In a consequential development for the pharmaceutical industry and consumers alike, the Food and Drug Administration (FDA) has approved label modifications for the diabetes drug Ozempic, acknowledging reports of blocked intestines, or ileus, in users of the medication.

Manufactured by Danish pharmaceutical company Novo Nordisk, Ozempic has gained widespread attention not only as a diabetes medication but also as an off-label drug for weight loss.

The updated label joins a growing list of medications in the burgeoning GLP-1 agonist class that also come with warnings about reports of ileus.

It is not just Ozempic bearing this caution; Wegovy, another weight-loss drug and injection of semaglutide also manufactured by Novo Nordisk, and Mounjaro, a diabetes medication from Eli Lilly, have similar acknowledgments.

Yet the FDA’s acknowledgment stops short of establishing a definitive causality between the drug and the condition.

The label explicitly states: “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 causal relationship to drug exposure.”

Data from the FDA reveals the agency has received 8,571 reports of gastrointestinal disorders after the use of semaglutide medications, which include both Ozempic and Wegovy, up to June 30.

Ileus is cited in 33 of these cases and includes two deaths. The data raises urgent questions about the drugs’ long-term safety implications, particularly as they become more widely adopted for both their approved and off-label uses.

Adding another layer to the issue, both Novo Nordisk and Eli Lilly are facing legal challenges over claims that their medications can also induce a condition known as gastroparesis or paralysis of the stomach.

Gastroparesis, unlike ileus, prevents food from reaching the small intestine without a physical blockage.

“Although there is some overlap in the terms, ileus and gastroparesis, they are not synonymous,” noted FDA spokesperson Chanapa Tantibanchachai, who also indicated that the FDA continues to monitor “reports of gastroparesis and other related terms” in real-world use of these medications.

In a statement released on Thursday, Novo Nordisk affirmed its commitment to working with the FDA “to continuously monitor the safety profile of our medicines.”

The drugmaker also underlined that they stand “behind the safety and efficacy of Ozempic and all of our medicines when used consistent with the product labeling and the approved indications.”

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