Regulators examine reports of self-harm, suicidal thoughts among people taking Ozempic, Saxenda
Regulators in Europe have launched a review after three people in Iceland experienced thoughts of suicide or self-harm after taking popular diabetes and weight loss drugs Ozempic and Saxenda.
The review is being led by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee out of an abundance of caution.
The agency said Tuesday that its review will conclude by November 2023, and has expanded to review 150 cases.
At this point, it's not clear if people experienced thoughts of suicide or self-harm due to an underlying mental health condition, or whether these thoughts were related to starting drugs like Ozempic and Saxenda, which are called GLP-1 receptor agonists.
"The presence of a signal does not necessarily mean that a medicine caused the adverse event in question," the agency said in a statement.
Still, experts say it important for regulators to diligently review any new possible health concern related to approved drugs.
Suicide is not currently listed as a side effect of Ozempic, according to the U.S. Food and Drug Administration's drug label. That means it is not a safety problem that emerged during the large clinical trials that were done to test for safety and effectiveness.
Ozempic, Saxenda and others are part of a class of drugs called GLP-1 RAs that help people produce insulin and lower the amount of sugar in the blood.
The drugs, made from a compound called semaglutide, work by slowing down movement of food through the stomach and curbing appetite, thereby causing weight loss.
Ozempic was approved by the FDA in 2017 to treat Type 2 diabetes, but some doctors prescribe it "off-label" for weight loss.
Saxenda and another drug, Wegovy, are both FDA approved for weight loss for people with obesity or who are overweight.
These drugs have not previously been associated with thoughts of self-harm.
However, prior weight loss medications have been associated with thoughts of self-harm. For that reason, Wegovy and Saxenda are not recommended for people with have previously had suicidal thoughts.
Known side effects of the drugs can include severe nausea and constipation.
Saxenda, Wegovy and Ozempic are all made by Novo Nordisk.
The pharmaceutical company told ABC News in a statement that it is "continuously performing surveillance" of the data and real-world uses of the drugs to ensure patient safety.
"Patient safety is a top priority for Novo Nordisk, and we take all reports about adverse events from use of our medicines very seriously. GLP-1 receptor agonists have been used to treat type 2 diabetes for more than 15 years and for treatment of obesity for 8 years, including Novo Nordisk products such as semaglutide and liraglutide that have been on the market for more than 10 years," Novo Nordisk said in a statement. "In the US, FDA requires medications for chronic weight management that work on the central nervous system, including Wegovy® and Saxenda®, to carry a warning about suicidal behavior and ideation. This event had been reported in clinical trials with other weight management products."
"Novo Nordisk is continuously performing surveillance of the data from ongoing clinical trials and real-world use of its products and collaborates closely with the authorities to ensure patient safety and adequate information to healthcare professionals," the statement continued. "Novo Nordisk remains confident in the benefit risk profile of the products and remains committed to ensuring patient safety.”
The FDA also told ABC News it "routinely evaluates" approved drugs for safety.
The agency has so far not followed its European counterparts in announcing a review of GLP-1 RAs.
"The FDA routinely evaluates individual adverse event reports and adverse event reports from the published literature for all approved drugs," the FDA said in a statement. "As a general matter, the FDA does not comment on third-party research or individual reports but may evaluate these as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health."
"Clinical trials of Wegovy did not support an increased risk of suicidal behavior, suicidal ideation, or other psychiatric adverse events with Wegovy; however, suicidal behavior and ideation have been reported in clinical trials of other weight management drugs. For this reason, the US prescribing information for Wegovy contains a Warning and Precaution for suicidal behavior and ideation," the statement continued. "The FDA monitors the safety of a drug throughout its life cycle, including post-approval. In addition, the FDA maintains a system of postmarketing surveillance and risk assessment programs and if newly identified safety signals are identified, the FDA will determine what actions are appropriate after a thorough review of the body of evidence."
Doctors say anyone experiencing thoughts of self-harm for any reason should quickly reach out to a professional.
If you or someone you know is struggling with thoughts of suicide — free, confidential help is available 24 hours a day, 7 days a week. Call or text the national lifeline at 988. Even if you feel like it, you are not alone.
Editor's note: This story has been updated to reflect a newly-released statement from the European Medicines Agency.
