Surveillance of suspected adverse reactions to natural health products in Italy

Abstract

Purpose Natural health products are promoted to the public as equally or more effective and less toxic than conventional drugs. However, some 'natural' medicines, and in particular some herbal medicines, are known to have adverse effects. The Italian Pharmacovigilance System, in charge of the Italian Medicines Agency, collects spontaneous reports only for registered drugs. The awareness of the need of surveillance of the safety of natural health products has stimulated the implementation of a suspected adverse reaction reporting system in Italy. The system has been set up by the Italian National Institute of Health. Methods An ad hoc reporting form can be downloaded from different institutional web sites. Voluntary reports of suspected adverse reactions are sent to the National Institute of Health and are evaluated by a multidisciplinary group of experts. Results From April 2002 to March 2007, 233 spontaneous reports of suspected adverse reactions to natural health products were collected. A large proportion of suspected adverse reactions were serious: hospitalization was reported in 35% of forms; 6% reported life threatening clinical events and two fatal events were notified. About 50% of suspected adverse reactions were related to gastrointestinal, skin, psychiatric and nervous system disorders. Mainly herbal products (66%) were involved. Twenty-one cases of hepatitis of various seriousness were reported. Twenty-one reports were associated with 27 homeopathic preparations, mostly preparations containing mixtures of substances. Fourteen reports regarded suspected reactions to products containing propolis. Conclusion Safety and efficacy of 'natural' medicines have not been thoroughly investigated. It is important to improve communication with the public on safety issues. Encouraging spontaneous reporting can contribute to improve awareness among health personnel and patients about the benefit-harm profile of these remedies. Copyright (C) 2008 John Wiley & Sons, Ltd

Adverse Effects of Plant Food Supplements and Plants Consumed as Food: Results from the Poisons Centres-Based PlantLIBRA Study

“…This study analyzed two situations in which plant material was ingested: on the one hand the ingestion of a plant in form of a preparation (PFS) with the purpose to maintain health, and on the other, the consumption of a plant as food. Between these two situations there were considerable differences concerning the involved plants and, accordingly, the observed signs and In this study gastrointestinal and neurological symptoms were the clinical effects most frequently observed, which is in accordance with data from the Italian pharmacovigilance centre on spontaneously reported adverse effects related to natural health products (including homeopathics) (Menniti-Ippolito, 2008). Data on complementary medicines from pharmacovigilance centres in Sweden and Singapore showed different results.…”

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Nutraceuticals: opening the debate for a regulatory framework

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Allergy-Like Immediate Reactions with Herbal Medicines: A Retrospective Study Using Data from VigiBase®

“…Although there are many case reports of ADR associated with herbals in the literature, the majority of reports are documented in large pharmacovigilance databases, and those valuable resources should be systematically analyzed for ADR associated with herbals [7,11,12]. ADR to herbals cover a wide range of manifestations that are mostly mild and followed by full recovery.…”