New York City, the United States – Ray Niscior of Toledo, Ohio, has struggled with his weight since he was a child.

“I remember shopping in the husky clothes section with my mom as a kid,” Niscior told Al Jazeera. “I was bullied as the fat kid in school.”

Even when Niscior went to the military, he struggled to slim down.

“I was on the heavier side in the Navy, even after boot camp,” he said.

For Niscior, the arrival of Ozempic, touted as a weight-loss wonder drug, seemed like a game-changer.

Taking the diabetes medication together with an improved diet and exercise, he lost more than nine kilogrammes (20lbs) of the 36kg (80lbs) he put on after leaving the Navy.

Niscior’s joy, however, was short-lived.

Niscior, who suffers from ADHD and chronic depression, found that his mental health took a sharp turn for the worse while on Ozempic.

“I started Ozempic and it was almost like progress that I was making in therapy and all that kind of stuff sort of stalled,” Niscior said.

Niscior said his mental state only worsened as his dosage of Ozempic increased.

“I just had a lot of hopelessness,” he said. “I had a lot of suicidal ideation, which I had never had before. I have never, never once wanted to commit suicide. I had never once felt like I wanted to die.”

After going off the medication with the help of a mental health professional, Niscior’s mental health went back to normal.

Niscior’s experience is not the only such case.

Clinical trials

The US Food and Drug Administration (FDA) has received more than one thousand reports of adverse mental health side effects related to the class of drugs known as GLP-1 agonists to the FDA Adverse Event Reporting System (FAERS).

In March, the number of reports to the database stood at about 50.

Reports to FAERS have not been verified to determine causation but can provide a guide to potential trends deserving of follow-up study by medical authorities.

Both the FDA and Danish manufacturer Novo Nordisk have pointed out that neither Ozempic nor its sister weight-loss drug Wegovy have shown any increased risk of suicidal ideation or behaviour in clinical trials.

Neither of the drugs carry warnings about suicidal ideation in Europe or the United Kingdom, although regulators in both jurisdictions are investigating reports of adverse mental health effects.

In the US, Wegovy, which has been specifically approved for weight loss by the FDA, carries a warning to professionals to monitor for suicidal thoughts and discontinue the medication if necessary.

Ozempic, which is only FDA-approved to treat diabetes, does not carry such a warning.

Several studies are under way to assess the effects GLP-1 agonists may have on people with pre-existing mental health conditions.

Researchers at the University of Toronto are looking into the impact of the drugs on major depressive disorder, while a team at the University of Copenhagen is examining the effect on schizophrenia.

“The safety data collected from large clinical trial programmes and post-marketing surveillance have not demonstrated a causal association between semaglutide or liraglutide and suicidal and self-harming thoughts,” a Novo Nordisk spokesperson told Al Jazeera.

“Novo Nordisk is continuously performing surveillance of the data from ongoing clinical trials and real-world use of its products and collaborates closely with the authorities to ensure patient safety and adequate information to healthcare professionals.”

Ozempic and Wegovy, which contain the same active ingredient, semaglutide, have exploded in popularity over the past year.

Novo Nordisk reported that anti-obesity drug sales grew by 124 percent in the first quarter of 2023, with the bulk of those sales taking place in the North American market.

The drugs’ popularity has been aided by an aggressive marketing campaign by Novo Nordisk, which spent $11m on meals and travel for physicians in 2022 alone, as well as unofficial promotion by social media influencers, celebrities and media outlets worldwide.

Due to the financial success of semaglutide, it is no surprise that other pharmaceutical companies are trying to break into the market with the same zeal as Novo Nordisk.

“People are taking it in Hollywood. They are making an example of it, and that’s dangerous,” Daniela Beivide, chief science officer at London-based Holly Health, told Al Jazeera.

While Ozempic is only FDA-approved to treat Type 2 diabetes, it is widely prescribed off-label for weight loss.

Other drugs that have been used for weight loss, such as topiramate and sibutramine, have been linked to hypomanic and manic episodes in some studies.

Stacy McMartin of Everett, Washington, said her mental health suffered after she was prescribed Ozempic after gaining about 18kg (40 pounds) while on medication for bipolar disorder.

“My depression was out of whack. I lack motivation to do anything. I didn’t change clothes for three days, and I just want[ed] to lay around and do nothing but exist,” McMartin told Al Jazeera.

“My depression got worse. Then came the suicidal ideation and feeling like I was worthless. My family would be better off without me. My son would be better off without me.”

McMartin said those feelings went away after she stopped taking the drug.

On social media platforms like Reddit, hundreds of others have recounted similar experiences. Some notable influencers have weighed in with negative stories, including YouTube star CelinaSpookyBoo.

Concerns about potential side effects have been compounded by the reported ease with which some patients have been able to access weight-loss drugs without proper medical oversight.

Some compounding pharmacies, medical spas and weight loss clinics are advertising generic versions of the drug containing semaglutide sodium, a different active ingredient that is not used in any FDA-approved medication.

Some sellers are offering generic versions without even the need for a consultation or prescription.

Al Jazeera was able to order a generic version online with Vitastir Health, a Michigan-based provider of injectable vitamins and IV therapy, without ever talking to a doctor.

In the order confirmation, Vitastir said that a physician may call if he or she has “further questions on the medical information you submitted”, but “not all patients require a phone consultation”.

Vitastir did not respond to a request for comment.

Kishore M. Gadde, a professor at the University of California School of Medicine who specialises in both weight-related disorders and psychiatry, said he has seen such cases firsthand.

He described an encounter with a patient who had obtained Ozempic from a weight loss shop in California.

“I asked where is this? In an Ozempic pen? No. She pulled out her purse and showed me an insulin syringe. It’s a generic insulin syringe that you buy,” Gadde told Al Jazeera.

“She said they gave her four syringes filled with Ozempic, plus they added [vitamin] B12 to it.”

“I was just stunned,” he added.

In June, Novo Nordisk called on clinics and online pharmacies to stop the “sales of non-FDA approved counterfeit and compounded semaglutide products claiming to contain semaglutide”.

The FDA has warned that such sellers may be using salt forms of semaglutide that “are different active ingredients than the approved drugs”.

Nevertheless, the steep price tags of the drugs – Ozempic costs an average of $936 for a 30-day supply in the US – means that some people feel tempted to turn to unregulated vendors, including online sellers on platforms such as Reddit and Telegram.

“We need more regulation,” said Holly Health’s Beivide. “I understand that some people may actually benefit from the drug, but not everyone.”

With people who could have serious reactions like Niscior and McMartin, Beivide argues it is time to introduce safeguards to make sure the drugs only get into the hands of those who really need them.

“We need not to glorify any medication and regard it as a miracle cure for everyone because that’s never the case,” Beivide said. (Al Jazeera)

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