RETATRUTIDE: REGULATORY CHALLENGES, PATIENT SAFETY, AND THE IMPACT OF THE ILLICIT SALE OF AN INVESTIGATIONAL DRUG FOR THE TREATMENT OF OBESITY

Resumen

Obesity is one of today’s foremost public health challenges, driving the development of new pharmacological therapies for body weight management. This study is a narrative literature review that aimed to analyze the regulatory challenges, patient safety considerations, and impacts arising from the illicit sale of retatrutide, a drug that remains under investigation for the treatment of obesity. The research involved an analysis of scientific articles, documents issued by national and international regulatory agencies, and technical publications addressing the clinical development of retatrutide, its mechanisms of action, preliminary efficacy, safety profile, and the risks associated with its use outside research protocols. The findings showed that, although the drug has yielded promising results in reducing body weight and improving metabolic parameters, obtaining and using it through illicit channels exposes individuals to significant risks, including adverse events that are not yet fully understood, counterfeit products, a lack of quality control, and the absence of professional supervision. In addition, illegal sales hinder the work of regulatory authorities, foster misinformation, and increase the risks associated with self-medication. The study concludes that strengthening health surveillance, health education, and regulatory measures is essential to protect the population until the efficacy and safety of retatrutide have been fully established through scientific evidence.