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 meant quantity of semaglutide.
- To stop challenges with dosing errors and overdoses, the FDA encourages sufferers to speak to healthcare suppliers to make clear find out how to measure and administer right doses with a syringe.
- The FDA had beforehand issued a warning urging individuals to keep away from off-brand or compounded formulations of the favored semaglutide drugs Ozempic, Wegovy, and Rybelsus.
Semaglutide drugs like Ozempic, Wegovy, and Rybelsus, have change into the topic of a international scarcity, with demand for the trending medicine outstripping provide. In consequence, some individuals have turned to compounding pharmacies for variations of the diabetes and weight reduction drugs. Beforehand, Now the FDA is cautioneding customers that these off-label variations may doubtlessly be unsafe. Now, it’s alerting healthcare suppliers, compounders, and sufferers in regards to 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 not too long ago led to 5 to twenty instances greater than the meant dose of semaglutide.
“Unfamiliarity with withdrawing treatment from a vial right into a syringe and matched with confusion between completely different items of measurement (e.g., milliliters, milligrams and “items”) might 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 Might 31, 2023 titled “Medicines Containing Semaglutide Marketed for Sort 2 Diabetes or Weight Loss,” the FDA referenced “opposed occasion studies” related to some types of compounded semaglutide. Particularly, officers have referred to as out compounded variations which will include elements which are much like the energetic ingredient semaglutide however chemically completely different as a result of they’re in salt kind. 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 elements to make drugs 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 “presently 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, nonetheless.
What’s the distinction between semaglutide and semaglutide sodium?
Some compounding pharmacies have been dishing out variations of the treatment made with a distinct energetic ingredient referred to as semaglutide sodium. The FDA has referred to as out these variations specifically as doubtlessly unsafe.
“Sufferers must be conscious that some merchandise offered as ‘semaglutide’ might not include the identical energetic ingredient as FDA-approved semaglutide merchandise and stands out as the salt formulations,” the FDA wrote. “Merchandise containing these salts, corresponding to semaglutide sodium and semaglutide acetate, haven’t been proven to be protected and efficient.”
Adversarial occasions from some compounded types of semaglutide
The FDA famous that it has acquired opposed occasion studies after sufferers used compounded semaglutide, and inspired the general public to report any further opposed occasions to the FDA via the MedWatch Adversarial Occasion Reporting Program.
“FDA has acquired studies that in some circumstances, compounders could also be utilizing salt types of semaglutide, together with semaglutide sodium and semaglutide acetate. The salt varieties are completely different energetic elements than is [sic] used [in] the permitted medicine, which include the bottom type of semaglutide. The company just isn’t conscious of any foundation for compounding utilizing the salt varieties that may meet the FD&C necessities for varieties of energetic elements that may be compounded,” the FDA acknowledged.
Does a generic model of Wegovy, Ozempic, or Rybelsus exist?
In its assertion, the federal company emphasised that there are presently 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 permitted generic variations.”
“FDA just isn’t conscious of any foundation for compounding a drug utilizing semaglutide salts that may meet federal necessities,” the company added.
