Spontaneous Reporting in the United States

Kennedy, Dianne L.; Goldman, Stephen A.; Lillie, Ralph B.

doi:10.1002/0470842555.ch10

Cited by 51 publications

(50 citation statements)

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“…A risk assessment of a particular drug requires analysis of the specific reports, information from clinical trials, and evaluation of the characteristics of the specific event. 3 These results do provide an overview of reported adverse events in this special population and a frame of reference for additional research on specific drugs.…”

Section: Commentmentioning

confidence: 94%

“…In addition, the volume of reports for any individual drug can be influenced by the length of time on the market, severity of underlying illness, the manufacturer's marketing and postmarket surveillance activities, and whether the event was already recognized on the product label. 3 Most of these factors are unrelated to the safety of the drug. In addition, FDA public statements, media publicity, and manufacturer warning letters to doctors may increase awareness of particular adverse reactions and increase spontaneous reporting.…”

Section: Commentmentioning

confidence: 99%

“…In the United States, such reports are generally written and submitted by the manufacturer, although reports may be submitted directly to the FDA under the MedWatch Safety Information and Adverse Event Reporting Program. 3 This is the first broad review of adverse event reports about infants and children younger than 2 years of age.…”

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confidence: 99%

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Reported Adverse Drug Events in Infants and Children Under 2 Years of Age

et al. 2002

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ABSTRACT. Objective. To characterize risks to infants and young children from drugs and biological products that were identified in spontaneous adverse event reports submitted to the US Food and Drug Administration.Methods. Of >500 000 MedWatch adverse event reports received by the Food and Drug Administration from November 1997 through December 2000, we identified 7111 reports about infants and children younger than age 2. The reports were analyzed for health outcome (eg, death, hospitalization, congenital anomaly), principal suspect drug, and whether the route of drug exposure was direct administration or through the mother in the perinatal period.Results. Drug therapy was associated with an average of 243 reported deaths annually over the 38-month study period, with 100 (41%) occurring during the first month of life and 204 (84%) during the first year. In 1432 (24%) reported adverse event cases of all levels of severity, exposure to the drug was from the mother during pregnancy, delivery, or lactation. Although 1902 different drugs, biological products, and other chemicals were identified in the reports, only 17 drugs or biological products were a suspect in 54% of all serious and fatal adverse events in drugs administered directly.Conclusion. Adverse reactions to drug therapy are a significant cause of death and injury in infants and children under 2 years of age. Drugs administered to the mother in the perinatal period constituted a major route of exposure to adverse drug advents. These results underscore the need for additional drug testing in the youngest pediatric patients and for carefully weighing the risks versus benefits of medication. Pediatrics 2002; 110(5). URL: http://www.pediatrics.org/cgi/content/full/ 110/5/e53; infant, child, adverse drug reaction reporting systems, drug therapy.

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Section: Commentmentioning

confidence: 94%

Section: Commentmentioning

confidence: 99%

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Reported Adverse Drug Events in Infants and Children Under 2 Years of Age

et al. 2002

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“…For Bhopal, cause is comprised of something that alters the frequency of the disease, health status or associated factors in the population 6 . No definition of the term "cause" was found in didactic materials on pharmacoepidemiology 4,[15][16][17][18][19] . The omission may be related to the difficulty in defining a cause in the context of determining the causality between medication and an adverse event, since, in general, it may involve a mixture of causes, and it is therefore preferable not to speak of "causes", but rather of "risk factors" 15 or "association factors" 18,19 .…”

Section: The Definition Of Causementioning

confidence: 99%

Causalidade em farmacoepidemiologia e farmacovigilância: uma incursão teórica

Mota

Kuchenbecker

2017

Rev. bras. epidemiol.

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ABSTRACT:The article presents some considerations about causality in Pharmacoepidemiology and Pharmacovigilance. To begin, we provide a brief introduction about the importance of the issue, noting that the understanding of causal relationships is considered one of science's greatest achievements and has been, over time, a continuous and central concern of philosophers and epidemiologists. Next, we describe definitions and types of causes, demonstrating their influences on pharmacoepidemiological thought. After that, we present Rothman's multi-causal model as one of the founding explanations of multiple causality and the issue of causality assessment. We conclude with some comments and reflections on causality from the perspective of health surveillance, particularly with regard to regulations on pharmacovigilance.

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“…This passive mechanism of surveillance has been well described (Kennedy et al, 2000). For identification of truly rare or unusual outcomes, this system offers many advantages.…”

Section: Introductionmentioning

confidence: 99%