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man sitting on couch holding an ozempic injector pen

The U.S. Food and Drug Administration (FDA) has been looking into the potential side effects of diabetes and weight-loss drugs Ozempic and Wegovy, including suicidal ideation. The administration noticed potential signals of the serious risk in the FDA Adverse Event Reporting System (FAERS), which contains data on medication problems reported to the FDA.

New research shows no link between these medications and suicidal ideation. Yet the FDA stated it can’t yet rule out a possible small increased risk.

Meanwhile, previous research does show that the medications may cause other potential side effects—including gallbladder disease, gastroparesis (stomach paralysis), and slowed stomach emptying.

What Are Ozempic and Wegovy?

Both Ozempic and Wegovy contain the active ingredient semaglutide, which belongs to a class of drugs called GLP-1 agonists. GLP-1 is produced in the small intestine, and has several roles in the digestive process, including helping to delay the emptying of the stomach.

GLP-1 agonists like semaglutide act on the intestinal wall to slow the muscle contractions that would normally push food along. More food remains in the digestive system, making patients feel full longer—and possibly inspiring them to eat less. Semaglutide also stimulates insulin secretion, which is why it is approved to treat type II diabetes.

The FDA first cleared Ozempic to be sold on the market in 2017, and has approved several other variations of semaglutide since then. Wegovy was approved in 2021 to treat obesity in overweight in certain patients.

FDA Can’t Rule Out a Potential Connection Between Ozempic and Suicidal Ideation

On January 11, 2024, the FDA published an update on their research into suicidal thoughts or actions in patients treated with GLP-1 agonists. They noted that, so far, they have “not found evidence that use of these medicines causes suicidal thoughts or actions.”

Over the past several months, investigators have gone through the reports they received of suicidal thoughts or actions in patients. They noted that the information provided was often limited, and that so far, they can see no clear relationship between these side effects and the medications. They noted, however, that they cannot rule out a possible connection:

“However, because of the small number of suicidal thoughts or actions observed in both people using GLP-1 Ras [receptor agonists] and in the comparative control groups, the FDA cannot definitively rule out that a small risk may exist; therefore, the FDA is continuing to look into this issue.”

The FDA recommended that patients talk to their health care providers about any related concerns.

European regulators have been looking into a possible link between GLP-1 agonists and suicidal thoughts for months, but so far have not drawn any conclusions. A recently published study in Nature Medicine in which scientists reviewed electronic health records from the TriNetX Analytics Network showed that semaglutide was associated with a lower risk for suicidal ideation than other anti-obesity medications.

Ozempic and Wegovy Linked to Several Side Effects

Soon after these drugs were released, the FDA started receiving reports of side effects related to them. Studies then showed that patients taking them had a significantly higher risk of gallstones. Manufacturer Novo Nordisk modified the Ozempic label in 2022 to include a warning about that.

As early as 2020, published studies warned that GLP-1 agonists could exacerbate existing symptoms of diabetic gastroparesis. Case studies indicated that some patients taking weekly injections suffered gastroparesis, then improved once they stopped taking the medication.

Meanwhile, several patients have filed lawsuits against Novo Nordisk for failing to warn of serious digestive issues like stomach paralysis. A motion has been filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate these cases in one court for pre-trial proceedings.

In a January 2024 quarterly report by the FDA, administrators indicated that the FDA was looking into reports that these drugs were related to increased thoughts of suicide in patients. They also noted they were investigating additional potential side effects like hair loss.

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