Pharmacovigilance: what to do if you see an adverse reaction and the consequences.
With outset in a recently identified safety signal--the association between gadolinium and nephrogenic systemic fibrosis--the article highlights the aim of pharmacovigilance and provides an overview of the European regulatory drug safety network. The main objective of the article is to provide appropriate information concerning the regulatory environment to health care professionals working in a clinical setting. The important role played by health care professionals in drug safety surveillance, as well as examples of how the regulatory decision making is functioning in practice, are described and exemplified by means of the gadolinium case.
Stenver
Doris I
DI
Danish Medicines Agency, 1 Axel Heides Gade, DK-2300 Copenhagen S, Denmark. dis@dkma.dk
D016907:Adverse Drug Reaction Reporting Systems; D003287:Contrast Media / Q000009:adverse effects*; D005355:Fibrosis / Q000139:chemically induced; D005682:Gadolinium / Q000009:adverse effects*; D006801:Humans; D007674:Kidney Diseases / Q000139:chemically induced*; D008279:Magnetic Resonance Imaging; D011358:Product Surveillance, Postmarketing; D012871:Skin Diseases / Q000139:chemically induced*
D003287:Contrast Media; D005682:Gadolinium