Patients taking Ozempic should seek immediate medical attention (by calling 999 or attending A&E) if they experience: Signs of a severe allergic reaction , including difficulty breathing, swelling of the face, lips, tongue or throat, or severe skin rash Severe hypoglycaemia with inability to swallow, seizures or loss of consciousness (particularly relevant for those on insulin or sulfonylureas) Ongoing seizures or loss of consciousness Patients should contact their GP or NHS 111 urgently if they experience: Severe, persistent abdominal pain that may radiate to the back, potentially indicating pancreatitis stop taking Ozempic and seek urgent assessment Persistent vomiting or diarrhoea lasting more than 24 hours, which may lead to dehydration Symptoms of dehydration , such as extreme thirst, very dark urine, dizziness on standing, or reduced urine output Visual changes , particularly if they have pre-existing diabetic retinopathy Signs of gallbladder problems , such as pain in the upper right abdomen, fever, or yellowing of the skin or eyes For hypoglycaemia (blood glucose below 4 mmol/L): [19] [20] Take fast-acting carbohydrates (e.g., glucose tablets, fruit juice) Follow with longer-acting carbohydrates once symptoms improve Seek medical help if symptoms don't improve or recur Have someone call 999 if unable to swallow or if unconscious Routine follow-up with the prescribing clinician should occur if: Gastrointestinal side effects persist beyond the first few weeks or significantly impact quality of life There are concerns about medication effectiveness or blood glucose control New medications are started that might interact with Ozempic There are questions about injection technique or dose adjustments Patients should never stop Ozempic abruptly without medical guidance, as this may lead to deterioration in glycaemic control
The NDA is based on results from REDEFINE 1, a 68-week, phase 3, randomised, double-blind, placebo-and active-controlled trial that evaluated the efficacy and safety of once-weekly, CagriSema compared to semaglutide 2.4 mg alone, cagrilintide 2.4 mg alone, or placebo, all as an adjunct to lifestyle intervention in 3,417 adults with obesity (BMI 30 kg/m2) or overweight (BMI 27 kg/m2) with one or more obesity-related complications and without diabetes, and REDEFINE 2, a double-blind, randomised, placebo-controlled, 68-week, phase 3 trial that evaluated the efficacy and safety of once-weekly CagriSema versus placebo, as an adjunct to lifestyle intervention in 1,206 adults with type 2 diabetes and either obesity (BMI 30 kg/m2) or overweight (BMI 27 kg/m2)
Helpful details include weight history, current BMI if known, waist circumference, previous diets or programs, exercise limitations, medications, supplements, recent lab results, family history, and personal health goals
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