WASHINGTON (dpa-AFX) - The Food and Drug Administration has issued a warning to people using compounded injectable semaglutide products, popularly used for weight loss treatment, after receiving reports of adverse events due to overdose.
The FDA noted that the dosing errors might have occurred due to self-administration of incorrect doses, lack of experience with self-injections, unfamiliarity with withdrawing drug from vials, and confusion regarding units of measurements.
According to the agency, over dosed patients suffered from fainting, headache, migraine, dehydration, acute pancreatitis and gallstones, and gastrointestinal effects such as nausea, vomiting, and abdominal pain.
The FDA urged patients to talk to healthcare providers or compounders regarding measurement and administration of the intended dose of compounded semaglutide, as the reports pointed out that patients had administered five to 20 times more than the intended dose of semaglutide..
'Compounded drugs pose a higher risk to patients than FDA-approved drugs because compounded drugs do not undergo FDA premarket review for safety, quality or effectiveness. Compounded drugs should only be used for patients whose medical needs cannot be met by an available FDA-approved drug', the agency said in a statement.
The FDA also advised healthcare providers and compounders to provide patients with appropriate syringe size for intended doses.
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