Ozempic, approved by the Food and Drug Administration for type 2 diabetes, is seeing market sales because many people are taking it to lose weight. As more people try it, FDA reports of possible side effects increase.
Mario Tama/Getty Images
hide label
switch subtitle
Mario Tama/Getty Images
Ozempic, approved by the Food and Drug Administration for type 2 diabetes, is seeing market sales because many people are taking it to lose weight. As more people try it, FDA reports of possible side effects increase.
Mario Tama/Getty Images
Almost three months after taking Ozempic for diabetes, Jenny Kent lost 12 pounds and her blood sugar looked better than it had in a while.
Ozempic, an injectable drug approved 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 gotten people on TikTok and Instagram speculating about which stars have used it to shed pounds seemingly overnight.
The drug became so popular that it was in short supply for most of last year.
But something else changed for Kent after she started taking Ozempic.
“I was constantly in a state where I was overwhelmed,” Kent says. “So my response was that I just kept crying the whole time. Sobbing, crying… I still couldn’t get it together, so I kept… injecting myself.”
She is one of many people taking Ozempic and related drugs who describe mental health issues. But this side effect is not listed in the instructions for use of Ozempic or on the label of the drug. Are the problems coincidental or drug related?
European regulators examine mental health reports
In July, the European Medicines Agency said it was investigating the risk of thoughts of self-harm and suicidal thoughts when taking Ozempic and similar medicines. As of July 11, the regulator, the European FDA, had evaluated more than 150 reports.
The FDA has not taken this step. The agency is currently monitoring the situation. “We continue to conclude that the benefits of these drugs outweigh their risks when used as FDA-approved,” spokesman Chanapa Tantibanchachai said in an email to NPR. She noted that Wegova’s weight loss drug, which contains the same active ingredient as Ozempic, semaglutide, has a label warning against suicidal thoughts.
NPR analyzed the FDA’s adverse event reporting system, or FAERS, and found that the agency received 489 reports of patients experiencing anxiety, depression or suicidal thoughts while taking semaglutide drugs, including Ozempic, Wegova and Rybelsus.
In 96 of these reports, the patient had suicidal thoughts. Five of them died. It is not known whether Ozempic and other drugs have caused mental health problems. The FDA database may flag questions but 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 a patient has suffered an adverse outcome from a drug they’ve been taking,” says Rishi Desai. an assistant professor at Harvard Medical School who studies the side effects of drugs.
The FDA database is voluntary, not verified by the agency, and may have duplicates. As a result, it has no denominator or comparison group that can determine whether adverse events—like suicidal thoughts—are the result of the drug or something else.
“It could also be that the underlying indication, for example obesity, is also known to have a higher risk of mental health problems,” he says. “So we have to account for that carefully. And this database isn’t really capable of that.”
Despite its weaknesses, the FAERS database is still a critical tool for the FDA, says the agency’s Tantibanchachai. The FDA uses what it finds in FAERS to further research and, in some cases, make changes in guidance for doctors and patients.
“FAERS data are particularly useful for identifying new (ie, unexpected or unlabeled), rare, serious adverse events that are temporally associated with a product for which the background of events is low,” she wrote in an email to NPR.
She explained that these kinds of incidents don’t often happen during clinical trials of a drug because those trials involve a relatively small number of patients taking the drug for a limited period of time. Once a drug is on the market, millions of patients can use it for years.
Previous clinical studies offer few answers
Pre-approval studies have another limitation: Who can be a part of them. Dr. Amy Rothberg, an endocrinologist at the University of Michigan, says patients enrolled in Ozempic’s clinical trials were screened for depression, anxiety and suicidal thoughts. They would be excluded from participation.
“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 can be treated but may have an increased susceptibility to worsening anxiety or depression on these medications that we just haven’t anticipated.”
After reviewing the FAERS reports found by NPR, Rothberg said nearly every patient listed had an underlying serious medical condition that would make it difficult to determine whether the drug caused suicidal thoughts based on the database alone.
While the link between these drugs and mental health concerns isn’t definitive, it’s important for patients to talk to their doctors if they experience anything unusual, says Dr. Jonathan Alpert, who chairs the Department of Psychiatry and Behavioral Sciences at Montefiore Medical Center and Albert. Einstein College of Medicine.
“I always think it makes sense to take these kinds of side effects seriously, especially with drugs that are relatively new and that we’re still learning about,” says Alpert, who also chairs the American Psychiatric Association’s Research Council.
Novo Nordisk spokeswoman Allison Scheider says the company takes all reports of new side effects “very seriously,” but added that the class of drugs has been used for more than 15 years.
“Novo Nordisk constantly 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 for healthcare professionals,” he says. “Novo Nordisk remains confident in the product’s benefit-risk profile and is committed to patient safety.”
What happened to Jenny Kent?
After a month and a half of taking Ozempic, Jenny Kent said her mental health issues began to affect her whole life. At work, she found herself responding to routine requests as if she had been unfairly fired. She began to withdraw from her friends and hide her feelings from her family.
“I was starting to feel like I was just a negative burden to everyone,” she says.
After a belated Father’s Day reunion in July, she got a text from her younger sister Jackie: “Are you okay?”
At first Jenny said she was fine. But after some prodding she relented.
“I started talking to her about it, and she’s the one who said, ‘The only thing that’s changed for you is Ozempic,'” Jenny recalls. “She says, ‘Are you sure it’s not?'” And I said : ‘There is no way it could be so.’ “
They went back and forth for a while, with Jackie urging Jenny to consider stopping the Ozempica and Jenny resisting because in every other way the drug was taking its toll on her.
Jenny Kent (right) says her younger sister Jackie helped her get help when she had mental health problems after taking Ozempic.
Jenny Kent
hide label
switch subtitle
Jenny Kent
Jenny Kent (right) says her younger sister Jackie helped her get help when she had mental health problems after taking Ozempic.
Jenny Kent
As Jenny and Jackie began searching online for information about Ozempic and mental health, they learned of an investigation by European regulators. They also found other American patients who shared experiences like Jenny’s on social media.
Jenny went back to her doctor and they decided she should stop taking Ozempic. It’s only been a few months, but she says her mental health is improving bit by bit.
She says she can’t be sure if she’s the reason Ozempica stopped, but she feels better.
“I watch myself a lot,” she says. “I still get very irritable pretty quickly. Like little things trigger me in a way that wouldn’t have happened before. So it 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.”
“He’s laughing,” says Jackie. “I realized I hadn’t heard her genuinely laugh in a long time.
If you or someone you know is having suicidal thoughts or is in crisis, call or text 9 8 8 you will reach the Suicide & Crisis Lifeline.
#Ozempic #increases #reports #potential #mental #health #side #effects
