Surveillance of suspected adverse reactions to natural health products in Italy.

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.