Bariatric Journal
Bariatric Journal
Ozempic Alert!
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Ozempic Alert!

Safety Warning About GLP-1 Drugs!

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning about the potential side effects of weight-loss drugs known as glucagon-like peptide-1 receptor agonists (GLP-1RAs), urging healthcare professionals to inform patients of these risks.

Meanwhile, the House of Lords food, diet, and obesity committee has declared a public health emergency due to the high rates of obesity and diet-related diseases in the UK. The committee advocates for a comprehensive approach to address this crisis, including a tax on unhealthy foods, a ban on junk food advertising, and greater regulation of the food system. While weight-loss drugs are acknowledged as a potential tool, the committee emphasizes the need for broader societal interventions to combat the root causes of obesity.

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Background Information on GLP-1RAs

GLP-1 receptor agonists (GLP-1RAs) are used to treat type II diabetes and obesity. Approved options in the UK include dulaglutide, exenatide, liraglutide, lixisenatide, and semaglutide. Specific brands, such as Wegovy (semaglutide), are also approved to reduce cardiovascular risk in patients with heart disease. Another product, Mounjaro (tirzepatide), combines GLP-1RA with a GIP RA.

Growing interest in GLP-1RAs for weight loss has led to their use outside intended conditions, although benefits and risks for these applications remain unstudied. GLP-1RAs licensed for weight management are effective for patients with obesity or weight-related health issues but are intended only for those who meet these criteria.

Reports of adverse reactions include gastrointestinal symptoms, especially at treatment initiation or following dose increases. Severe cases of dehydration have led to hospitalizations, particularly in individuals who may not meet prescribing criteria but have used these drugs for unapproved weight-loss purposes. By October 2024, the MHRA received reports of gastrointestinal issues in users of GLP-1RAs for weight management, with 68 cases resulting in hospitalization. Limitations in reporting data mean the actual frequency of such reactions remains uncertain.

Adverse Drug Reaction Reporting

Healthcare professionals are encouraged to continue reporting ADRs through the Yellow Card scheme. Include detailed information, such as the patient’s medical history, co-medications, treatment dates, and any signs of misuse. This data supports the safe and effective use of GLP-1RAs.

Information for Patients

Prescription Use Only: GLP-1RAs are prescription medicines intended for medical supervision. They should only be prescribed by qualified healthcare professionals.

Risks and Benefits: Be aware that the risks and benefits of using GLP-1RAs for weight loss outside licensed indications have not been thoroughly studied.

Common Side Effects: The most frequent side effects are gastrointestinal (nausea, vomiting, diarrhea, constipation), affecting over 1 in 10 users. These can persist for several days and may cause dehydration, which, in severe cases, could lead to complications like kidney damage.

Staying Hydrated: To avoid dehydration, stay hydrated by drinking plenty of fluids, especially if you experience gastrointestinal side effects like vomiting or diarrhea.

Serious but Rare Side Effects: Less common but serious side effects include gallstone disease, pancreatitis, and severe allergic reactions.

Avoiding Counterfeit Products: If you receive a private prescription, ensure it’s filled by a legitimate pharmacy to avoid the risk of counterfeit products.

Reading and Following Instructions: Always follow the dosage and instructions provided in the Patient Information Leaflet. If you experience any side effects, consult a healthcare professional.

Guidance for Healthcare Professionals

Informing Patients of Side Effects: Educate patients at the start of their treatment and when increasing doses on the common gastrointestinal side effects of GLP-1RAs, which affect over 1 in 10 patients. While often mild, these effects can occasionally lead to severe dehydration and even hospitalization.

Hypoglycemia Awareness: Recognize that hypoglycemia can develop in non-diabetic patients using GLP-1RAs for weight management. Ensure patients understand the signs and symptoms of hypoglycemia and encourage them to seek medical advice immediately if they experience these symptoms.

Warning Against Falsified Medications: Advise patients of the risks associated with obtaining GLP-1RAs from unregistered sources, as some counterfeit versions contain insulin.

Potential for Misuse: Be mindful of reports of unauthorized use of GLP-1RAs, including aesthetic weight loss, and consider the implications of such misuse in patient counseling.

Adverse Drug Reaction Reporting: Report any suspected adverse drug reactions (ADRs) through the Yellow Card scheme to improve the safety and understanding of GLP-1RAs in real-world use.

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