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Ozempic being investigated for suicidal thoughts…



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Behind paywall, here is verbiage:

Ozempic is under review by European drug-safety regulators after they received reports of suicidal thoughts linked to the popular weight-loss drug and another medicine in the class.

The European Medicines Agency said Monday it is evaluating the safety risk for patients who take the drugs, manufactured by Novo Nordisk, after learning that three people who took the medicines reported thoughts of self harm or suicide.

Suicidal behavior isn’t listed as a side effect for Ozempic—and a related drug called Saxenda that is also subject to the review—in the European Union, the EMA said.

Novo Nordisk said the company’s studies of Ozempic and Saxenda, as well as its continuing monitoring of their use, haven’t shown a link to suicidal thinking or thoughts of self harm.

“Novo Nordisk remains confident in the benefit risk profile of the products and remains committed to ensuring patient safety,” a Novo Nordisk spokeswoman said.

Depositary shares in Denmark-based Novo Nordisk were flat in trading on the New York Stock Exchange midday Monday.

Ozempic, Saxenda and other drugs targeting a gut and brain hormone called glucagon-like peptide-1, or GLP-1, have exploded in popularity after studies found they can help people lose significant weight.

Companies initially developed the class to treat people with diabetes. Ozempic, which is approved for diabetes treatment, has a sister drug named Wegovy that is cleared for chronic weight management in people who are obese.

The U.S. food and Drug Administration said it doesn’t comment on external research or individual reports, but may evaluate them. It said clinical trials for Wegovy didn’t support an increased risk of suicidal thoughts or behavior.

Prescribing information for Wegovy, however, includes a warning and precaution for these risks because it has been reported in clinical trials for other weight-management drugs, the FDA said.

The EMA said it would consider whether to expand its inquiry to other GLP-1 drugs.

The agency said it began its review after the Icelandic Medicines Agency reported suicidal thoughts by one user of Ozempic and similar thoughts by a user of an older drug in the class called Saxenda.

A third case reported by the Icelandic agency involved thoughts of self-injury by a user of Saxenda.

Write to Melanie Evans at melanie.evans@wsj.com

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Most medications that regulate the appetite can have an effect on the brain and mood; when you take away someone's coping mechanism/dopamine source (a lot of overweight/obese people self-medicate depression and other demons with food), it makes those feelings you were stuffing down come roaring back to the forefront.

If anything this is a cautionary warning that those who use it who struggle with their mental health should probably be under the care of a professional therapist or psychologist during their treatment with this medication.

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