Ozempic has been approved by the Food and Drug Administration to treat type 2 diabetes and has been a huge hit as many people take it to lose weight. As more people try them, more reports of potential side effects are coming to the FDA.
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Ozempic has been approved by the Food and Drug Administration to treat type 2 diabetes and has been a huge hit as many people take it to lose weight. As more people try them, more reports of potential side effects are coming to the FDA.
Mario Tama/Getty Images
Almost three months after taking Ozempic for her diabetes, Jenny Kent has already lost 12 pounds and her blood sugar numbers are better than they were at one point.
Ozempic, an injectable drug approved for type 2 diabetes, has taken the world by storm.
Even though Ozempic is not approved by the Food and Drug Administration for weight loss purposes, people on TikTok and Instagram are encouraging people to guess which stars have used Ozempic to lose weight overnight.
The drug is so popular that it has been in short supply for most of the past year.
But something changed for Kent after he started taking Ozempic.
“I was in a constant state of being overwhelmed,” Kent says. “So my reaction to that was I just kept crying. Sobbing, crying…I still couldn’t get my head around it, so I kept getting shots.”
She is one of many people who take Ozempic and related drugs and complain of mental health problems. However, her side effects are not mentioned in Ozempic’s instructions for use or on the drug’s label. Is the problem a coincidence or drug related?
European regulators investigate mental health reports
In July, the European Medicines Agency said: I was investigating Risk of self-harm and suicidal thoughts from use of Ozempic and similar drugs. As of July 11, regulator Europe’s FDA had evaluated more than 150 reports.
The FDA has not taken that step. For now, authorities are monitoring the situation. “We continue to conclude that the benefits of these drugs outweigh the risks when used according to FDA-approved labeling,” spokesperson Chanapa Tantivanchachai said in an email to NPR. She pointed out that the label for the weight loss drug Wigovy, which contains semaglutide, the same active ingredient as Ozempic, includes a warning about suicidal thoughts.
NPR analyzed the FDA’s Adverse Event Reporting System (FAERS) and found that the agency has received 489 reports of patients experiencing anxiety, depression, or suicidal thoughts while taking semaglutide drugs, including Ozempic, Wigovy, and Libersus. It has been found.
In 96 of these reports, the patient had suicidal thoughts. Five of them died. It is unclear whether Ozempic and other drugs caused mental health problems. The FDA database can flag questions, but it is not designed to answer questions.
“This is an opportunity for people like you and me – patients, carers and healthcare professionals – to report safety events if they feel that their patient has suffered an adverse outcome from a drug they were taking. It’s a passive surveillance system that can do that,” he says. Rishi Desai, Assistant Professor, Harvard Medical School A person who studies the side effects of drugs.
The FDA database is voluntary, not verified by the FDA, and may contain duplicates. As a result, there is no denominator or comparison group to determine whether adverse events such as suicidal ideation are due to the drug or something else.
“It may also be the case that underlying symptoms, such as obesity, for example, are known to increase the risk of mental health problems,” he says. “So you have to consider that carefully. And this database doesn’t really allow you to do that.”
Despite its weaknesses, the FAERS database remains an important tool for FDA, said the agency’s Thanthivanchachai. The FDA will use the information found in his FAERS to conduct further research and possibly change instructions to doctors and patients.
“FAERS data is particularly useful for identifying new (unexpected or unlabeled) rare and serious adverse events that are temporally associated with products that have low background event rates.” she wrote in an email to NPR.
He explained that these types of incidents often do not occur during clinical trials because they 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 may take it for years.
Clinical research to date has yielded few answers.
There is another limitation to pre-approval studies. It’s about who can participate. Dr. Amy Rothberg, endocrinologist at the University of Michigan, states that patients recruited to the Ozempic clinical trial were screened for depression, anxiety, and suicidal ideation. They would have been excluded from participation.
“You know, that’s not necessarily what happens in a clinical setting,” she says. “Therefore, there may be people who have major depressive disorder and who may be receiving treatment, but for whom these drugs may increase the likelihood of their anxiety or depression worsening; That’s something we didn’t take into consideration.”
Rothberg, who then reviewed the FAERS report discovered by NPR, found that nearly all of the patients on the list had underlying serious health conditions and, based solely on the database, that drugs were the cause of suicidal thoughts. He said it is difficult to determine whether this has happened.
Although the link between these drugs and mental health concerns is inconclusive, she says it’s important for patients to talk to their doctor if they notice anything unusual. Dr. Jonathan Alpertchair of 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 side effects seriously, especially with drugs that are relatively new and still being studied,” he says.
Novo Nordisk spokeswoman Alison Scheider said the company takes all reports of new side effects “very seriously,” but added that the drug has been used for more than 15 years.
“Novo Nordisk continues to monitor data from ongoing clinical trials and real-world product use and is committed to ensuring patient safety and appropriate information for healthcare professionals. “We work closely with them,” she says. “Novo Nordisk remains confident in the benefit-risk profile of our products and remains committed to ensuring patient safety.”
What happened to Jenny Kent?
A month and a half after taking Ozempic, Jenny Kent said her mental health issues began to affect her entire life. At work, I found myself responding to mundane demands as if I had been unfairly fired. She withdrew from her friends and began hiding her feelings even from her family.
“I started to feel like I was just a negative burden to everyone,” she says.
Then, belatedly, after a Father’s Day gathering in July, I received a text from my sister Jackie asking, “Are you okay?”
At first, Jenny said it was okay. But after some provocation she succumbed.
“I started talking to her about it, and she said, ‘The only thing that’s changed for you is Ozempico,'” Jenny recalls. “She was like, ‘Are you sure?'” And I said, “No way.” ”
Jackie presses Jenny to consider stopping Ozempic, and Jenny resists because the drug is working for her in every other way.
Jenny Kent (right) said her sister Jackie reached out for help when she experienced mental health issues after taking Ozempic.
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Jenny Kent (right) said her sister Jackie reached out for help when she experienced mental health issues after taking Ozempic.
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When Jenny and Jackie began searching online for information about Ozempic and mental health, they learned about an investigation by European regulators. They also found other U.S. patients who shared experiences like Jenny’s on social media.
Jenny saw her doctor again and it was determined that she should stop taking Ozempic. Although it has only been a few months, his mental condition is gradually improving.
She doesn’t know if stopping Ozempich was the reason, but she says she feels better.
“I’m really in touch with myself,” she says. “I still get irritated easily. Little things can trigger things that didn’t happen before. So it’s still happening. I don’t cry every day. .”
Jackie told NPR that the difference her sister made when she stopped taking Ozempic was “night and day.”
“She’s smiling,” Jackie says. “She realized that for a while she hadn’t heard her heartfelt laughter.”
If you or someone you know may be considering suicide or are in crisis, please call or text us 9 8 8 Reaching Lifeline for Suicide and Crisis.
