Mario Tama/Getty Images
Almost three months after taking Ozempic for diabetes, Jenny Kent had already lost 12 pounds and her blood sugar levels seemed better than they had in a long time.
Ozempic, the approved injectable medication for type 2 diabetes, has taken the world by storm.
Despite not being approved by the Food and Drug Administration for weight loss, Ozempic has led people on TikTok and Instagram to speculate which stars have used it to lose weight seemingly overnight.
The drug has become so popular that it has been in short supply for much of the past year.
But for Kent something changed after he started taking Ozempic.
“I felt constantly overwhelmed,” Kent says. “So my response to that was just that I was crying all the time. Sobbing, crying… I still didn’t get it together, so I kept… giving myself the injections.”
She is one of many people taking Ozempic and related medications who describe mental health problems. But that side effect is not mentioned in Ozempic’s instructions for use or on the drug’s label. Are the problems a coincidence or drug related?
European regulators investigate mental health reports
In July, the European Medicines Agency stated that was investigating the risk of thoughts of self-harm and suicidal thoughts with the use of Ozempic and similar drugs. As of July 11, the regulator, the European FDA, was evaluating more than 150 reports.
The FDA has not taken that step. For now, the agency is monitoring the situation. “We continue to conclude that the benefits of these medications outweigh their risks when used according to FDA-approved labeling,” spokesperson Chanapa Tantibanchachai said in an email to NPR. He noted that the weight-loss drug Wegovy, which contains the same active ingredient as Ozempic, semaglutide, includes a warning about suicidal thoughts on its label.
NPR analyzed the FDA’s adverse event reporting system, or FAERS, and found that the agency has received 489 reports of patients who experienced anxiety, depression or suicidal thoughts while taking semaglutide medications, including Ozempic, Wegovy and Rybelsus.
In 96 of those reports, the patient had suicidal thoughts. Five of them died. It is not known if Ozempic and the other drugs caused the mental health problems. The FDA database may point out questions, but it is not designed to answer them.
“It’s a passive surveillance system where people like you and me (patients, caregivers, medical providers) can report a safety event if they feel that patient has suffered an adverse outcome from a medication they had been taking,” he says. Rishi Desai, assistant professor at Harvard Medical School that studies the side effects of medications.
The FDA database is voluntary, is not verified by the agency, and may contain duplicates. As a result, you have no denominator or comparison group to determine whether adverse events (such as suicidal thoughts) are the result of a medication or something else.
“It could also be the case that the underlying indication, for example obesity, also has a higher risk of mental health problems,” he says. “So we have to take this into account carefully. And this database can’t really do that.”
Despite its weaknesses, the FAERS database remains a critical tool for the FDA, says the agency’s Tantibanchachai. The FDA uses what it finds in FAERS to conduct further research and, in some cases, make changes to instructions for doctors and patients.
“FAERS data are particularly useful for identifying novel (i.e., unexpected or unlabeled), rare, and serious adverse events that are temporally associated with a product for which the event rate is low,” he wrote in an email to NPR. .
He explained that these types of incidents often do not occur during clinical trials of the drug because those studies include relatively small numbers of patients taking the drug for a limited time. Once a drug is on the market, millions of patients can take it for years.
Previous clinical studies offer few answers
There is another limitation to pre-approval studies: who can be part of them. Dr. Amy Rothberg, endocrinologist at the University of Michigan, says patients recruited for Ozempic clinical trials were screened for depression, anxiety, and suicidal thoughts. They would have been excluded from participating.
“You know, that’s not necessarily what happens in clinical practice,” he says. “And so there will be people who have major depressive disorder, who may be receiving treatment, but who may have a higher susceptibility to worsening anxiety or depression with these medications that we just don’t take into account.”
After reviewing the FAERS reports NPR found, Rothberg said almost all of the patients listed had a major underlying health condition that, based on the database alone, would make it difficult to determine whether the medication caused the suicidal thoughts.
Although the link between these medications and mental health problems is not definitive, it is important for patients to talk to doctors if they experience anything unusual, he says Dr. Jonathan Alpertwho chairs the Department of Psychiatry and Behavioral Sciences at Montefiore Medical Center and the Albert Einstein College of Medicine.
“I always think it makes sense to take side effects like that seriously, particularly in drugs that are relatively new and that we’re still learning about,” he says.
Novo Nordisk spokeswoman Allison Scheider says the company takes all reports of new side effects “very seriously,” but added that this class of drugs has been used for more than 15 years.
“Novo Nordisk continually monitors data from ongoing clinical trials and real-world use of its products and works closely with authorities to ensure patient safety and adequate information to healthcare professionals,” it says. “Novo Nordisk remains confident in the risk-benefit profile of the products and remains committed to ensuring patient safety.”
What happened to Jenny Kent?
After a month and a half of taking Ozempic, Jenny Kent said her mental health problems had begun to affect her entire life. At her job, she found herself reacting to ordinary requests as if she were being unfairly fired. She began to distance herself from her friends and hide her feelings from her family.
“I was starting to feel like I was a negative burden on everyone,” he says.
Then he got a text from his younger sister, Jackie, after a late Father’s Day get-together in July: “Are you okay?”
At first, Jenny said it was fine. But after a little prodding, she relented.
“I started talking to her about it and she was the one who said, ‘The only thing that’s changed for you is Ozempic,'” Jenny recalls. “She said, ‘Are you sure that’s not it?’ And I said, ‘There’s no way that can be that.'”
They went back and forth like this for a while, with Jackie pressuring Jenny to consider stopping Ozempic and Jenny resisting, because in every other way the drug was working for her.
Once Jenny and Jackie started searching for information online about Ozempic and mental health, they learned about the investigation by European regulators. They also found other American patients who shared experiences like Jenny’s on social media.
Jenny saw her doctor again and they decided she should stop taking Ozempic. It’s only been a few months, but she says her mental health is slowly improving.
She says she can’t be sure if the reason is to stop Ozempic, but she feels better.
“I’m checking in with myself a lot,” she says. “I still get irritated pretty quickly. Little things just trigger me in a way they didn’t before. So that still happens. I don’t cry every day.”
Jackie told NPR that the difference in her sister after she stopped taking Ozempic was “night and day.”
“She’s laughing,” Jackie says. “I realized she hadn’t heard her laugh genuinely in a long time.”
If you or someone you know may be considering suicide or are in crisis, please call or text 9 8 8 to reach Suicide & Crisis Lifeline.