Pharmacovigilance and toxicological risks associated with apitherapeutic products: a systematic overview

The increasing use of bee products in the food, cosmetic, and pharmaceutical industries has intensified interest in their therapeutic properties. However, the safety of these natural compounds warrants careful consideration, particularly within the context of pharmacovigilance. This study aimed to conduct an integrative review of the scientific literature and official pharmacovigilance databases (Notivisa, EudraVigilance, FDA/MedWatch, TGA, among others) to identify adverse effects and toxicological risks associated with the use of honey, apitoxin (bee venom), propolis, royal jelly, bee pollen, and beeswax. The findings indicated that although widely used, these products are not free from risk. Reported cases included infant botulism and grayanotoxin poisoning linked to honey; anaphylaxis and fatalities following therapeutic use of bee venom; contact dermatitis and systemic reactions induced by propolis; severe asthma attacks after royal jelly consumption; adulteration of pollen-based supplements with illicit pharmacological substances; and allergic reactions to beeswax in cosmetic products. Allergic responses were the most prevalent type of adverse event, particularly among atopic individuals. These findings highlight the need for appropriate labeling, post-marketing surveillance, and educational campaigns to ensure the safe use of these products. It is concluded that despite their recognized benefits, apitherapeutic products must be used with caution, and the strengthening of pharmacovigilance systems is essential to safeguard public health.