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August 15, 2024
On July 26, 2024, the Food and Drug Administration (FDA) issued a compounding risk alert about dosing errors associated with compounded injectable semaglutide products that are marketed for type 2 diabetes or weight loss. There is a risk of adverse events, some requiring medical attention or hospitalization, including overdoses due to dosing errors. The FDA warned that people who receive vials of compounded semaglutide may lack experience with self-injections, including...
August 15, 2024
On July 26, 2024, the Food and Drug Administration (FDA) issued a compounding risk alert about dosing errors associated with compounded injectable semaglutide products that are marketed for type 2 diabetes or weight loss. There is a risk of adverse events, some requiring medical attention or hospitalization, including overdoses due to dosing errors. The FDA warned that people who receive vials of compounded semaglutide may lack experience with self-injections, including unfamiliarity with transferring medicine from a vial into a syringe, and may be confused by the different units of measurement, such as milliliters, milligrams and “units.” As semaglutide injection is currently “in shortage,” compounders are allowed to prepare versions of the drug consistent with FDA regulations.
People who are considering these products should know that the FDA does not review compounded versions of semaglutide for safety, effectiveness or quality; these drugs pose a higher risk to patients than FDA-approved drugs.
Semaglutide is in a class of medications known as glucagon-like peptide (GLP-1) receptor agonists. As of August 2024, the FDA had approved three semaglutide products; there are no approved generic versions.
WEGOVY is available as single-dose pre-filled pens that deliver a preset dose for once-weekly dosing by injection. The FDA has approved Wegovy, in combination with a reduced-calorie diet and increased physical activity, to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight. The drug also is approved for reduction of body weight and maintenance of weight reduction in patients aged 12 and older with obesity and for adults with overweight and at least one weight-related comorbid condition, such as dyslipidemia or hypertension.
OZEMPIC is available as multiple-dose pre-filled pens for single-patient use and designed for once-weekly dosing by injection. The FDA has approved Ozempic as an adjunct to diet and exercise for adults with type 2 diabetes and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease.
RYBELSUS is available as oral tablets for daily dosing and approved as an adjunct to diet and exercise for adults with type 2 diabetes.
The reports of dosing errors involved “compounded semaglutide injectable products dispensed in multiple-dose vials,” according to the alert. Adverse events included “gastrointestinal effects (e.g., nausea, vomiting, abdominal pain), fainting, headache, migraine, dehydration, acute pancreatitis and gallstones.” Because semaglutide has a long half-life in the body (about a week), overdose symptoms may require a prolonged period of observation and treatment.
Some dosing errors are related to incorrect measurement of the intended dose; others are related to miscalculation of the intended dose. Unlike the FDA-approved products, compounded injectable semaglutide products are offered in various packaging, containers and concentrations, leading to confusion for both patients and clinicians.
GLP-1 receptor agonists should only be used under medical supervision and in the context of an overall assessment of an individual’s health, available alternatives and full consideration of the risks and benefits of these medications over time. Moreover, as the alert emphasized, “compounded drugs should only be used for patients whose medical needs cannot be met by an available FDA-approved drug.” Compounded drugs have no advantages in meeting the medical needs of patients who may be prescribed GLP-1 receptor agonists.
Report any adverse events associated with compounded injectable semaglutide products to the FDA’s MedWatch program by calling 1-888-463-6332 or going to https://www.fda.gov/MedWatch.
To see the FDA’s alert, visit the following link: https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-patients-dosing-errors-associated-compounded.
