US to add vision loss risk warning to Ozempic and Wegovy labels

This is a translation of the original article in Portuguese. Read the original (Português).

The FDA, the United States drug regulator, will add a warning about the risk of vision loss to the labels of medications such as Ozempic and Wegovy. The information comes from the newspaper Jornal de Notícias, the Portuguese daily, in a report on the decision.

According to the newspaper, the agency reached the measure after examining more than 125 clinical trials. A label warning is the tool through which the regulator informs patients and health professionals about risks associated with a medication.

Ozempic and Wegovy belong to the group of drugs that have become popular in Brazil as so-called weight-loss pens. For that reason, a safety change set in the United States draws attention from people who already use this type of treatment and from those considering starting it.

In practice, the warning means the risk of vision loss will formally appear in the package insert and labeling of the products sold in the American market. Adding a warning does not, in itself, mean the drugs are being withdrawn from circulation.

So far, the report does not include guidance from Anvisa, Brazil’s health regulatory agency, or from Brazilian medical organizations on the subject. There is also no information on whether the Brazilian agency intends to change the package inserts sold in the country. It is up to Anvisa, which regulates medicines in Brazil, to decide whether it will adopt a similar measure, and the agency has yet to detail any possible procedures.

For people who already use these medications, the American decision reinforces the importance of medical follow-up during treatment. Changes in vision should be reported to the health professional who prescribed the drug, and the medication should not be suspended or switched on one’s own.

The topic reaches the Brazilian public at a time of heightened attention to the safety of this type of product, which has gained space in pharmacies and in conversations about health and aesthetics. The FDA decision is likely to fuel the debate over the care needed when using these pens, which are sold by prescription.

Reporting from Jornal de Notícias (p. 28, editoria Estados Unidos: Medicamentos para emagrecer com alerta para perda de visão).