Pharmacovigilance: What to do if you see an adverse reaction and the consequences

Stenver, Doris I.

doi:10.1016/j.ejrad.2008.02.009

Cited by 25 publications

(29 citation statements)

References 2 publications

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“…In 1998, Danish contra-indications for gadodiamide administration to CKD patients were revoked in 1998. 37,47,48 Gadodiamide use rapidly expanded in the late 1990s due to favorable comparisons versus iodine-containing contrast media and its regulatory approval in several countries for use at higher doses (0.3 mmol/kg dosing) for brain and/or general MRI scans. Worldwide, 40 million gadodiamide doses have been administered since 1993.…”

Section: Nephrogenic Systemic Fibrosismentioning

confidence: 99%

Linking Drugs to Obscure Illnesses: Lessons from Pure Red Cell Aplasia, Nephrogenic Systemic Fibrosis, and Reye’s Syndrome. A Report From the Southern Network on Adverse Reactions (SONAR)

et al. 2012

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Identification of serious adverse drug reactions (sADRS) associated with commonly used drugs can elude detection for years. Reye’s syndrome (RS), nephrogenic systemic fibrosis (NSF), and pure red cell aplasia (PRCA) among chronic kidney disease (CKD) patients were recognized in 1951, 2000, and 1998, respectively. Reports associating these syndromes with aspirin, gadodiamide, and epoetin, were published 29, 6, and 4 years later, respectively. We obtained primary information from clinicians who identified causes of these sADRs and reviewed factors contributing to delayed identification of these toxicities. Overall, 3,500 aspirin-associated RS cases in the United States, 1,605 gadolinium-associated NSF cases, and 181 epoetin-associated PRCA cases were reported. Delays in FDA regulation of over-the- counter medications and administration of aspirin to children contributed to development of RS. For NSF, in 1996, the Danish Medicine Agency approved high-dose gadodiamide administration to chronic kidney disease (CKD) patients undergoing MR scans. Overall, 88 % of Danish NSF cases were from two hospitals and 97 % of United States’ NSF cases were from 60 hospitals. These hospitals frequently administered high-doses of gadodiamide to CKD patients. Another factor was the decision to administer linear chelated contrast agents versus lower risk macrocyclic chelated agents. For PRCA, increased use of subcutaneous epoetin formulations to CKD patients, in part due to convenience and cost-savings considerations, and a European regulatory requirement requiring removal of albumin as a stabilizer, led to toxicity. Overall, 81, 13, and 17 years elapsed between drug introduction into practice and identification of a causal relationship for aspirin, erythropoietin, and gadodiamide, respectively. A substantial decline in new cases of these sADRs occurred within two years of identification of the offending drug. Clinicians should be vigilant for sADRs, even for frequently-prescribed pharmaceuticals, particularly in settings where formulation or regulatory changes have occurred, or when over-the-counter, off-label, or pediatric use is common

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Section: Nephrogenic Systemic Fibrosismentioning

confidence: 99%

Linking Drugs to Obscure Illnesses: Lessons from Pure Red Cell Aplasia, Nephrogenic Systemic Fibrosis, and Reye’s Syndrome. A Report From the Southern Network on Adverse Reactions (SONAR)

et al. 2012

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“…A notificação dos casos identificados ou que vieram a conhecer por meio do relato de consumidores é de caráter obrigatório pelo fabricante de medicamentos veterinários, em um prazo de até 15 dias caso o evento notificado seja inesperado, ou caso haja um aumento inesperado na incidência ou severidade de um evento esperado (Bukowski e Wartenberg, 1996;Bataller e Keler, 1999;Woodward, 2005b). Além disso, por meio do sistema PSUR (Periodic Safety Update Report) o fabricante deve encaminhar ao CVM a cada seis meses, durante o primeiro ano após aprovação de autorização de mercado, e após este período anualmente, dados sobre a segurança dos medicamentos veterinários (Woodward, 2005b;Stenver, 2008). As notificações de reações adversas a medicamentos (RAM) são analisadas por veterinários, podendo envolver também avaliação pelo Monitored Adverse Reaction Committee (MARC).…”

Section: Estados Unidos Da Américaunclassified

“…Consolida-se, portanto a Farmacovigilância como atividade no campo da Saúde Pública (Dainesi, 2005;Akici e Oktay, 2007;Stenver, 2008).…”

Section: Introductionunclassified

Farmacovigilância Veterinária E a Saúde Humana: Uma Revisão Dos Programas Selecionados De Notificação De Eventos Adversos a Medicamentos Veterinários

Fusco

Oliveira²,

Pepe³

2010

AVS

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VETERINARY PHARMACOVIGILANCE AND THE HUMAN HEALTH: A REVIEW OF SELECTED ADVERSE VETERINARY DRUG REACTION REPORTING PROGRAMSABSTRACT: Drug safety profile is an important theme throughout the world. Recently, it has gained importance in the field of veterinary medicines. In Brazil, Ministry of Agriculture Law SDA 152/2008 submitted to the public consultation the draft of a National Program of Veterinary Pharmacovigilance. Taking into consideration the health risk to exposed human beings, the objectives of this paper are: characterization of veterinary pharmacovigilance and its usefulness for the Public Health, the description of established veterinary pharmacovigilance programs from the United States of America, the European Union and the United Kingdom, and the analysis of the Brazilian Program of veterinary pharmacovigilance draft.

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“…It is important to be aware that drug safety surveillance is necessary for the entire life cycle of drugs, beginning in the pre-marketing phase and continuing throughout the postmarketing period. The condition nephrogenic systemic fibrosis (NSF) associated with the administration of gadolinium-based MR contrast agents to patients with renal impairment underlines this fact (Stenver 2008). Occasionally, it is necessary to monitor safety after marketing has ceased, for example, in the case of suspected late-onset adverse events, or to gather information on the outcome of observed events.…”

Section: Introductionmentioning

confidence: 98%

Pharmacovigilance: When to Report Adverse Reactions to Contrast Media

Stenver¹

2014

Medical Radiology

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Pharmacovigilance: What to do if you see an adverse reaction and the consequences

Cited by 25 publications

References 2 publications

Linking Drugs to Obscure Illnesses: Lessons from Pure Red Cell Aplasia, Nephrogenic Systemic Fibrosis, and Reye’s Syndrome. A Report From the Southern Network on Adverse Reactions (SONAR)

Linking Drugs to Obscure Illnesses: Lessons from Pure Red Cell Aplasia, Nephrogenic Systemic Fibrosis, and Reye’s Syndrome. A Report From the Southern Network on Adverse Reactions (SONAR)

Farmacovigilância Veterinária E a Saúde Humana: Uma Revisão Dos Programas Selecionados De Notificação De Eventos Adversos a Medicamentos Veterinários

Pharmacovigilance: When to Report Adverse Reactions to Contrast Media

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