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Safety of Medicines - A Guide to Detecting and Reporting Adverse Drug Reactions - Why Health Professionals Need to Take Action
(2002; 16 pages)
Table of Contents
View the documentIntroduction
View the documentGlossary
View the documentThe magnitude of the problem
View the documentWhy postmarketing surveillance and reporting ADR is needed
View the documentWhy pharmacovigilance is needed in every country
View the documentHow voluntary reporting on ADRs can prevent new medicine tragedies from developing
View the documentHow voluntary reporting on ADRs can influence labelling
View the documentWhy health professionals are in the best position to detect and report on ADRs
View the documentHow to recognize ADRs
View the documentWhat should be reported?
View the documentHow to report ADRs?
View the documentReferences
View the documentAcknowledgements
 

How voluntary reporting on ADRs can influence labelling

There are many examples of the importance of ADRs reporting in the improvement of information in labelling of many effective pharmaceutical products (new possible ADRs, contraindications, dosage etc.).

Cyclophosphamide has been on the market for several years in many countries. In January 2001 there were some new reactions included in the labels: Stevens Johnson syndrome and toxic epidermal necrolysis; they were not included in the Physician Desk Reference (PDR) 1995.

For example:

EPIDERMAL NECROLYSIS
ERYTHEMA MULTIFORME
STEVENS JOHNSON SYNDROME

Losartan was marketed in the USA since 1995. Some of the new reactions that have been discovered after launch and included in the PDR are:

VASCULITIS
PURPURA ALLERGIC
(incl. HENOCH-SCHOENLEIN PURPURA)
ANAPHYLACTIC SHOCK
ANAPHYLACTOID REACTION

Levofloxacin was launched in the USA in 1997. In February 2000 the label torsade de pointes was included.

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Last updated: May 3, 2013