Novo Nordisk, Eli Lilly's weight-loss drugs under FDA scrutiny for suicidal thoughts, hair loss

Use of Novo Nordisk and Eli Lilly’s popular diabetes and weight loss drugs come with warnings about a rare intestinal blockage condition called ileus, which can be life threatening.

Could cautions about more common side effects soon be added to the labels of popular treatments such as Novo’s Ozempic and Lilly’s Mounjaro?

On Tuesday, the FDA revealed that it is investigating patient reports of suicidal thoughts and hair loss from the use of the blood sugar-modulating products. The U.S. regulator also is looking into cases of aspiration, a condition often associated with surgery in which people breathe food, liquids, vomit or saliva into their lungs.

The investigation was triggered by information gathered on the FDA Adverse Event Reporting System (FAERS), a database that allows the regulator to track potential problems by collecting side effect reports from patients and healthcare providers. Each quarter, the FDA posts a list of drugs that it is investigating based on alerts from FAERS.

“The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk,” the FDA wrote. “It means that FDA has identified a potential safety issue, but it does not mean that FDA has identified a causal relationship between the drug and the listed risk.”

The compounds used in Novo and Lilly’s drugs have been on the market for years to treat diabetes. But because of the sudden popularity of the drugs to combat obesity, they have attracted more scrutiny.

In emailed statements, Novo and Lilly said that they work closely with the FDA to monitor the safety of their diabetes and weight loss drugs..

“The known risks associated with use of those medicines are reflected in their current FDA-approved product labeling,” Novo said. “Novo Nordisk stands behind the safety and efficacy of all of our GLP-1RA medicines when they are used as indicated and when they are taken under the care of a licensed healthcare professional.”

In July, the European Medicines Agency began investigating Novo’s Ozempic and Wegovy after reports from Iceland of suicidal thoughts from two users and self-harm from another. An oversight committee will discuss findings in April of this year. Through September of last year, the FDA had received 201 reports of suicidal thoughts from users of Novo’s semaglutide or Lilly’s tirzepatide, the agency said.

The FDA has collected 422 reports of alopecia (hair loss) from users of the drugs and 18 reports of aspiration, as well.

Separately, in August of last year, a 44-year-old Louisiana woman filed a lawsuit against Novo and Lilly, claiming her use of Ozempic and Mounjaro caused severe gastrointestinal issues and led to her teeth falling out.

At the time, Novo pointed out that semaglutide had been examined in clinical development programs and “large real world evidence studies with more than 9.5 million patient years of exposure.”