In the months before his death, Anthony seemed in good spirits: He had recently proposed to his girlfriend and been promoted at work. At Christmas, his oldest daughter had surprised him with the news that she was pregnant with his second grandchild.
But Anthony’s sister, Merlene Hall — who asked that he be identified only by his first name to respect his children’s privacy — said her brother became uncharacteristically quiet around the time he started taking Ozempic in February to manage his Type 2 diabetes. By early May, Anthony’s family said, he seemed fatigued, and his newly sullen mood appeared to be getting worse.
“He’s usually very charismatic, talking and joking. He’s a pretty outgoing guy. But he was fairly quiet,” his fiancé, Carolyn Hasty, said.
On the morning of May 14, Anthony died by suicide at his home in Indiana.
Although he had experienced depression in the past, his family was shocked by his death and attributes it to Ozempic.
“I think the Ozempic was putting these suicidal thoughts in his mind,” Hall said.
In this and most other cases of suicide, it is impossible to pinpoint a single cause, as a complex set of factors often interplay. However, as Ozempic and its sister medication, Wegovy, have skyrocketed in popularity, a small number of patients — some with a history of depression — have begun to report experiencing suicidal thoughts that they believe are a side effect of the drug.
The European Medicines Agency said in July that it was reviewing 150 reports of self-injury and suicidal thoughts from people who took GLP-1 receptor agonists, the drug class that includes Ozempic and Wegovy. The U.K.’s Medicines and Healthcare products Regulatory Agency told Reuters that it, too, was reviewing safety data about the drugs following similar reports.
In the United States, the Food and Drug Administration’s adverse event reporting system, or FAERS, had received 59 reports of suicidal ideation, six reports of suicide attempts and four reports of suicide related to Ozempic as of June 30. Wegovy — which carries a warning about suicidal thoughts — had six reports of suicidal ideation and no reports of suicide or suicide attempts.
But those tallies are self-reported events and the FDA had not necessarily verified that they were caused by the medications. The numbers are also small relative to how many people take Ozempic: Data from Novo Nordisk, the maker of Ozempic and Wegovy, indicates that U.S. providers were writing about 60,000 new weekly Ozempic prescriptions as of April.
Three doctors who routinely prescribe Ozempic and Wegovy told NBC News they weren’t noticing a link to suicidal thoughts. The doctors give expert advice to Novo Nordisk in exchange for financial compensation, but they do not speak on behalf of the company. NBC News identified them through their work with university-affiliated medical centers. It is common for doctors who specialize in weight management drugs to advise companies that make such medications.
Clinical trials also did not find an association between Ozempic and suicidal thoughts.
But Anthony’s family believes Ozempic should come with a warning about self-injury or suicidal thoughts as a potential risk. The drug’s prescribing label has no such information listed. Wegovy’s label has a warning because it is approved for weight loss, and the FDA requires a warning about suicidal ideation for chronic weight management medications that work on the central nervous system.
Ozempic and Wegovy are both versions of the drug semaglutide at different dosages. The former is approved only for diabetes; any use of it for weight loss is considered off-label, according to the FDA.
Though Anthony was prescribed Ozempic for diabetes, he saw weight loss as a welcome side effect, his family said. He lost roughly 50 pounds over three months while taking the drug.
Hall reported Anthony’s death to the FDA and to Novo Nordisk in June. The company reached out to his doctor for more information in July, according to correspondence reviewed by NBC News, but Hall does not know if Novo Nordisk has taken further action. Neither she nor Hasty are pursuing legal action.
Novo Nordisk said it cannot comment on individual cases but that it investigates all reports of adverse events. The company added that it remains confident in the benefit-risk profile of Ozempic and works closely with the FDA and other regulatory agencies to ensure that the product’s label appropriately reflects its safety and efficacy.
“The totality of available evidence — which includes clinical studies and data from real world-use — does not suggest an increased risk of suicide or self-injurious behavior with Ozempic,” Novo Nordisk said in a statement. “In completed Ozempic clinical studies, no events of suicide or self-injury were reported in patients treated with Ozempic.”
The FDA, meanwhile, confirmed to Hall that it had received her report, but in response to an NBC News inquiry, the agency said it could not comment on specific cases. The FDA said it monitors the safety of drugs through surveillance and risk assessment programs to identify adverse events that did not appear in early trials.
“If a new safety signal for suicidal ideation/behavior is identified, the FDA will determine what actions are appropriate after a thorough review of the total body of evidence,” said Chanapa Tantibanchachai, a press officer at the FDA.
Could suicidal thoughts be related to side effects of Ozempic, like eating less?
Anthony’s family believes strongly that he would still be alive had he not started Ozempic.
“We all just said immediately, ‘It has to be linked to this. It just has to be,’” Hasty said.
