European and UK Regulators Investigate Suicide Risk With Ozempic and Similar Drugs

Regulators in Europe and the UK are investigating cases of suicidal thoughts reported in some people who were taking Ozempic and several similar drugs for type 2 diabetes and weight loss. The European Medicines Agency (EMA) is reviewing “the risk of suicidal thoughts and thoughts of self-harm” with several drugs in a family of medicines used for weight loss and type 2 diabetes known as GLP-1 receptor agonists, including Ozempic (semaglutide), Saxenda (liraglutide), and Wegovy (semaglutide). Regulators are investigating about 150 possible cases of self-injury and suicidal thoughts connected to these medicines, EMA said in a statement issued July 11…..CONTINUE READING

In the UK, the medicines and healthcare products regulatory agency MHRA has launched a similar investigation, according to a July 26 report by Reuters. British regulators are looking at drugs involved in the EMA investigation, as well as the GLP-1 drugs Bydureon (exenatide), Lyxumia (lixisenatide), and Trulicity (dulaglutide), Reuters reported.

“I think it is appropriate that there is additional oversight to the use of these medications, especially as they expand into broader public use and misuse,” says Beverly Tchang, MD, an assistant professor of clinical medicine at Cornell University in Ithaca, New York, who treats patients with obesity and type 2 diabetes at at Weill Cornell Medicine in New York City.

Ozempic and Wegovy Remain in Short Supply in the U.S.

Two GLP-1 drugs containing the active ingredient semaglutide, the type 2 diabetes drug Ozempic and the weight loss medicine Wegovy, have been in short supply domestically for many months now. The shortages are being driven in large part by the growing number of people without obesity or diabetes who want these medicines to help them lose weight, Dr. Tchang says.

Two GLP-1 drugs approved by the U.S. Food and Drug Administration (FDA) for weight loss — Wegovy and Saxenda — already carry warnings about suicidal behavior and thoughts.

“The labeling recommends that patients treated with these medications be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and any unusual changes in mood or behavior; to discontinue these medications in patients who experience suicidal thoughts or behaviors; and to avoid these medications in patients with a history of suicidal attempts or active suicidal ideation,” the FDA said in a statement to Everyday Health.

FDA Says There’s No Risk of Suicidal Thoughts With Ozempic

Ozempic, which is FDA-approved only for type 2 diabetes, carries no such warning. The FDA said that “clinical trial data did not support a warning and precaution for suicidal ideation or behavior for the GLP-1 receptor agonists approved for diabetes indications.”

Overall, however, the FDA said GLP-1 drugs are safe. “We continue to conclude that the benefits of these medications outweigh their risks when they are used according to the FDA-approved labeling,” the FDA said.

Unlike in the United States, GLP-1 drugs in Europe and the UK don’t already carry warnings about suicidal thoughts or behaviors. Because there already are warnings on some GLP-1 drugs in the United States, an FDA investigation into this side effect is unlikely, says Joshua Zeichner, MD, an associate professor of dermatology at Mount Sinai Hospital in New York City who helps patients manage skin side effects from Ozempic.

It’s also possible that European regulators are investigating the suicide risk of GLP-1 drugs because of a totally different type of weight loss medicine, Acomplia (rimonabant), was pulled from the market in 2008 over serious psychiatric side effects, Tchang says. This drug was never approved in the United States.

Is It Worth It to Take Ozempic or Wegovy?

For now, the best course of action for patients is to take medicines prescribed by their doctors as directed, Dr. Zeichner says. “All medications come with potential side effects,” Zeichner adds. “However, if their overall benefit outweighs the risk of developing one of those side effects or the impact of one of those side effects, then the medication is worth taking.”

When it comes specifically to psychiatric side effects, patients should take the warnings about the risk of suicidal thoughts and behavior seriously, Tchang says. “Patients should discuss any mood changes they have with their doctor,” Tchang advises. “Regardless of whether they are taking a GLP-1 or not, they should always seek help if they have thoughts about harming themselves…..CONTINUE READING