- EU regulators are investigating about 150 reports of suicidal thoughts and self-harm in patients taking GLP-1 drugs.
- It's unclear whether the issues are actually tied to the drugs Wegovy, Ozempic, and Saxenda.
The number of reports of suicidal thoughts and self-harm in patients taking the new weight-loss drug Wegovy and other similar medications has quickly skyrocketed — from just three, to about 150.
The European Medicines Agency said in a statement on Tuesday that a review triggered by Icelandic reports of three cases earlier this week has brought up "about 150 reports of possible cases of self-injury and suicidal thoughts" in patients across the European Union taking three different injectable GLP-1 medications, all from drugmaker Novo Nordisk.
The EU investigation centers on semaglutide, the hormone-mimicking drug branded as Ozempic for Type 2 diabetes and Wegovy for weight loss, as well as one similar, older diabetes drug from Novo Nordisk, called liraglutide or Saxenda.
Regulators aren't sure yet whether these reports are actually linked to the medications themselves, "or to the patients' underlying conditions or other factors," the EMA said in the statement.
Already, tens of millions of prescriptions have been written for these drugs across Europe, with regulators saying more than 20 million "patient-years" have been logged across the EU. That's the equivalent of 20 million people taking these drugs for one year.
It's still unclear whether or not this potential issue is being scrutinized in the US. Regulators at the Food and Drug Administration (FDA) haven't reported similar cases yet — though they are monitoring patient complaints.
"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," a US Food and Drug Administration official told Insider in an emailed statement. "If newly identified safety signals are identified, the FDA will determine what actions are appropriate after a thorough review of the body of evidence."
Dr. Amy Rothberg, director of The University of Michigan's weight management clinic, told Insider in an email Wednesday that there has been an "explosion" of people taking drugs like Wegovy recently.
In her practice, she's dealt with one young man who experienced heightened anxiety on the drug, and one middle-aged woman who had suicidal thoughts while taking it.
"I do counsel patients now about the rare risk" for more anxiety, depression, or suicidal thoughts with Wegovy, she said.
GLP-1 drugs influence hormones in our brains
Ozempic, Wegovy, and Saxenda all work by changing the chemistry of the brain, artificially bumping up levels of a hunger-regulating hormone that humans produce naturally.
The way these hunger hormones function in the brain isn't fully understood by scientists. But the potency of the older diabetes drugs, Saxenda and Ozempic, is lower than Wegovy, which is prescribed for weight loss and has a higher dose of semaglutide in each injection.
The FDA said in their emailed statement that while clinical trials of Wegovy "did not support an increased risk of suicidal behavior, suicidal ideation, or other psychiatric adverse events," the agency still recommends that doctors in the US monitor patients who are on Wegovy and who have a history of depression or suicidal behaviors or thoughts.
Suicidal behavior and ideation is listed among the other FDA warnings and precautions for Wegovy, alongside issues including acute pancreatitis and heart rate increase.
Suicidal thoughts, anxiety, and depression have been linked to other weight loss drugs in the past, like phentermine. A weight loss drug called rimonabant, approved in the EU in 2006 as Acomplia but never sold in the US, was taken off the market worldwide in 2008 due to concerns about serious psychiatric effects of the drug, including depression and suicidal thoughts.
Have you dealt with unexpected side effects while taking a GLP-1 weight-loss medication? Reach out to reporter Hilary Brueck at hbrueck@insider.com