ISP orders update to tirzepatide brochures due to risk of malnutrition

The Institute of Public Health (ISP) has ordered the sanitary registration holders of pharmaceutical products containing tirzepatide —including Mounjaro— to update the professional and patient information leaflets to warn of the risk of malnutrition. The instruction is contained in exempt resolution No. E4.492, signed on September 3, 2026, by the director of the ISP, Fresia Catterina Ferreccio Readi, and published in the Official Gazette of the Republic of Chile No. 44,566, on Monday, October 5, 2026, under the official reference CVE 2877149.

The resolution is issued within the framework of the ISP’s powers as the national authority for the sanitary control of pharmaceutical products, pursuant to Article 96 of the Sanitary Code and decree with the force of law No. 1 of 2005, from the Ministry of Health. Article 64 of supreme decree No. 3 of 2010 allows the Institute to require, through a reasoned resolution, modifications to the sanitary registration when scientific evidence provides conviction that the authorized conditions of use present a risk to the safety and efficacy of the product.

The text also invokes exempt resolution No. E140 of January 9, 2026, which enables the Pharmacovigilance Sub-department of the National Medicines Agency Department to apply regulatory trust mechanisms, including the instruction to modify information leaflets, labels, and indications.

What the leaflets must incorporate

In the professional information leaflet, holders must add the following information regarding malnutrition in the special warnings and precautions for use, and adverse reactions sections:

• Cases of malnutrition, including severe cases, have been reported in patients treated with tirzepatide.
• Associated risks include vitamin and mineral deficiency, protein deficiency, and low body weight.
• The administration of balanced nutritional support should be considered, and the discontinuation of treatment should be evaluated in severe or persistent cases.

In the patient information leaflet, the text must warn that the medication drastically reduces appetite, which may lead to eating much less than the body needs, causing vitamin and mineral deficiency, protein deficiency, and low body weight. It adds that the doctor may provide guidance on nutrition or recommend vitamins and supplements.

Deadlines and scope of the obligation

Holders must submit the modification of both leaflets for the Institute’s approval within a period not exceeding 90 business days, counted from the date of publication of the resolution. Furthermore, every sanitary registration of a pharmaceutical product containing tirzepatide —or those granted or requested after the publication— must comply with these requirements.

International Precedents

The decision is based on Technical Safety Report No. 24-163, prepared by the Drug and Cosmetic Information and Safety Section of the Sub-department of Pharmacovigilance and Clinical Studies, which concluded that it was necessary to incorporate the risk of malnutrition because it was not communicated in the leaflets despite being documented internationally.

Among the precedents cited in the resolution are:

• The Health Product InfoWatch bulletin, from September 2024, by the Health Canada agency.
• The product monograph for Mounjaro (tirzepatide injection), authorized on June 23, 2026, by Health Canada.
• The Australian Public Assessment Report on Mounjaro, prepared by the Therapeutic Goods Administration (TGA) of Australia, from September 2024.

The instruction obliges the pharmaceutical industry to correct, within a limited timeframe, the information that doctors and patients receive regarding a mass-use drug for type 2 diabetes and weight control. For users, this means that the leaflets must explicitly warn about loss of appetite, malnutrition, and the need for nutritional support, while holders risk observations from the ISP if they do not submit the updated texts within 90 business days.

Source: Official Gazette of the Republic of Chile, No. 44,566, Monday, October 5, 2026, Section I (General Norms), p. 1 (official reference: CVE 2877149).