Pharmacovigilance of Antivenoms in Toxicological Emergencies

Abstract

Antivenoms (AVs) are biological therapies indicated in the treatment of envenoming by bites or stings of venomous animals. However, access, supply problems, quality of manufacturing, sociocultural issues, and regulatory aspects are factors related to the effectiveness and safety of AVs. Likewise, the controlled clinical research is limited apparently for the low prevalence registered in tropical regions such as Latin America, Middle East, Africa, and Asia; therefore, a lack of evidence may elicit an unsuitable approach on the emergency or intensive care units. Moreover, the clinical trials are controversial because they would not reflect the reality inside the clinical setting of envenoming. Accordingly, there are factors influencing the therapeutic response to AVs. Here, the implementation of pharmacovigilance (PV) may help to improve the management of the AVs-related risks through the identification and assessment of suspected drug adverse reactions, ineffecti- veness, and other drug-related problems. Notwithstanding, the knowledge of the PV within clinical toxicology, emergency, and intensive care units is limited. Then, the PV must be established as a routine activity within an integral process of the medical attention of envenoming by bites or stings from venomous animals (BSVA) to guarantee a suitable and safe medication. The aim of this paper is outlining an overview about the clinical setting of envenoming, the current treatment and its relationship with the PV as a complementary activity to improve the quality, effectiveness, safety of AVs, through a perspective of experts in Mexico.