Key Takeaway:
- 216 suspected deaths and more than 158,000 adverse reaction reports have been submitted to the UK’s MHRA for three popular GLP-1 weight-loss drugs.
- The MHRA says the reports do not prove the medicines caused the deaths or side effects, and their safety remains under continuous review.
- Regulators maintain that the benefits of GLP-1 medicines outweigh the risks when they are used as approved and under medical supervision.
Hundreds of suspected deaths and more than 158,000 adverse reactions linked to popular weight-loss medications have been reported to the U.K.’s medicines regulator, which says the reports do not establish that the drugs caused the events.
MHRA Reports Thousands of Suspected Adverse Reactions
The Medicines and Healthcare Products Regulatory Agency, or MHRA, said its Yellow Card Scheme has received 158,769 reports of suspected adverse reactions involving three widely used GLP-1 receptor agonists prescribed for weight loss and diabetes.widely used GLP-1 weight-loss drugs prescribed for weight loss and diabetes.
According to the regulator’s latest data, tirzepatide, sold as Mounjaro, accounted for 106,189 suspected adverse reactions and 120 reported deaths. Semaglutide, the active ingredient in Wegovy and diabetes drugs Ozempic and Rybelsus, was linked to 48,089 suspected reactions and 59 reported deaths.
Liraglutide, marketed as Saxenda for weight loss and under other brand names for diabetes, was associated with 4,491 suspected adverse reactions and 37 reported deaths.
The MHRA said anyone who suspects a GLP-1 weight-loss drug or any other medicine has caused an adverse reaction can submit a report through its Yellow Card Scheme.
Regulator Says Reports Do Not Prove Cause of Death
The agency emphasized that reports submitted to the Yellow Card Scheme represent suspected links and should not be interpreted as proof that a medicine caused a death or adverse reaction.
“It is important to place these reports in the context of the millions of GLP-1 weight-loss drugs prescriptions issued in the UK,” an MHRA spokesperson said.
The spokesperson added that reporting levels may rise because of increased prescribing, greater awareness of potential side effects and other factors. The agency said it continues to review safety data from adverse event reports and scientific research.
“Based on the current evidence, the benefits of GLP-1 weight-loss drugs outweigh the potential risks when used in line with their authorised uses,” the spokesperson said.
The MHRA said it would promptly communicate any new safety findings to patients and health care professionals and take action if new risks are identified.
Government Says Safety Monitoring Continues
Health Secretary Yvette Cooper said the United Kingdom’s health safety system is designed to detect and monitor possible risks associated with medicines.
Speaking to LBC Radio, Cooper said experts continuously assess adverse event reports and safety concerns collected through the National Health Service.
“We have a whole system of health safety regulations in place where experts will do monitoring of any adverse impacts, of any safety reports, any concerns that are raised,” Cooper said.
She said centralized reporting through the NHS allows regulators to identify broader safety issues and ensure concerns are communicated to health ministers and the public when necessary.
GLP-1 weight-loss drugs have become increasingly popular for treating obesity and Type 2 diabetes. Commonly reported side effects include gastrointestinal symptoms, while regulators continue to monitor the medicines for any emerging safety concerns through ongoing surveillance.
