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FDA Updates Ozempic Label With Warning for Intestinal Blockages

The FDA is cautioning people that the diabetes medication Ozempic – commonly prescribed off-label for weight loss – may be linked to a rare but severe side effect.

After multiple reports of intestinal blockages following Ozempic use, the US Food and Drug Administration (FDA) has added a new warning to the drug’s label.

Ozempic (semaglutide) is a GLP-1 agonist used to regulate blood sugar in people with type 2 diabetes. Demand for the drug has skyrocketed in recent years due to its effectiveness for weight loss, although it’s not yet FDA-approved for that purpose. 

Many Ozempic users are already familiar with the gastrointestinal side effects of the drug – including diarrhea, nausea, vomiting, and stomach pain. Now a new, potentially life-threatening adverse reaction has been added to the list.

Known medically as ileus (blocked intestines), this gastrointestinal problem occurs when the intestines can’t properly contract and move waste through the body. Roughly 20 cases of ileus – including two deaths – have been reported after Ozempic use. 

Ileus is typically a result of abdominal surgery, but can also be caused by inflammation, injuries, and certain medications. Signs of an intestinal blockage include bloating, abdominal cramps, constipation, nausea, and vomiting.

While a warning has been added to Ozempic’s drug label, the FDA hasn’t cited a direct link between semaglutide and ileus – a rare, but serious side effect.

Do other diabetes drugs carry this warning? 

Warnings for intestinal blockages already exist for other popular diabetes drugs including Wegovy and Mounjaro (tirzepatide). Both Ozempic and Wegovy are forms of semaglutide used to treat type 2 diabetes, but only Wegovy is FDA-approved for weight loss in people with overweight or obesity. 

New to the market is Mounjaro, a unique GIP and GLP-1 combination medication approved for type 2 diabetes used in conjunction with healthy eating patterns and exercise. Though not yet approved for overweight or obesity, Mounjaro’s manufacturer Eli Lilly is seeking FDA approval for weight management due to the drug’s remarkable effects on weight loss.

Are there other gastrointestinal concerns with Ozempic? 

There have also been reports of stomach paralysis, a condition known as gastroparesis (delayed stomach emptying), potentially related to Ozempic, though these claims have yet to be substantiated. Ozempic works by reducing appetite and slowing down how fast the stomach empties. While a link between Ozempic and stomach paralysis has not been established yet, GLP-1s are not recommended for people who already have gastroparesis. 

If you’re taking a GLP-1 and experience symptoms like constipation that don’t subside within a few days, consult with a healthcare provider.

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