, Ohio.…”

Section: Research Design and Data Sourcementioning

confidence: 99%

Acute Pancreatitis Associated with Different Combination Therapies in Patients Infected with Human Immunodeficiency Virus

Guo¹,

Jang²,

Louder³

et al. 2005

Pharmacotherapy

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Section: Research Design and Data Sourcementioning

confidence: 99%

Acute Pancreatitis Associated with Different Combination Therapies in Patients Infected with Human Immunodeficiency Virus

Guo¹,

Jang²,

Louder³

et al. 2005

Pharmacotherapy

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“…22 The failure to detect such severe hepatotoxicity during drug development in part relates to the relatively short time during which patients are studied, the small num- bers of patients involved in clinical trials, and the infrequent occurrence of such severe reactions. 23 The patients reported in this case series had severe hepatotoxicity at presentation that did not improve despite drug cessation and supportive measures. Female sex and daily bromfenac use in excess of 90 days were the only identifiable risk factors.…”

Section: Discussionmentioning

confidence: 80%

Acute liver failure associated with prolonged use of bromfenac leading to liver transplantation

et al. 1999

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, § and the Acute Liver Failure Study GroupBromfenac, a nonnarcotic analgesic nonsteroidal anti-inflammatory drug, was associated with reversible, minor elevations in serum aminotransferase levels during clinical trials. The aim of this study is to describe the clinical, laboratory, and histological features of 4 patients with severe bromfenac hepatotoxicity identified at 3 tertiary care centers participating in the US Acute Liver Failure Study Group. Bromfenac was administered for chronic musculoskeletal disorders to 4 women in therapeutic doses of 25 to 100 mg/d for a minimum of 90 days. All patients reported a prodrome of malaise and fatigue and presented with severe, symptomatic hepatocellular injury with associated hypoprothrombinemia. None of the subjects had underlying liver or kidney disease, and there was no evidence of a hypersensitivity reaction. Other identifiable causes of acute liver failure were uniformly excluded. Despite supportive measures, all the subjects developed progressive liver failure over 5 to 37 days, leading to emergency liver transplantation in 3 patients and death in 1 patient while awaiting transplantation. Extensive confluent parenchymal necrosis that appeared to begin in the central zones and was accompanied by a predominantly lymphocytic infiltrate was noted in all the livers examined. Nodular regeneration was seen in the 2 patients with a more protracted clinical course. Administration of therapeutic doses of bromfenac for greater than 90 days was associated with the development of acute liver failure leading to liver transplantation or death in 4 adult women. The poor outcomes observed in this series, coupled with the inability to identify individuals at risk for severe, idiosyncratic bromfenac hepatotoxicity, preclude further use of bromfenac in the medical community.

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Time to Act on Drug Safety

Moore

Psaty

Furberg

1998

JAMA

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Value of Epidemiologic Studies in Determining the True Incidence of Adverse Events

Cited by 30 publications

References 34 publications

Acute Pancreatitis Associated with Different Combination Therapies in Patients Infected with Human Immunodeficiency Virus

Acute Pancreatitis Associated with Different Combination Therapies in Patients Infected with Human Immunodeficiency Virus

Acute liver failure associated with prolonged use of bromfenac leading to liver transplantation

Time to Act on Drug Safety

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