Featured repression

Anvisa Bans the Sale of Tirzepatide and Retatrutide Injectable Pens and Orders Their Recall

Anvisa bans and recalls tirzepatide and retatrutide pens sold without health registration in Brazil

The Brazilian Health Regulatory Agency (Anvisa) ordered the seizure and banned the sale of tirzepatide- and retatrutide-based products that were being offered in Brazil without registration or health approval. The measure was published on Wednesday (Oct. 14) and applies to various products advertised primarily online.

According to the agency, the decision was made because these items were available to consumers without proof of quality, safety, and efficacy. For this reason, the products affected by the order may not be manufactured, imported, distributed, sold, advertised, or used in the country.

The inspection identified products in vials and pens containing these substances. Among the products cited by Anvisa are 120-mg versions of retatrutide, 60-mg retatrutide pens, 150-mg tirzepatide, and 75-mg tirzepatide pens, as well as other peptides and injectable products sold illegally.

The ruling covers products advertised on the websites Peptídeos do Brasil, Oxygen KWP Pharma Brasil, and ZPHC Store, as well as other websites identified during the inspection. In some cases, Anvisa also noted that the products were attributed to companies of unknown origin or without proper authorization to manufacture medications.

It is important to note that the decision does not constitute a general ban on tirzepatide in Brazil. A product containing this active ingredient is duly registered in the country. Mounjaro, manufactured by Eli Lilly, was initially approved by Anvisa to aid in glycemic control in people with type 2 diabetes and, subsequently, had its indication expanded to include chronic weight management in certain patients, in combination with a low-calorie diet and increased physical activity.

For weight management, the indication approved by Anvisa covers adults with a BMI of 30 kg/m² or higher, or individuals with a BMI of 27 kg/m² or higher who have at least one condition associated with excess weight, such as hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, prediabetes, or type 2 diabetes.

Tirzepatide acts as an agonist of the GIP and GLP-1 receptors. Its effects include improved insulin response, glucose-dependent reduction in glucagon levels, delayed gastric emptying, and reduced food intake, contributing to a greater sense of satiety and appetite control.

The situation with retatrutide, however, is different. According to Anvisa, the substance sold illegally online does not yet have health registration in any country in the world. The agency reported that the company responsible for the drug’s clinical trials had not yet applied for registration with Anvisa or other international regulatory authorities as of the publication of the measure.

Therefore, products advertised as retatrutida should not be confused with drugs that have already been evaluated and registered by health authorities. The lack of registration means that these marketed products have not undergone the necessary regulatory process to verify aspects such as composition, origin, quality, safety, and efficacy for use by the general public.

In the case of duly registered drugs that act on the GLP-1 system, such as Mounjaro, their sale in Brazil is subject to a prescription requirement—a rule adopted by Anvisa for products in this class. Thus, the determination published now focuses on unlicensed or unregulated products, and not on drugs that are duly registered and marketed in accordance with Brazilian health regulations.

Source: Anvisa proíbe venda e determina recolhimento de canetas de tirzepatida e retatrutida