Warning Issued by FDA Regarding Overdosing on Compounded Semaglutide
The U.S. Food and Drug Administration (FDA) has recently issued a new warning regarding a popular weight loss medication, compounded semaglutide. The FDA has received reports of individuals overdosing on the medication, taking as much as 20 times the intended dose. Some of these cases have resulted in hospitalization.
The overdosing incidents primarily involve semaglutide that is drawn from a vial and administered via injection. The FDA has attributed these dosing errors to both patients incorrectly measuring and self-administering the medication and healthcare providers miscalculating the doses.
A key factor contributing to dosing errors is the lack of experience with self-injections among many patients who received vials of compounded semaglutide. The FDA highlights that unfamiliarity with withdrawing medication from a vial into a syringe, as well as confusion between different units of measurement, may have contributed to the dosing errors.
To address this issue, the FDA advises patients to consult with a medical professional to ensure they are measuring and administering the correct dose. Healthcare providers are urged to provide patients with the appropriate syringe size for the intended dose and offer guidance on how to measure the dose accurately using the syringe.
Semaglutide is the active ingredient in three FDA-approved medications: Wegovy, Ozempic, and Rybelsus. While the FDA-approved versions are available in the form of oral tablets or pre-filled pens, compounded semaglutide requires patients to draw the dose themselves from vials, creating the potential for dosing errors.
Symptoms of an overdose on compounded semaglutide include nausea, vomiting, abdominal pain, fainting, headache, migraine, dehydration, acute pancreatitis, and gallstones. Individuals experiencing these symptoms should contact their healthcare provider promptly.
The FDA also emphasizes the importance of reporting adverse events and medication errors to the agency. This can be done through the FDA’s online portal or by downloading and faxing an adverse event report.
It is worth noting that the FDA has previously expressed concerns about the use of compounded semaglutide. Compound pharmacies produce their own versions of semaglutide or tirzepatide using raw ingredients. These compounds differ from generic drugs, which undergo FDA approval and monitoring for safety and effectiveness.
Currently, there are no generic versions of semaglutide medications, such as Ozempic and Wegovy. The FDA advises against the use of compounded drugs when an approved drug is available. Patients and healthcare professionals should understand that the FDA does not review compounded versions of these drugs for safety, effectiveness, or quality.
The warning from the FDA came as many individuals turned to compounding pharmacies to obtain more affordable doses of semaglutide. Without insurance coverage, medications like Ozempic, Rybelsus, and Wegovy can cost over $1,000 a month.
While Ozempic and Rybelsus are FDA-approved for treating Type 2 diabetes, some doctors prescribe them off-label for weight loss, as permitted by the FDA. Wegovy, on the other hand, is FDA-approved specifically for weight loss in individuals with obesity or who are overweight with a comorbidity such as high blood pressure.
In conclusion, the FDA’s warning regarding overdosing on compounded semaglutide highlights the importance of proper dosage administration. Patients should seek guidance from healthcare professionals, and healthcare providers should ensure patients have the correct syringe size and understand how to measure the intended dose accurately. It is crucial to report any adverse events or medication errors to the FDA. Additionally, patients should be aware of the risks associated with compounded drugs and consider FDA-approved alternatives when available.
