FDA release statement exercising caution around dosing errors associated with compounded injectable semaglutide products
Natalia Elliot | July 31, 2024 | News story | Media Relations, Medical Communications, Pharmacovigilance, US Healthcare & Trade Press | FDA, Gastrointestinal tract, compunded injectable, dosage, hospitalisation, pharmaceutical, warning
This week, the US Food and Drug Administration (FDA) and have issued warnings regarding dosing errors associated with compounded injectable semaglutide products (Ozempic).
Some patients have sought medical attention or required hospitalisation after mistakenly drawing up an incorrect dosage for the medication. Adverse events included gastrointestinal effects (eg, nausea, vomiting, abdominal pain), fainting, headache, migraine, dehydration, acute pancreatitis and gallstones.
The majority of reports claim that patients were administering five to 20 times more than the intended dosage. The reports also claim a lack of familiarity around how to measure the intended dose using a syringe.
The FDA recognises the substantial consumer interest in using compounded semaglutide products such as Ozempic for weight loss.
However, compounded drugs do not undergo FDA premarket review for safety, effectiveness or quality, posing a higher risk to patients. Therefore, compounded drugs should only be used to meet a patient’s needs if the patient’s medical needs cannot be met by an available FDA-approved drug.
The FDA recommends that all healthcare providers remain vigilant while prescribing and administering compounded semaglutide due to an availability of different concentrations.
Additionally, they encourage patients who have been prescribed compounded semaglutide to speak to their healthcare provider or compounder and clarify how to measure and administer their intended dose.
The FDA have added that they are “aware that some compounders incorporate additional ingredients, such as cyanocobalamin (Vitamin B-12), pyridoxine (Vitamin B-6), levocarnitine (L-Carnitine) and nicotinamide adenine dinucleotide (NAD), into their semaglutide products. The safety and effectiveness of combining semaglutide with other ingredients has not been established.”
More additional information includes: “The FDA had also received reports that in some cases, compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate. The salt forms are different active ingredients than is used in the approved drugs, which contain the base form of semaglutide. The FDA is not aware of any basis for compounding using the salt forms that would meet the FD&C Act conditions for types of active ingredients that can be used in compounding.”
For more information, including how to report symptoms, visit: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
Natalia Elliot
31/7/24
Related Content
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
Alto Neuroscience’s schizophrenia treatment granted FDA Fast Track designation
Alto Neuroscience has announced that its investigational treatment for cognitive impairment associated with schizophrenia (CIAS) …
FDA approves Moderna’s updated COVID-19 vaccines targeting new variant
The US Food and Drug Administration (FDA) has approved Moderna’s updated COVID-19 vaccines, Spikevax and …
