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Published Online, 23 January 2004, www.theannals.com, DOI 10.1345/aph.1D325.
 The Annals of Pharmacotherapy: Vol. 38, No. 3, pp. 383-388. DOI 10.1345/aph.1D325
© 2004 Harvey Whitney Books Company.
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MEDICATION SAFETY

Adverse Drug Reactions to Anthelmintics

Haleh Bagheri, PharmD PhD

Hospital Practitioner, Department of Pharmacology, Midi-Pyrenees Center of Pharmacovigilance, Faculty of Medicine, Toulouse University Hospital, Toulouse, France

Elise Simiand, PharmD

Resident, Department of Pharmacology, Midi-Pyrenees Center of Pharmacovigilance, Faculty of Medicine, Toulouse University Hospital

Jean-Louis Montastruc, MD PhD

Professor of Pharmacology and Department Head, Department of Pharmacology, Midi-Pyrenees Center of Pharmacovigilance, Faculty of Medicine, Toulouse University Hospital

Jean-François Magnaval, MD PhD

Professor, Department of Parasitology, Faculty of Medicine, Toulouse University Hospital

Reprints: Haleh Bagheri PharmD PhD, Laboratoire de Pharmacologie Médicale et Clinique, Faculté de Médecine, 37 Allées Jules Guesde, BP 7202, 31073 Toulouse Cedex 7, France, fax 33-561-255-116, bagheri{at}cict.fr

BACKGROUND: Anthelmintics are commonly used in tropical areas, but are also prescribed in Western countries with other climates. However, pharmacoepidemiologic studies of these drugs are rare.

OBJECTIVE: To investigate adverse drug reactions (ADRs) due to anthelmintics.

METHODS: All spontaneous reports of ADRs associated with albendazole, diethylcarbamazine, flubendazole, ivermectin, mebendazole, niclosamide, praziquantel, pyrantel pamoate, and thiabendazole were identified in the French Pharmacovigilance Database from January 1, 1985, to August 31, 1999. For each case, the following data were recorded: age, gender, weight, ADRs, drug, dosage, and indication.

RESULTS: A total of 243 cases were found corresponding to 291 ADRs. Serious ADRs (hematologic or hepatic injury) to albendazole most often occurred when the drug was used for the treatment of echinococcosis or cysticercosis, thus requiring both high dosage and long duration of therapy. Our data show that the profile and seriousness of anthelmintic-induced ADRs vary according to their use. Furthermore, the low number of spontaneous reporting of ADRs suggests a high rate of underreporting for these drugs, which are often considered in France as orphan drugs.

CONCLUSIONS: The improvement of reporting of serious or unrecognized (unlabeled) anthelmintic-induced ADRs will increase our knowledge of the benefit/risk ratio associated with these agents and optimize their use.

Key Words: adverse reactions, anthelmintics, pharmacovigilance

Published Online, January 23, 2004. www.theannals.com, DOI 10.1345/aph.1D325




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