This content material initially appeared on diaTribe. Republished with permission.
By Susannah Chen
Key takeaways:
- The FDA issued an alert to healthcare suppliers, compound pharmacies, and sufferers about current overdoses related to compounded injectable semaglutide, resulting in the dosing of 5 to twenty instances greater than the supposed quantity of semaglutide.
- To stop challenges with dosing errors and overdoses, the FDA encourages sufferers to speak to healthcare suppliers to make clear tips on how to measure and administer right doses with a syringe.
- The FDA had beforehand issued a warning urging folks to keep away from off-brand or compounded formulations of the favored semaglutide medicines Ozempic, Wegovy, and Rybelsus.
Semaglutide medicines like Ozempic, Wegovy, and Rybelsus, have turn into the topic of a world scarcity, with demand for the trending medicine outstripping provide. Consequently, some folks have turned to compounding pharmacies for variations of the diabetes and weight reduction medicines. Beforehand, Now the FDA is cautioneding customers that these off-label variations may probably be unsafe. Now, it’s alerting healthcare suppliers, compounders, and sufferers concerning the risks of miscalculating dosage when administering injectable semaglutide.
FDA warns of dosing errors with compounded injectable semaglutide
In a assertion issued July 26, 2024, the FDA warned that affected person inexperience with measuring and self-administering injectable compound semaglutide merchandise has lately led to 5 to twenty instances greater than the supposed dose of semaglutide.
“Unfamiliarity with withdrawing medicine from a vial right into a syringe and paired with confusion between totally different items of measurement (e.g., milliliters, milligrams and “items”) could have contributed to dosing errors,” the FDA added. Each Ozempic and Wegovy are injectable semaglutide merchandise, whereas Rybelsus is an oral model of semaglutide.
In a earlier assertion issued Could 31, 2023 titled “Drugs Containing Semaglutide Marketed for Sort 2 Diabetes or Weight Loss,” the FDA referenced “hostile occasion reviews” related to some types of compounded semaglutide. Specifically, officers have referred to as out compounded variations that will include components which are just like the lively ingredient semaglutide however chemically totally different as a result of they’re in salt type. The company cautioned that it doesn’t evaluation these compounded semaglutide variations for security or efficacy.
What’s compounded semaglutide?
Compounded medicine are created by combining or altering components to make medicines tailered to the wants of a particular particular person. There are roughly 7,500 compound pharmacies within the U.S. When the FDA’s drug scarcity web site lists a drug as “at the moment in scarcity,” which is the case with semaglutide medicine Ozempic, Wegovy, and Rybelsus, then compounding pharmacies are permitted to purchase semaglutide from pharmaceutical ingredient producers, combine it with different compounds, and put together a model of the drug in the event that they meet sure necessities of the Federal Meals, Drug, and Beauty (FD&C) Act. The company doesn’t evaluation these compounded variations for security, effectiveness, or high quality, nevertheless.
What’s the distinction between semaglutide and semaglutide sodium?
Some compounding pharmacies have been shelling out variations of the medicine made with a unique lively ingredient referred to as semaglutide sodium. The FDA has referred to as out these variations particularly as probably unsafe.
“Sufferers must be conscious that some merchandise offered as ‘semaglutide’ could not include the identical lively ingredient as FDA-approved semaglutide merchandise and often is the salt formulations,” the FDA wrote. “Merchandise containing these salts, similar to semaglutide sodium and semaglutide acetate, haven’t been proven to be secure and efficient.”
Antagonistic occasions from some compounded types of semaglutide
The FDA famous that it has acquired hostile occasion reviews after sufferers used compounded semaglutide, and inspired the general public to report any extra hostile occasions to the FDA by the MedWatch Antagonistic Occasion Reporting Program.
“FDA has acquired reviews that in some instances, compounders could also be utilizing salt types of semaglutide, together with semaglutide sodium and semaglutide acetate. The salt varieties are totally different lively components than is [sic] used [in] the accredited medicine, which include the bottom type of semaglutide. The company is just not conscious of any foundation for compounding utilizing the salt varieties that might meet the FD&C necessities for varieties of lively components that may be compounded,” the FDA said.
Does a generic model of Wegovy, Ozempic, or Rybelsus exist?
In its assertion, the federal company emphasised that there are at the moment solely three FDA-approved semaglutide merchandise – Ozempic and Wegovy, that are injectables, and Rybelsus, which is an oral pill – all accessible solely with a prescription, and that “there are not any accredited generic variations.”
“FDA is just not conscious of any foundation for compounding a drug utilizing semaglutide salts that might meet federal necessities,” the company added.