But in his case and others, determining whether the drug was to blame is difficult. Anthony had a thyroid disorder, Hall said, so she wonders if that may also have affected his mood. A few studies have suggested that such conditions might be linked to suicidal behavior, though a research analysis in 2021 concluded that the evidence was insufficient.
Anthony had also experienced anxiety and depression before he started Ozempic, although he had never attempted suicide in the past, Hall said. Still, his family said that the last time he’d lost roughly as much weight as he did on Ozempic — in April 2022 — he had told his fiancé he was having suicidal thoughts.
“I came home and he was sitting in the kitchen and he said, ‘Help me, babe, you got to help me. I just feel like killing myself,’” Hasty said.
Anthony’s family said his longtime physician, who prescribed Ozempic to him, was aware of that history. But Anthony was not told that the drug might worsen his mental health, his family said. His doctor declined to comment.
“He really never should have been started on this,” Hall said. “If the health care providers were informed about this properly, my brother would not have been a candidate for it, or he would have been watched closer.”
The doctors interviewed said they have prescribed Ozempic to patients with a history of depression and have not observed any signs of suicidal thoughts that seem related to the medication. As far as they know, they said the medication doesn’t contain active ingredients that induce suicidal thoughts.
“There is nothing in the drug that would cause someone to think about suicide,” said Dr. Caroline Apovian, co-director of the Center for Weight Management and Wellness at Brigham and Women’s Hospital, who sits on Novo Nordisk’s scientific advisory board.
It is not standard to ask patients whether they’re experiencing suicidal thoughts while taking Ozempic, since it’s not mentioned in the prescribing label.
But Dr. Eduardo Grunvald, an obesity medicine physician at UC San Diego Health who consults for Novo Nordisk, said reports of suicide or suicidal thoughts are worth paying attention to, even if clinical trials have not shown an elevated risk.
“If you have a patient on these medications, it’s worth asking about when you see them if their mood has changed,” Grunvald said of Ozempic and Wegovy.
One possible explanation for why some people report feeling suicidal on Ozempic could be the change in eating habits it causes, according to Dr. Carolina Solis-Herrera, medical director of the Diabetes, Obesity and Endocrinology clinics at UT Health San Antonio.
Solis-Herrera, a scientific adviser for Novo Nordisk and member of the company’s speaker bureau, said some people use food as a way to cope with depression or self-soothe, but Ozempic can decrease appetite so much that some people don’t enjoy meals anymore.
“Food is pleasure,” Solis-Herrera said. “When you take that away because now you’re taking a medication that curbs your appetite, there might be some feelings of sadness.”
Several studies of patients who have undergone bariatric surgery offer evidence for that hypothesis: Suicide rates are at least four times higher among that group than the general population.
But Grunvald said the theory isn’t convincing.
“It’s a big leap to go from not having that pleasure of eating to wanting to kill yourself,” he said. “I don’t think there’s any scientific evidence that that might be the case.”
Ozempic also has effects on brain chemistry.
Semaglutide mimics a hormone, GLP-1, that travels from the gut to the brain and decreases the activity of the brain’s reward center. That may help explain why some people say Ozempic has decreased their urge to drink, smoke, shop or gamble. In some patients, the medication might even decrease the feeling of pleasure altogether, according to Apovian.
That could be a sign that Ozempic isn’t the right drug for those individuals, she said, though drugs like Ozempic and Wegovy can also improve people’s well-being.
“There are many, many people who come back and tell me that they feel great,” Apovian said. “I just had one this morning: For the first time in her life, she doesn’t have an eating disorder. She doesn’t obsess about food constantly all day long. What this drug did for her was far and above better than any cognitive behavioral therapy she’s used.”
Should Ozempic come with a warning?
Anthony’s family wants Ozempic to carry an even stronger warning about a risk of suicide than Wegovy already does: a black box warning from the FDA. This type of label comes on the packaging of medications with serious safety risks — not just the prescribing information for doctors — to notify the public about severe side effects.
“I’m not trying to say that I believe this medicine is a bad medicine overall. I think that it probably offers a lot of benefits to a lot of people,” Hasty said. “But I believe that there is a subpopulation out there, a portion of this population that they’re giving it to, that has to be more highly monitored and decide whether or not it’s a good drug for them.”
Hasty said Anthony didn’t express any desire to kill himself during his last months. The two had known each other in high school, then reconnected on Facebook later in life. They were looking forward to their 40-year reunion this year, she said, and their classmates had planned a surprise to celebrate their engagement.
“His life mattered. It mattered to a lot of people,” she said. “And I know he didn’t want to die.”
If you or someone you know is in crisis, call 988 to reach the Suicide and Crisis Lifeline. You can also call the network, previously known as the National Suicide Prevention Lifeline, at 800-273-8255, text HOME to 741741 or visit SpeakingOfSuicide.com/resources for additional resources.
Source: | This article originally belongs to Nbcnews.com
