2023-07-27 23:08:56
UK health authorities said on Wednesday they are reviewing obesity and diabetes drugs such as Novo Nordisk’s Wegovy and Ozempic following some patients taking the treatments reported thoughts of suicide or self-harm.
The research into life-threatening side effects comes as the drugs’ popularity soars in the United States and attracts increased investor interest in helping people achieve dramatic weight loss.
In a statement to CNBC, the Medicines and Healthcare Products Regulatory Agency (MHRA) did not indicate when it expects to complete its review of the safety data on the treatments. European Union authorities launched a similar investigation into the drugs earlier this month.
The MHRA said the review includes all obesity and diabetes medicines available in the UK. In addition to Ozempic and Wegovy, it includes Novo Nordisk’s other weight loss drug, Saxenda. Other diabetes drugs such as AstraZeneca’s Bydureon, Eli Lilly’s Trulicity and Sanofi’s Lyxumia are also included in the investigation.
They are all part of a class of drugs known as GLP-1 receptor agonists, which mimic a hormone produced in the intestine to suppress a person’s appetite. GLP-1s may also help control type 2 diabetes because they stimulate the release of insulin from the pancreas, which lowers blood sugar levels.
“Patient safety is our top priority,” the MHRA said in the statement to CNBC. “We will carefully consider all available evidence and communicate any additional advice to patients and healthcare professionals, as appropriate.”
Novo Nordisk said in a statement that it received a review request from the MHRA on Monday. The company added that “a response will be provided within the requested timeframes” of the review.
Sanofi said in a statement that it was aware of the review and that it works with the MHRA. The company added that its pharmacovigilance monitoring system, which tracks adverse drug effects, has not identified any safety concerns associated with GLP-1s.
AstraZeneca and Eli Lilly did not immediately respond to a request for comment on the MHRA review. Archyde.com was first to report on the review.
Between 2020 and July 6 this year, the MHRA received five reports of suspected adverse drug reactions associated with “suicidal and self-injurious” behavior in patients taking Ozempic and Wegovy.
The agency also received 12 similar reports involving people who took Saxenda, or liraglutide, between 2010 and July 6.
But the MHRA stressed that those reports are not proof that the drugs caused those adverse reactions.
The US prescribing information for Wegovy and Saxenda, both approved by the Food and Drug Administration (FDA), already recommends that health care providers monitor “suicidal ideation and behavior.”
The Saxenda data also noted that clinical trials in adults found that 9 of 3,300 people taking the drug reported suicidal ideation. That compares to 2 out of more than 1,900 people with a placebo. The prescribing information says that “there was insufficient information to establish a causal relationship” between suicidal ideation and Saxenda.
There is no similar recommendation in the US prescribing information for Ozempic and other GLP-1 for diabetes, which are generally used at lower doses.
If you are having suicidal thoughts, contact the LifelineSuicide & Crisis Lifeline in the USA at 988 or with Samaritans in the UK on 116 123.
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