HEALTH

European regulators probe risks of suicidal thoughts in users of popular weight-loss medications

Jul 11, 2023, 8:13 AM | Updated: 9:07 am

Boxes of the diabetes drug Ozempic are seen here on April 17 in Los Angeles. The European Medicines...

Boxes of the diabetes drug Ozempic are seen here on April 17 in Los Angeles. The European Medicines Agency’s safety committee is looking into the risk of suicidal thoughts and thoughts of self-harm in patients who used popular medicines for weight loss, like Ozempic. (Mario Tama/Getty Images via CNN)

(Mario Tama/Getty Images via CNN)

 🔊Sound up for our report 👇 from ABC NewsRadio


 

Originally Published: 10 JUL 23 13:27 ET
Updated: 10 JUL 23 14:48 ET

(CNN) — The European Medicines Agency’s safety committee is looking into the risk of suicidal thoughts and thoughts of self-harm in patients who used popular medicines for weight loss, like Ozempic, the regulator told CNN Monday.

The review comes after three case reports raised by the Icelandic Medicines Agency, the regulator said by email. Two were cases of suicidal thoughts, one following the use of Ozempic and another after use of another drug, called Saxenda. The third case involved thoughts of self-injury with Saxenda, the EMA said.

Ozempic, which contains the drug semaglutide, is cleared for type 2 diabetes, while Saxenda contains a similar drug called liraglutide and is approved for chronic weight management. Both are made by Novo Nordisk.

The EMA notes that suicidal behavior isn’t currently listed as a side effect in the European Union product information for the medicines and said its safety committee will consider whether the review should extend to other medicines in the class, known as GLP-1 receptor agonists. The group includes Wegovy, the version of semaglutide approved for chronic weight management, and Mounjaro, a drug from Eli Lilly currently approved for diabetes.

Novo Nordisk told CNN on Monday that “patient safety is a top priority” and said it takes “all reports about adverse events from use of our medicines very seriously.”

The US prescribing information for Saxenda includes a recommendation to monitor patients for depression or suicidal thoughts and to discontinue the drug if symptoms develop. Clinical trials in adults found that nine people on the drug, of more than 3,300, reported suicidal ideation, compared with two of more than 1,900 on a placebo. One adult on Saxenda attempted suicide, the prescribing information says. In pediatric clinical trials, one person on Saxenda died by suicide, of 125 studied. The prescribing information says “there was insufficient information to establish a causal relationship to Saxenda.”

There is no similar warning in the US prescribing information for Ozempic, although the information for Wegovy notes that suicidal behavior and ideation have been reported in clinical trials with other weight management products and says patients should be monitored for depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior.

The US Food and Drug Administration told CNN on Monday that it “routinely evaluates individual adverse event reports and adverse event reports from the published literature for all approved drugs” and doesn’t comment on third-party research or individual reports “as a general matter.” The agency said it continues to monitor the safety of medicines post-approval and has a system of surveillance and risk-assessment programs, and if new safety signals are identified, it will determine which steps to take.

In 2008, the weight loss drug Acomplia, made by French drugmaker Sanofi, was pulled from the European market over concerns about suicidal thoughts. The drug, which works in a different way than GLP-1 medicines, was never cleared in the US.

These newer weight loss medications have been surging in popularity. They work by mimicking the effects of an appetite-regulating hormone called GLP-1. They stimulate the release of insulin, which helps lower blood sugar, and slow the passage of food through the gut. The FDA approved semaglutide for diabetes as Ozempic in 2017 and for weight loss as Wegovy in 2021.

The drugs have known gastrointestinal side effects like nausea, vomiting and diarrhea.

The-CNN-Wire
™ & © 2023 Cable News Network, Inc., a Warner Bros. Discovery Company. All rights reserved.

We want to hear from you.

Have a story idea or tip? Send it to the KSL NewsRadio team here.

Health

FILE -- A comfort dog waits for its owner at Salt Lake City International Airport. Experts warn to ...

Britt Johnson

Traveling puts pets at greater risk for canine influenza

Experts warn that now is the time to get pet dogs immunized against canine influenza. 

5 days ago

People present their pets during an animal fashion show....

Mariah Maynes

Here are the health benefits of having pets

According to the USU Extension, interacting with and caring for pets can have positive impacts on your health.

5 days ago

(Canva)...

Michelle Lee

Boost your immune system with good nutrition

Let’s Get Moving Host Maria Shilaos spoke with Functional Medicine Nutritionist Karin Reiter to learn how nutrition affects our immune system.

7 days ago

An apple pie surrounded by apples....

Kennedy Camarena

Study shows how processed foods aren’t so great for you

It's always been a pretty well-known fact that processed foods are not that great for people. Now, there's a new study to prove it.

8 days ago

FILE: A two-year-old, plays with dogs outside their home in Ogden on Sunday, Aug. 6, 2023. (Megan N...

Britt Johnson

The spring season leads to increased cases of canine parvovirus

Parvo is especially dangerous for young dogs. It has the potential to wreak havoc on their digestive system.

9 days ago

Image of a teenager using a cell phone between classes at Cyprus High School in Magna on Friday, Ja...

Curt Gresseth and Kyle Remund

Norway’s ban on cellphones in middle schools shows positive results. Will Utah do the same?

A brain performance specialist discusses a study that found improvements in girls' grades and a dropoff in school bullying for both boys and girls after Norway banned cellphones in middle schools.

11 days ago

Sponsored Articles

a doctor putting her hand on the chest of her patient...

Intermountain Health

Intermountain nurse-midwives launch new gynecology access clinic

An access clinic launched by Intermountain nurse-midwives provides women with comprehensive gynecology care.

Young couple hugging while a realtor in a suit hands them keys in a new home...

Utah Association of Realtors

Buying a home this spring? Avoid these 5 costly pitfalls

By avoiding these pitfalls when buying a home this spring, you can ensure your investment will be long-lasting and secure.

a person dressed up as a nordic viking in a dragon boat resembling the bear lake monster...

Bear Lake Convention and Visitors Bureau

The Legend of the Bear Lake Monster

The Bear Lake monster has captivated people in the region for centuries, with tales that range from the believable to the bizarre.

...

Live Nation Concerts

All the artists coming to Utah First Credit Union Amphitheatre (formerly USANA Amp) this summer

Summer concerts are more than just entertainment; they’re a celebration of life, love, and connection.

Mother and cute toddler child in a little fancy wooden cottage, reading a book, drinking tea and en...

Visit Bear Lake

How to find the best winter lodging in Bear Lake, Utah

Winter lodging in Bear Lake can be more limited than in the summer, but with some careful planning you can easily book your next winter trip.

Happy family in winter clothing at the ski resort, winter time, watching at mountains in front of t...

Visit Bear Lake

Ski more for less: Affordable ski resorts near Bear Lake, Utah

Plan your perfect ski getaway in Bear Lake this winter, with pristine slopes, affordable tickets, and breathtaking scenery.

European regulators probe risks of suicidal thoughts in users of popular weight-loss medications