Ozempic and Wegovy are being investigated for suicide risk

Weight loss drugs including Wegovy and Saxenda are being reviewed by Europe’s drugs regulator over a possible connection to thoughts of suicide and self-harm among users. Ozempic, which is approved as diabetes medication but often used off-label for weight loss due to its appetite curbing side-effects, is also being included in the review.

The European Medicines Agency was alerted to the potential link by Iceland following three cases, the BBC reports. As a result, the regulator’s Pharmacovigilance Risk Assessment Committee will investigate medication that contains either semaglutide or liraglutide. It will also consider whether other similar drugs – in the broader category of glucagon-like peptide-1 (GLP-1) receptor agonists – also need to be assessed for risks.

“The review is being carried out in the context of a signal procedure raised by the Icelandic Medicines Agency, following three case reports. A signal is information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation,” an EMA official told the BBC. “The case reports included two cases of suicidal thoughts – one following the use of Saxenda and one after Ozempic. One additional case reported thoughts of self-injury with Saxenda.”

While the medicines do already list suicidal thoughts and depression as a possible side effect, suicidal behaviour is not currently included. Other potential side effects of semaglutide drugs can be nausea, dizziness, constipation, vomiting and diarrhoea.

A representative of the manufacturer of Wegovy and Ozempic, Novo Nordisk, said it is working with the EMA and that patient safety is a top priority. “GLP-1 receptor agonists have been used to treat type-2 diabetes for more than 15 years and for treatment of obesity for eight years, including Novo Nordisk products such as semaglutide and liraglutide that have been in the UK market since 2018 and 2009 respectively,” the said. “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.”

The UK’s drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), said it was monitoring the situation.

Semaglutide is used to treat type 2 diabetes by helping to regulate blood sugar levels by mimicking the action of glucagon-like peptide-1 (GLP-1). It also greatly suppresses appetite and slows the rate at which the stomach empties, which has led to its use as a weight-loss drug. Saxenda and Wegovy are approved and licensed for weight loss, while Ozempic is currently only approved for diabetes. In the UK, Wegovy is not yet available but last month the prime minister announced plans for GPs to start offering it to NHS patients.

A pill form of semaglutide is also currently being developed. Pharmaceutical companies are racing to be the first to market with the oral version of the drug as doctors believe it will be more palatable to people than injections. There is big money to be made from this: Ozempic is forecast to have 2023 sales of $12.5 billion and up to $17bn in 2029. It accounts for 98 percent of Novo Nordisk’s 42 percent overall growth last year. While the pill might entice more people to take semaglutide, however, the higher dose does mean there are more side effects. In a trial conducted by Novo Nordisk on obese and overweight participants without diabetes, 80 percent reported gastrointestinal issues like vomiting, nausea, constipation or diarrhoea. 

Since the weight-loss effects of semaglutide have become known to the public, the drug  – and its branded names including Ozempic and Wegovy – has come to dominate the cultural conversation and become so popular there is currently a national shortage, and even people with diabetes are struggling to get their hands on it. But while the drug is being heralded by some as “silver-bullet” weight loss miracle, there seem to be many physical and emotional side effects that come with taking semaglutide. 

In June, Professor Jens Juul Holst, a scientist whose work in the 1970s helped pioneer Ozempic, warned that people will struggle to take it for more than a few years because it takes the pleasure out of eating. “Once you’ve been on this for a year or two, life is so miserably boring that you can’t stand it any longer and you have to go back to your old life,” he said. 

On a wider cultural level, the popularity of the drug has exposed how prevalent fatphobia still is and that, despite all the work movements like body positivity have done, extreme thinness above all else remains the beauty ideal.

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