FDA asks for removal of suicide warnings on GLP-1 drugs

The Food and Drug Administration on Tuesday told Eli Lilly and Novo Nordisk to remove warnings about the risk of suicidal thoughts and behavior from the labels of their blockbuster GLP-1 weight-loss drugs.

Why it matters: The action caps more than a year of studies into reported side effects in people taking the injectable drugs. It covers Novo Nordisk's Saxenda and Wegovy and Lilly's Zepbound.

• Some research has focused on patients with psychiatric disorders, since certain antipsychotics or antidepressants are associated with weight gain and could make the patients possible candidates for GLP-1 treatment.

Driving the news: Regulators said a comprehensive review found no increased risk of suicidal ideation or behavior associated with the use of GLP-1s.

• At the time of the original FDA approvals, the labeling for the weight-loss products included information about such risks based on reports of events observed with older medicines used or studied for weight loss.
• Labels have said suicidal behavior or thoughts have been reported in clinical trials for other weight-loss products and recommend that doctors monitor patients for unusual changes in mood or behavior.
• Novo Nordisk's Ozempic and other drugs approved as diabetes treatments don't include similar labeling language.

"Today's FDA action will ensure consistent messaging across the labeling for all FDA approved GLP-1 RA medications," the agency said.