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Nomifensine and hemolytic anemia — experience of a post‐marketing alert
Author(s) -
Stonier Peter D.
Publication year - 1992
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.2630010404
Subject(s) - medicine , nomifensine , medical prescription , postmarketing surveillance , incidence (geometry) , anemia , drug , hemolytic anemia , pharmacoepidemiology , adverse effect , pediatrics , family medicine , psychiatry , pharmacology , physics , dopaminergic , optics , dopamine
The antidepressant nomifensine was withdrawn worldwide by the manufacturer in January 1986 following a rising incidence of reports of acute immune hemolytic anemia with serious clinical sequelae, including a number of fatalities. This short report describes the chronology of events leading up to the drug's withdrawal in one country, the United Kingdom, 9 years after it was first made available. The known incidence of hemolytic anemia reports was related to prescription data and showed that the risk‐benefit ratio was tipped against continued availability of the drug only in the latter part of 1985, shortly before the drug was withdrawn. Factors related to the increased reporting of the adverse events are discussed, but increased awareness by prescribers of drug‐related events and their willingness to report them as a result of medical literature and media reports, including publications by the Committee on Safety of Medicines of Yellow Card data, are thought to have been major contributors.