Links between Ozempic and suicidal thoughts are becoming “more credible”, a former US health chief has claimed.
The Food and Drug Administration (FDA) has received hundreds of reports of suicidal thoughts and depression from patients taking weight-loss medications since 2010, as well as 36 deaths “due to suicide or suspected suicide.”
Of the adverse events, a significant number occurred shortly after starting the medications or increasing those doses, only to disappear when patients stopped taking them.
Patients include a mother of four who said she felt like she didn’t want to be here anymore and a nurse who wanted to shoot herself.
Dr. Erick Turner, who used to work for the FDA but now works at Oregon Health and Science University, said the fact that many patients stopped experiencing suicidal thoughts when they stopped the drug made it “more difficult to explain the suicide”.
Dawn Heidlebaugh, a mother of four from Ohio, said taking Ozempic made her feel suicidal (pictured).
The FDA Adverse Event Reporting System (FAERS) has received a total of 265 reports of suicidal thoughts and depression, reports Reuters.
They include reports from patients taking Wegovy and Ozempic, made by Novo Nordisk, and Mounjaro, made by Eli Lilly.
Reports of suicidal thoughts related to these medications are unverified and may be reported by patients and doctors.
The system is supposed to act as a crude early warning system for side effects that may have gone undetected during clinical trials and to allow officials to detect rare side effects of the drugs.
However, the data must be carefully analyzed to determine whether any patterns are caused by the medication or due to another factor.
Ozempic may be linked to suicide in patients because it prevents them from eating regularly, which may be a coping mechanism for other emotions.
People who are severely overweight are also more likely to suffer from depression and are more likely to take the medication in the first place.
But Dr. Turner said the fact that patients stopped feeling depressed when they stopped the drug made “those safety signals more credible.”
However, suicidal thoughts among those taking these medications appear to be extremely rare.
Overall, reports of suicidal thoughts or feelings were rare, accounting for less than 0.02 percent of the system’s 14,000 reports.
Of the 265 reports of suicidal thoughts and mental health problems reported by Ozempic, depression was the most common, accounting for 113, or nearly half, of the reports.
There were also 59 reports of suicidal ideation, while six attempted suicide with the drug.
There were also four reports of suicides in patients taking Ozempic.
Millions of Americans now take Ozempic, and doctors are on the lookout for any rare side effects that may have gone undetected in clinical trials.
In 2022, more than 5 million prescriptions for Ozempic, Mounjaro, Rybelsus or Wegovy for weight management were issued, compared to just over 230,000 in 2019. This marks an increase of more than 2,000 percent, according to the research firm Komodo Health market.
Among the patients who said the drug had made them suicidal was Dawn Heidlebaugh, a 53-year-old mother of four from Ohio.
Heidlebaugh, who works in real estate, revealed that she began taking the medication every Sunday and by Tuesday felt lethargic, depressed and at times suicidal, believing her family would be better off without her.
The symptoms would persist for a few days, he said, and then return shortly after the next injection. They just didn’t appear when you missed a dose.
Eric Turner, who previously worked as an FDA reviewer, said evidence of a link between Ozempic and suicide was becoming “more credible.”
Mrs Heidleberg, who had no history of depression, said: “I knew it was the drug.”
Another patient, Sarah Sobol, 40, from Buffalo, New York, revealed how Ozempic had left her with panic attacks, hallucinations and suicidal thoughts.
He had started taking it in 2021 to lose weight, but stopped after these side effects appeared.
Ms. Sobol said: “If someone had said, ‘This is a side effect; “You’re not losing your mind,” it would have helped me a lot.
‘I thought I would end up in the psychiatric ward. She was terrified that she would never be normal again.”
A third patient, Lisa Wood, 22, of North Carolina, who lost 70 pounds on the drug, also revealed that she had suicidal thoughts while taking Wegovy, Ozempic’s sister drug.
“I was driving and I thought, ‘What would happen if I just turned the wheel while I was on this bridge?’ “It didn’t occur to me that it was Wegovy.”
And a fourth patient, a 37-year-old nurse and mother of two from North Carolina who gave only her name Katherine, said she also had suicidal thoughts.
While at Wegovy, she said she repeatedly visualized herself shooting herself. One night, her symptoms got so bad that she went to the emergency room, where she was given anxiety medication.
A doctor told her: ‘You are a mother. This happens when you get too tired.’
Concerns about suicidal thoughts in patients taking Ozempic first emerged in July this year, when European regulators said they were investigating the possible link.
Several users also expressed concern on social media, saying they felt “empty” and that “rarely does anything make me happy.”
EU and UK regulators are expected to rule next month on links between medications and suicidal thoughts.
An FDA spokesman said it was evaluating reports and will decide whether to act after a thorough review.
Suicidal thoughts and depression are not listed as side effects of the hit weight-loss drug and there is no evidence that they can cause the disease.
The label for Wegovy, Ozempic’s sister drug, warns that suicidal thoughts have been reported with other weight loss medications and recommends that those who begin using the drug be monitored for these thoughts. This is required by the FDA because Wegovy has been approved as a weight loss medication.
But doctors are watching for rare side effects that may have gone undetected in clinical trials that included only tens of thousands of people. Millions of people now take weight loss medications.
In an earlier case, doctors linked rare fatal blood clots to the AstraZeneca Covid vaccine after it was administered to millions of people in Europe. The vaccine was never approved for use in the United States.
Doctors are following it closely because other weight-loss medications have also previously been linked to suicide.
In 2008, Sanofi’s weight-loss drug Acomplia was recalled in Europe after being linked to suicidal thoughts. It was never approved in the United States.
The weight loss drug Contrave carries a black box warning about suicidal thoughts, and another obesity drug, Qsymia, also has a warning telling patients to stop taking it if they experience suicidal thoughts.
Novo Nordisk, which makes Ozempic, has filed 180 of the 265 FDA reports describing suicidal thoughts or behavior.
Among the 113 available detailed case accounts seen by Reuters, 91 were submitted by the company.
However, in almost all of these cases, the company said there were too few details to determine what happened.
In three reports, he attempted to explain them away by saying that overweight people have a higher risk of depression or suicidal ideation.
Novo Nordisk has been contacted for comment.