PAHO and WHO Warn of Risks Associated with Misuse of GLP-1 Medicines

The growing demand for medications like semaglutide and tirzepatide, used in the treatment of type 2 diabetes and obesity, has prompted an epidemiological alert from the Pan American Health Organization (PAHO) and the World Health Organization (WHO). The organizations are warning about the misuse and counterfeiting of glucagon-like peptide-1 (GLP-1) receptor agonists.

What are GLP-1 Receptor Agonists?

GLP-1 receptor agonists – including semaglutide, liraglutide, dulaglutide, and tirzepatide – are medications approved for specific medical uses. Primarily, they are indicated as hypoglycemic therapy for adults with type 2 diabetes, particularly those with cardiovascular disease, chronic kidney disease, or obesity that significantly impacts their health . The WHO included several of these drugs in its Model List of Essential Medicines for type 2 diabetes, with criteria including a body mass index (BMI) of 30 kg/m² or greater when obesity affects quality of life or is linked to other health issues .

Concerns Regarding Misuse and Counterfeiting

PAHO’s alert stems from two key issues: the use of these medications outside of approved medical indications and the increasing prevalence of counterfeit or unauthorized products . These drugs are not intended as cosmetic treatments and require individual clinical evaluation, a structured management plan, and ongoing medical monitoring.

Potential Adverse Effects

While common side effects like nausea, vomiting, and abdominal discomfort are usually temporary, serious adverse events have been reported. These include acute pancreatitis, biliary disease (such as cholelithiasis and cholecystitis), intestinal obstruction, ileus, and gastroparesis. Acute pancreatitis, characterized by severe and persistent abdominal pain accompanied by vomiting, requires immediate medical attention . There is also a warning regarding potential worsening of diabetic retinopathy in patients with long-standing diabetes, necessitating adequate ophthalmological care.

International regulatory bodies are also evaluating potential links to pancreatic cancer or medullary thyroid carcinoma, though a definitive causal relationship has not been established .

Risks of Counterfeit Products

The high demand for GLP-1 medications, fueled by off-label use for weight loss, has led to increased sales through unauthorized channels like social media and e-commerce sites. Products obtained outside the legal supply chain may lack the active ingredient, be contaminated, or have been improperly stored, compromising their safety and effectiveness. Using counterfeit products can lead to adverse reactions and treatment failure in individuals with conditions like type 2 diabetes, increasing the risk of complications .

Recommendations from PAHO

PAHO has urged Member States to strengthen pharmacovigilance systems for monitoring and reporting adverse reactions. They also recommend establishing clear protocols for initiating and discontinuing treatment, and enhancing the traceability of medicines throughout the supply chain . Public awareness campaigns are crucial to inform people that these drugs are not aesthetic products and should only be used for approved indications. Individuals experiencing symptoms like persistent abdominal pain, severe vomiting, or visual disturbances should seek immediate medical attention.

Healthcare professionals are advised to conduct thorough initial evaluations, identify comorbidities, and provide regular clinical and metabolic monitoring. Treatment should be integrated into a comprehensive management plan that includes lifestyle changes and risk factor control.