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01-08-2004 | Review Article

Safety of Calcium Dobesilate in Chronic Venous Disease, Diabetic Retinopathy and Haemorrhoids

Authors: Professor Hervé Allain, Albert A. Ramelet, Elisabeth Polard, Dani`ele Bentué-Ferrer

Published in: Drug Safety | Issue 9/2004

Abstract

The aim of the present review is to consider the adverse effects and the safety profile of calcium dobesilate. Calcium dobesilate (Doxium™) is a veno-tonic drug, which is widely prescribed in more than 60 countries from Europe, Latin America, Asia and the Middle East for three main indications: chronic venous disease, diabetic retinopathy and the symptoms of haemorrhoidal attack.

Data sources used for this review comprise the international literature (1970–2003), a postmarketing surveillance (PMS) report for calcium dobesilate from OM Pharma (Geneva, Switzerland) covering the period 1974–1998, and periodic safety update reports (PSUR) covering the period 1995–2003 from the French Regulatory authorities pharmacovigilance database and OM Pharma. Data from the PMS report for 1974–1998 indicated that adverse events with calcium dobesilate did not occur very frequently and had the following distribution in terms of frequency: fever (26%), gastrointestinal disorders (12.5%), skin reactions (8.2%), arthralgia (4.3%), and agranulocytosis (4.3%). No deaths were attributed to calcium dobesilate in the PMS report. Using data on product use in the Swiss Compendium we estimated the prevalence of agranulocytosis to be 0.32 cases/million treated patients, i.e. ten times less than the calculated prevalence of agranulocytosis in the general population. Most adverse events are type B, i.e. rare and unrelated to the pharmacological properties of calcium dobesilate.

This review concludes that the risk of an adverse effect with calcium dobesilate 500–1500 mg/day is low and constant over time. The recently raised problem of agranulocytosis (a total of 13 known cases drawn from all data sources) appears to be related to methodological bias. Such a review reinforces the need for a strong international pharmacovigilance organisation using similar methods to detect and analyse the adverse effects of drugs.

The use of trade names is for identification purposes only and does not imply endorsement.

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Title: Safety of Calcium Dobesilate in Chronic Venous Disease, Diabetic Retinopathy and Haemorrhoids
Authors: Professor Hervé Allain
Albert A. Ramelet
Elisabeth Polard
Dani`ele Bentué-Ferrer
Publication date: 01-08-2004
Publisher: Springer International Publishing
Published in: Drug Safety / Issue 9/2004
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI: https://doi.org/10.2165/00002018-200427090-00003

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Safety of Calcium Dobesilate in Chronic Venous Disease, Diabetic Retinopathy and Haemorrhoids

Abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

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