The news: The FDA asked GLP-1 drugmakers Novo Nordisk and Eli Lilly to remove suicide risk warnings from their weight loss medications.

The FDA initially required suicidal ideation warnings for Wegovy and Zepbound as a precaution, despite a lack of causal evidence. Regulators mandated these labels at launch because long-term data was insufficient to rule out risks. Even in 2024, the Biden-era FDA noted that while no link was found, they could not definitively prove that a small risk did not exist.

A comprehensive data review confirmed GLP-1s present no increased risk of suicide, leading the FDA to request the withdrawal of the warnings. After analyzing 91 trials and over 100,000 patients, the latest FDA review found no causal link to suicidal ideation or behavior.

Why it matters: The suicide risk warning on GLP-1s was a psychological signal to parents, prescribers, and payers. Its removal normalizes the drugs’ labels, casting GLP-1s as safe options for interested patients.

• About one in five (18%) US adults have tried a GLP-1 drug for weight loss or health reasons, but another 22% who’ve never taken them are interested in trying for weight loss, per KFF survey data in November.
• Among US adults who have been diagnosed as overweight or obese in the past five years, it jumps to 43% who are interested in weight loss drugs, per KFF.

Implications for pharma marketers and consumers: The removal of suicide warnings helps pharma marketers position GLP-1 therapies as safe, mainstream therapies for chronic conditions, just as new oral options are expected expand the market. Novo Nordisk debuted the Wegovy pill last month, and Eli Lilly's is expected to be approved in April. For consumers, the change may reduce stigma and hesitation, especially for younger and first-time users, making it easier to start and stay on treatment.

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