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The EMA’s safety committee has said that, after a review of available data, it has found no evidence that GLP-1 agonist drugs such as Novo Nordisk’s Ozempic and Eli Lilly’s Trulicity can cause cancer of the thyroid.
Six months ago, the Pharmacovigilance Risk Assessment Committee (PRAC) started a review of the class – used to treat type 2 diabetes and obesity – after seeing cases of this type of cancer in diabetic patients taking the drugs.
The review looked at patients taking Ozempic and obesity therapy Wegovy, both based on semaglutide, as well as Trulicity (dulaglutide), Novo Nordisk’s short-acting GLP-1 Victoza (liraglutide), AstraZeneca’s Byetta/Bydureon (exenatide), and Sanofi’s Lyxumia (lixisenatide).
The EMA, as well as the FDA in the US, have approved labelling for Wegovy that mentions that semaglutide has been shown to cause thyroid tumours in rodents, and the US regulator has said the drug should not be used in people with a family history of thyroid cancer.
In a statement, the EMA said the PRAC reviewed evidence from the published literature, including observational studies, as well as data submitted by the marketing authorisation holders (MAHs), which included non-clinical, clinical, and post-marketing data.
From that, the PRAC has concluded that the data “does not support a causal association” between the drugs and thyroid cancer and sees no need to update the product information at this time.
The MAHs should, however, “continue to monitor these events closely, including any new publications, as part of their pharmacovigilance activities and report any new evidence on this issue in their Periodic Safety Update Reports (PSURs),” said the EMA.
The PRAC still has another safety review on the go for the GLP-1 class, however, exploring around 150 cases of suicide or self-harm among people treated with the drugs. The MHRA in the UK is also running an investigation into that safety signal, which was first flagged by the Icelandic medicines agency following reports of suicidal thoughts and self-injury in people using liraglutide and semaglutide medicines.
The cases related mainly to Wegovy and Novo Nordisk’s Saxenda formulation of liraglutide, also used to treat obesity. Both of those drugs already carry warnings about suicidal thoughts and behaviour on their labels in the US and highlight the need to monitor patients taking them for signs of emerging or worsening depression. The labels for diabetes therapies Ozempic and Trulicity don’t include that warning.
Novo Nordisk and Lilly, meanwhile, are also being sued by a woman in the US who claims they failed to warn of severe gastrointestinal side effects that can be caused by Ozempic and Mounjaro (tirzepatide), Lilly’s dual GLP-1/GIP agonist.