Safety profile assessment of buflomedil: an overview of adverse reactions between 1975 and 2011
Version of Record online: 31 JUL 2012
Copyright © 2012 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 21, Issue 11, pages 1190–1196, November 2012
How to Cite
Bucolo, C., Longo, L., Camillieri, G., Drago, F. and Salomone, S. (2012), Safety profile assessment of buflomedil: an overview of adverse reactions between 1975 and 2011. Pharmacoepidem. Drug Safe., 21: 1190–1196. doi: 10.1002/pds.3328
- Issue online: 29 OCT 2012
- Version of Record online: 31 JUL 2012
- Manuscript Accepted: 5 JUL 2012
- Manuscript Revised: 10 MAY 2012
- Manuscript Received: 19 DEC 2011
- adverse drug reaction;
- post-marketing surveillance;
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.
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.
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.
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.