The FDA has given an update on its ongoing review of a possible link between GLP-1 agonist drugs used to treat diabetes and obesity and suicide, saying it can find no evidence that the risk is increased.
Along with other world regulators including the EMA, the FDA started its review of the safety of the fast-growing class last year after reports of suicidal thoughts or self-injury in a small number of patients taking them.
The probe was a scare for Novo Nordisk, which is leading the charge in the development and commercialisation of these drugs with products like Ozempic for diabetes and obesity therapy Wegovy, both based on GLP-1 drug semaglutide, along with other prominent players in the market like Eli Lilly.
The US agency said it has carried out “detailed reviews” of reports of suicidal thoughts or actions received in the FDA Adverse Event Reporting System (FAERS) but concluded there was no clear relationship with the use of the drugs.
It pointed out that information submitted on these events was “often limited” and that suicidal events can be influenced by many other factors.
Meanwhile, FDA is also carrying out a meta-analysis of all clinical trials of GLP-1 drugs, as well as post-marketing data on the drugs from its Sentinel pharmacovigilance system, and said it will “communicate our final conclusions and recommendations after we complete our review or have more information to share.”
In the US, suicidal thinking and self-harm aren’t currently listed on the FDA-approved prescribing information for Ozempic or as possible adverse reactions, but they are cited in the labelling for Wegovy as well as Novo Nordisk’s older GLP-1 agonist Saxenda (liraglutide).
That is a standard requirement for any drug used to achieve weight loss that works on the central nervous system, which partly stems from experience with an earlier Sanofi weight-loss drug called Acomplia/Zimulti (rimonabant).
That was approved in Europe in 2006, but withdrawn from sale two years later after the EMA concluded it was associated with a risk of serious psychiatric problems, including suicide. It was never approved by the FDA.
FDA stressed that patients should not stop taking their GLP-1 medication without first consulting with a healthcare professional.
The EMA’s review – which covered clinical and post-marketing data as well as a literature review – also found no clear evidence of a link when its findings were published last month although it said there were still some questions remaining and it had sought more information from GLP-1 manufacturers.
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