Miss a day, miss a lot. Subscribe to The Defender's Top News of the Day. It's free.
European regulators are reviewing several popular weight-loss drugs like Ozempic for reportedly inducing suicidal thoughts among some users, according to a BBC News report.
Iceland’s health watchdog agency first flagged the problem, reporting at least two incidents of suicidal thoughts linked to Novo Nordisk’s Ozempic and Saxenda, and one case of self-harm ideation to Saxenda.
The European Medicines Agency (EMA) is investigating the reports.
The EMA said it will investigate weight-loss medications that contain either semaglutide or liraglutide, but that it may expand the probe to other drugs in the same class, known as GLP-1 receptor agonists, a spokesperson told the BBC.
GLP-1 receptor agonists originally were used to treat Type 2 diabetes, but are now being developed to treat obesity.
Novo Nordisk’s latest hit weight-loss drug, Wegovy, also uses semaglutide, and Eli Lilly, Amgen and Pfizer are developing GLP-1 receptor agonists.
The drugs under review carry an extensive list of side effects. In U.S. labeling, the product information lists thoughts of suicide as a possible side effect, but the European Union product information does not.
This review was announced just weeks after the EMA raised a thyroid cancer safety signal for several drugs in the GLP-1 class, including Novo’s semaglutide products and weight-loss drugs made by AstraZeneca and Sanofi.
Novo Nordisk’s stock price was down 2.25% this morning after a similar fall Monday following the news of EMA’s investigation. Eli Lilly’s stock price was also down nearly 2.3%.
Weight loss drugs have a history of links to suicidal ideation
Novo Nordisk said in a statement that it takes all reports about adverse events from the use of its medications very seriously, that patient safety is a top priority and that it had found no “causal association” between suicidal thoughts and the drugs.
Commenting on the EMA investigation, a U.S. Food and Drug Administration (FDA) spokesperson told Bloomberg News, “If newly identified safety signals are identified, the FDA will determine what actions are appropriate after a thorough review of the body of evidence.”
The spokesperson said that clinical trials for Wegovy did not support an increased risk of suicidal ideation, but clinical trials for other weight-loss drugs had.
According to the FDA Adverse Events Reporting System (FAERS) Public Dashboard, there have been at least 60 reports of suicidal ideation since 2018 from patients on semaglutide or their healthcare providers, Reuters reported.
It also reported that in the clinical trials for Ozempic and Saxenda, Novo Nordisk excluded people with a history of psychiatric disorders or recent suicidal behavior.
CNN reported that in the clinical trials for Saxenda for adults, nine people out of 3,300 taking the drug reported suicidal ideation, compared with two of more than 1,900 who received a placebo.
One adult on Saxenda attempted suicide, the prescribing information says. In pediatric clinical trials, one of 125 taking Saxenda died by suicide. The prescribing information says “There was insufficient information to establish a causal relationship to Saxenda.”
In fact, the issue of suicidal thoughts linked to weight-loss drugs has been a major hurdle to the drug industry’s ability to develop lucrative weight-loss drugs.
Diet pills Contrave by Currax Pharmaceuticals and Qsymia by Vivus, approved in the U.S. in 2014 and 2012, respectively, also carry warnings on their labels about the increased risk of suicidal thoughts.
Wegovy craze slowing?
Since the FDA approved Wegovy, the drug has become a sensation, with celebrities and social media influencers routinely sharing before-and-after pics on Instagram and TikTok. This exposure is helping to fuel a massive new drug market that could be worth $100 billion a year for drug makers — with most profits going to early leaders Novo Nordisk and Eli Lilly.
Wegovy was so popular in the U.S. that there have been shortages, causing patients to turn to other pharmaceuticals — like Novo Nordisk’s Ozempic — that can be used off-label for weight loss and which have become equally popular.
While Saxenda and Wegovy are both approved and licensed for weight loss in the U.K., Wegovy is not yet available, though doctors in England may start offering it to some patients as part of a two-year National Health Service pilot program, the government announced in June.
Drugmakers aren’t the only ones profiting from weight-loss drugs. Telehealth companies have sprung up offering an online prescription for the drugs in just 15 minutes.
Some U.S. medical spas and compounding pharmacies have chased the profits as well, allegedly producing copycat drugs with semaglutide as the active ingredient. Novo Nordisk has filed lawsuits against them.
These drugs are not made for short-term use. Studies show that when people stop taking them, they regain much of the weight they lost, or potentially gain even more weight. Most people who start taking the drugs and want the effects to last will have to stay on them long-term.
But recent pharmacy claims data shows that most people who start taking Wegovy stop taking it within a year, some because of side effects and some because of the high cost of the drugs.
Semaglutide’s other known side effects
In addition to concerns about suicidal ideation and thoughts of self-harm, pancreatic cancer and other adverse effects linked to semaglutide are also becoming apparent.
Metabolic, nutritional, eye, renal, urinary and cardiac disorders were also reported.
In addition to thyroid cancer, researchers have raised concerns about the potential risk for pancreatic carcinoma associated with the drug.
A study of 25,617 people also found the use of GLP-1 receptor agonists yields a 3.5-fold increase in the rate of intestinal obstruction.
The FDA warns that use should be discontinued at least two months prior to pregnancy because it takes that long for the body to eliminate the drug.
Neither drug was studied in pregnant women in clinical trials. But in animal studies, when rats, rabbits and monkeys were treated with injectable semaglutide drugs, they experienced increased rates of miscarriage and their offspring were born smaller and had higher rates of birth defects.