Ozempic label now notes potential side effect of intestinal blockage

by Miranda Nazzaro - 09/27/23 5:15 PM ET

FILE - A sign in front of the Food and Drug Administration building is seen on Dec. 10, 2020, in Silver Spring, Md. Expedited drug approvals slowed in 2022, as the FDA's controversial accelerated pathway came under new scrutiny from Congress, government watchdogs and some of the agency’s own leaders. With less than a month remaining in the year, the agency’s drug center has granted 10 accelerated approvals — fewer than the tally in each of the last five years, when use of the program reached all-time highs. (AP Photo/Manuel Balce Ceneta, File) — A sign in front of the Food and Drug Administration building is seen on Dec. 10, 2020, in Silver Spring, Md. (AP Photo/Manuel Balce Ceneta)

The U.S. Food and Drug Administration (FDA) updated the label for Ozempic, a type 2 diabetes drug that is often used for weight loss, to now note the potential side effect of intestinal blockage.

In a series of labeling changes for Ozempic, the FDA said the medication will now include a warning of increased reports of ileus, or the blockage of intestinal contents, according to the National Institute of Health.

While the FDA acknowledged reports of adverse reactions from semaglutide, an active ingredient of Ozempic, the regulator did not specifically cite Ozempic or its manufacturer, Novo Nordisk, as the cause of these reports.

“Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a casual relationship to drug exposure,” the FDA wrote in last week’s update.

Weight loss drug Wegovy, which is made by the same manufacturer of Ozempic, also has a warning on reports of ileus on its label.

The change comes less than two months after a Louisiana woman brought a lawsuit against Novo Nordisk and Eli Lily, which manufactures the popular weight loss drug Mounjaro, alleging the drug makers failed to warn patients about the risk of severe gastrointestinal problems.

The lawsuit, filed in August, claims the manufacturers “downplayed the severity of the gastrointestinal events” prompted by their medications, including gastroparesis or stomach paralysis, and gastroenteritis or stomach inflammation.

Both Ozempic and Mounjaro were created to manage blood sugar levels in adults with Type 2 diabetes, but have gained popularity for their off-label use for weight loss.

Novo Nordisk said “patient safety is a top priority,” in a statement shared with The Hill.

“Novo Nordisk stands behind the safety and efficacy of Ozempicand all of our medicines when used consistent with the product labeling and the approved indications,” a spokesperson said.

The Hill has reached out to the FDA for further comment.

—Updated at 5:51 p.m.

Tags fda Food and Drug Administration ozempic