Pharmacovigilance: When to Report Adverse Reactions to Contrast Media

Part of the Medical Radiology book series (MEDRAD)


The main objective of pharmacovigilance is the early detection of new adverse drug reactions. Health care professionals play a key role in safety surveillance, as they are frontline observers if serious and unexpected adverse effects occur. They are obliged to report their observations and suspicions to the regulatory authorities, thereby enabling the authorities to react in an appropriate and timely manner.


Adverse Drug Reaction Health Care Professional Medicinal Product Nephrogenic Systemic Fibrosis Adverse Drug Reaction Report 


  1. Dukes G (1985) The effects of drug regulation. A survey based on European studies of drug regulation. MTP Press Limited, LancasterCrossRefGoogle Scholar
  2. Finney DJ (1965) The design and logic of a monitor of drug use. J Chronic Dis 18:77–98PubMedCrossRefGoogle Scholar
  3. Grobner T (2006) Gadolinium—a specific trigger for the development of nephrogenic fibrosing dermatopathy and nephrogenic systemic fibrosis? Nephrol Dial Transpl 21:1104–1108CrossRefGoogle Scholar
  4. Lenz W (1966) Malformations caused by drugs in pregnancy. Am J Dis Child 112:99–106PubMedGoogle Scholar
  5. Regulation (EU) no. 1235/2010 amending Regulation (EC) 726/2004 and Directive 2010/84/EU amending Directive 2001/83/ECGoogle Scholar
  6. Stenver DI (2008) Pharmacovigilance: what to do if you see an adverse reaction and the consequences. Eur J Radiol 66:184–186PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2014

Authors and Affiliations

  1. 1.Danish Health and Medicines Authority (DHMA)Department of Drug Safety Surveillance and Medical DevicesKøbenhavn SDenmark

Personalised recommendations