Document Detail

Safety profile assessment of buflomedil: an overview of adverse reactions between 1975 and 2011.
MedLine Citation:
PMID:  22855302     Owner:  NLM     Status:  Publisher    
PURPOSE: Review all the individualized cases of adverse drug reaction (ADR) potentially related to buflomedil, a vasodilator with the indication for peripheral arterial disease (PAD), marketed in Europe since the 1970s but recently suspended by the European Medicines Agency. METHODS: A review of all available individualised case safety data relating to oral buflomedil from the buflomedil global safety database (provided by the manufacturer of buflomedil), the worldwide published medical literature, toxicology/poison centres and regulatory authorities. RESULTS: The main ADRs reported were in the cardiovascular (CVS) and nervous systems (NS), grouped under four (MedDRA) System Organ Classes (SOCs): (i) Cardiac disorders; (ii) Vascular disorders; (iii) Investigations; (iv) NS disorders. From an initial cumulative number of 1054 case reports, there were 401 cases of intentional overdose (IOD) of which 63 were fatal, and 137 cases of accidental overdose, with two fatalities, and 516 case reports of ADRs under normal conditions of use of the product at normal therapeutic dosage with 11 fatalities. Overdosage (intentional or accidental) represented 50.9% of cases, with 47.6% of patients <40 years of age. The indications for which these young patients were prescribed buflomedil were not reported in most cases. CONCLUSIONS: The main indication of buflomedil is PAD; however, because most cases of IOD occurred in people <40 years of age, where PAD is unlikely, it is possible that buflomedil was prescribed for other indications and/or that it was not directly prescribed to the end user, who rather gained access to the medication prescribed to family members or friends. Copyright © 2012 John Wiley & Sons, Ltd.
Claudio Bucolo; Laura Longo; Giovanni Camillieri; Filippo Drago; Salvatore Salomone
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-7-31
Journal Detail:
Title:  Pharmacoepidemiology and drug safety     Volume:  -     ISSN:  1099-1557     ISO Abbreviation:  Pharmacoepidemiol Drug Saf     Publication Date:  2012 Jul 
Date Detail:
Created Date:  2012-8-2     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9208369     Medline TA:  Pharmacoepidemiol Drug Saf     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012 John Wiley & Sons, Ltd.
Department of Clinical and Molecular Biomedicine, Section of Pharmacology and Biochemistry, University of Catania, Italy.
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