HQ Team
July 29, 2024: Overdose of weight-loss drugs and dosing errors by patients and healthcare providers have led to adverse events, including hospitalisation, the USFDA warned.
Many patients who received vials of compounded semaglutide lacked experience with self-injections, according to the adverse event reports of the FDA.
Unfamiliarity with withdrawing medication from a vial into a syringe coupled with confusion between different units of measurement such as millilitres, milligrams and ‘units’ may have contributed to dosing errors, according to an FDA statement.
In these instances, patients administered five to 20 times more than the intended dose of semaglutide. Most of the reports indicated that patients were unfamiliar with how to measure the intended dose using a syringe.
Pre-filled syringes
Patients must talk with their healthcare provider or compounder about how to measure and administer the intended dose of compounded semaglutide, the main ingredient in the injection.
There are various ways compounded semaglutide products may differ from approved products which may contribute to potential medication errors. according to the FDA.
“For example, FDA is aware that compounders offer semaglutide injectable products in various containers and packaging, including multiple-dose vials and prefilled syringes.”
Product concentrations also may vary depending on the compounder, and a single compounder may offer multiple concentrations of compounded semaglutide products.
“FDA is aware of compounded semaglutide products that are being marketed for weight loss.
“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.”
Gastrointestinal effects
The drug regulator urged healthcare providers and compounders to provide patients with the appropriate syringe size for the intended dose and counsel patients on how to measure the intended dose using the syringe.
Semaglutide overdose adverse events include gastrointestinal effects such as nausea, vomiting, abdominal pain, and others — fainting, headache, migraine, dehydration, acute pancreatitis, gallstones and severe hypoglycemia or low blood sugar levels.
Semaglutide belongs to a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists. There are currently three FDA-approved semaglutide products.
It includes Novo Nordisk’s Wegovy as a single-dose pre-filled pens that deliver a preset dose for once-weekly dosing and the company’s Ozempic — a multiple-dose pre-filled pen for single-patient use, designed for once-weekly dosing.
The Danish company’s oral tablet Rybelsus is also approved by the FDA for daily dosing.
A prolonged period of observation and treatment for overdose symptoms may be necessary due to the long half-life of semaglutide of about one week, according to the FDA statement.
