Should Ozempic Include a Warning About Mental Health Side Effects?


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Semaglutide is the active ingredient in both Ozempic and Wegovy, yet only one of the two prescription drugs currently lists mental health side effects on its label. Cavan Images/Getty Images
  • Ozempic does not list anxiety, depression, or suicidal thoughts on its label, yet Wegovy’s label does.
  • The active ingredient in both Ozempic and Wegovy is semaglutide, which is a glucagon-like peptide-1 (GLP-1) receptor agonist.
  • If you feel like your mental health has changed while taking a GLP-1 like Ozempic or Wegovy, contact your doctor immediately.

While many people are in the know when it comes to Ozempic and Wegovy, they may not know the difference regarding the possible mental health side effects of these medications.

Wegovy’s label lists adverse mental health side effects, yet Ozempic’s label does not. But both drugs contain semaglutide, which, according to Wegovy’s warning label, could raise the risk of:

  • anxiety
  • depression
  • suicidal ideation and attempt

According to Dr. Sethu Reddy, president of the American Association of Clinical Endocrinology, there’s a valid reason. “It’s not that the FDA or [drug company] are lying to the public or hiding stuff,” he told Healthline.

Reddy explained that when drug companies conduct clinical trials to get FDA approval, they must collect and report all adverse events that occur more in patients receiving the drug than those in the placebo group.

Still, mental health side effects should not be omitted or minimized, noted Dr. Raafat Girgis, psychiatrist and clinical director at Moment of Clarity. “The consumer should always maintain the right to know the consequences as well as the benefits of using any medication or product,” Girgis told Healthline.

Does semaglutide cause mental health issues?

The active ingredient in Ozempic and Wegovy is semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist.

Semaglutide mimics the GLP-1 hormone that is released in the gastrointestinal tract in response to eating. GLP-1s prompt the body to produce more insulin, which reduces blood sugar. This is why Ozempic is given for diabetes.

Additionally, GLP-1s in higher amounts also interact with the parts of the brain that reduce appetite and signal a feeling of fullness. This is howthe active ingredient in Wegovy helps people lose weight.

Higher amounts of semaglutide in Wegovy compared to Ozempic could be why more adverse mental health effects were reported in clinical trials for Wegovy, Reddy said

“When [medications] try to shut off your appetite, a number of other things happen in the brain as well, from depression to anxiety,” he said. “You probably see less of those effects with the GLP-1s like semaglutide, but nevertheless, with medications that have an effect on the brain, you should always look out for any central nervous side effects.”

Reddy noted that the psychological and mental state of patients taking Wegovy for weight loss versus patients taking Ozempic for diabetes management may also factor into mental health.

“Mental health is obviously very important for weight management because when you think of all the mental health factors that make people eat — stress from bad or joyful things tends to stimulate people to eat, anxiety is a big part of it, social attitudes toward weight gain, coping mechanism for emotional and physical abuse,” Reddy said.

Girgis added that common side effects of Ozempic and Wegovy may trigger mental health side effects. These include:

  • nausea
  • vomiting
  • constipation
  • diarrhea

“I think the worst side effect is the gastrointestinal effects of the injection,” Girgis said.

“When the body is not able to release waste in a normal fashion, it will reject the reaction and attempt to regulate itself, causing confusion in your natural state of functioning. The mental aspect of worry and anxiety can worsen how your body reacts to the procedure.”

Dehydration caused by gastrointestinal effects can also affect mental health, Girgis noted.

What to do if semaglutide affects your mental health

If you feel like your mental health has changed while taking a GLP-1 like Ozempic or Wegovy, contact your doctor immediately.

“If they are not reachable, head to the emergency room or urgent care,” said Girgis.

Rest assured that there are alternative medications and treatment options for diabetes and weight loss. Most often, doctors will initially reduce the dosage to see if it helps ease mental health effects.

“Any medication has what we call a therapeutic window, so if you take too much aspirin, it’s going to cause a gastric ulcer or bleeding, and so on. The doctor will try to find what is the dosage where it’s effective, but not causing the side effects,” Reddy said.

After a trial and error, they might stop the medication for a few weeks to see if mental health improves and then you restart the medication.

“If the moods change again, then you have your answer and we’ll typically try a lower dose or try a different medication,” said Reddy.

How do hormones affect you mentally?

The type of hormone, the purpose it is used for, and the gender of a person all factor into whether hormones may induce mental health effects.

For instance, Reddy said insulin is a hormone that, when taken in appropriate amounts, does not cause changes in mental health.

Other hormones like testosterone and estrogen are circumstantial.

For example, Girgis said testosterone can cause several mental health issues, such as rage, agitation, and aggressive response.

However, Reddy noted that when given to men who have low testosterone, it may improve their outlook on life, energy, and exercise tolerance.

If a woman is going through menopause and having mental health changes, sometimes depression and anxiety improve when she takes oral estrogen, said Reddy.

Girgis said, “it is important to know and be aware that depression, mood swings, anxiety, and sadness can happen at any time with either gender when injectable hormones are placed into the body.”

Adding mental health side effects to drug labels

Once medications are FDA approved and available to the public, doctors are required to continue reporting adverse effects they witness in patients to the FDA Adverse Event Reporting System (FAERS).

“You might pick up some of these adverse effects when something is being used in a million patients. While 1 or 2 in a million people getting a side effect would show up, it would not show up in the original studies for FDA approval, which were conducted on a much smaller number of patients,” said Reddy.

“It doesn’t mean the industry is hiding side effects from the public; it’s really the nature of how the data is collected.”

As adverse effects are documented once medications are used more widely, research is often prompted and the effects are sometimes added to the label.

Takeaway

The fact that Ozempic’s label does not mention anxiety, depression, or suicide on its label yet Wegovy’s label does may be because Wegovy has higher levels of semaglutide.

This disparity may prompt more research on the topic.

If you think you are experiencing mental health effects while taking Ozempic, Wegovy or another GLP-1, contact your doctor immediately.


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