Packages of the weight-loss drug Wegovy from the pharmaceutical company Novo Nordisk lie on the sales counter in a Danish pharmacy.
Stefan Trumpf | Picture Alliance | Getty Images
U.K. health authorities on Wednesday said they’re reviewing obesity and diabetes drugs like Novo Nordisk‘s Wegovy and Ozempic after some patients who took the treatments reported thoughts of suicide or self-harm.
The probe into potentially life-threatening negative effects comes because the drugs skyrocket in popularity within the U.S. — and draw heightened investor interest — for helping people achieve dramatic weight reduction over time.
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The Medicines and Healthcare products Regulatory Agency, in an announcement to CNBC, didn’t indicate when it expects to finish its review of safety data on the treatments. Authorities within the European Union launched an identical investigation of the drugs earlier this month.
The MHRA said the review includes all obesity and diabetes drugs available within the U.K. Other than Ozempic and Wegovy, it includes Novo Nordisk’s other weight reduction drug Saxenda. Other diabetes drugs like AstraZeneca‘s Bydureon, Eli Lilly‘s Trulicity and Sanofi‘s Lyxumia are also included within the probe.
Those drugs are all a part of a category of medicine generally known as GLP-1 receptor agonists, which mimic a hormone produced within the gut to suppress an individual’s appetite. GLP-1s can even help manage Type 2 diabetes because they encourage insulin release from the pancreas, lowering blood sugar levels.
“Patient safety is our top priority,” the MHRA said in an announcement to CNBC. “We are going to fastidiously consider all available evidence and communicate any further advice to patients and healthcare professionals as appropriate.”
Novo Nordisk said in an announcement that it received a review request from the MHRA on Monday. The corporate said a “response will probably be provided inside the requested timelines” of the review.
Sanofi said in an announcement that it was aware of the review and is working with the MHRA. The corporate added that its pharmacovigilance monitoring system, which tracks hostile drug effects, has not identified any safety concerns related to GLP-1s.
AstraZeneca and Eli Lilly didn’t immediately reply to a request for comment on the MHRA’s review. Reuters first reported the review.Â
Between 2020 and July 6 this 12 months, the MHRA received five reports of suspected hostile drug reactions related to “suicidal and self-injurious” behavior in patients who took Ozempic and Wegovy.Â
The agency also received 12 similar reports involving those that took Saxenda, or liraglutide, between 2010 and July 6.Â
However the MHRA emphasized that those reports are usually not proof that the drugs caused those hostile reactions.Â
The U.S. prescribing information for Wegovy and Saxenda, each approved by the Food and Drug Administration, already recommends that health-care providers monitor for “suicidal behavior and ideation.”Â
Saxenda’s information also noted that clinical trials in adults found 9 of three,300 people on the drug reported suicidal ideation. That is compared with 2 of greater than 1,900 people on a placebo. The prescribing information says “there was insufficient information to determine a causal relationship” between suicidal ideation and Saxenda.
There isn’t a similar suggestion within the U.S. prescribing information for Ozempic and other GLP-1s for diabetes, that are typically used at lower doses.
For those who are having suicidal thoughts, contact the Suicide & Crisis Lifeline within the U.S. at 988 or the Samaritans within the U.K. at 116 123.
