Some people are overdosing from certain products marketed for weight loss, federal health officials are warning.
The FDA has received reports of dosing errors involving compounded semaglutide injectable products dispensed in multiple-dose vials, resulting in patients seeking medical attention or requiring hospitalization, the agency stated.
Dosing errors came as a result of people measuring and self-administering incorrect amounts, and health care providers miscalculating doses of the cheaper, compounded versions of weight-loss drugs like Wegovy, the agency said Friday in an alert.
Overdose symptoms include nausea, vomiting, abdominal pain, fainting, headache, migraine, dehydration, acute pancreatitis and gallstones, according to the FDA.
A majority of the reports had patients mistakenly drawing up more than the prescribed dose from a multiple-dose vial, self-administering five to 20 times more than the intended dose of semaglutide. Many reports involved patients unfamiliar with how to measure the intended dose using a syringe.
U.S. Food and Drug Administration
Confusion between different units of measurement including milliliters and milligrams may have contributed to the dosing mistakes, the FDA said.
One provider meant to dose 0.25 milligrams, or 5 units, but prescribed 25 units instead, leading to a patient getting five times the intended dose and experiencing severe vomiting, the FDA relayed. Another provider prescribed 20 units instead of 2, affecting three patients who, after receiving 10 times the intended dose, experienced nausea and vomiting.
There are currently three FDA-approved semaglutide products: Ozempic and Wegovy injections and Rybelsus tablets.
Typically offered by online pharmacies, compounded semaglutide products come in various containers and packaging, including multiple-dose vials and prefilled syringes, the agency noted.
Compounded drugs pose a higher risk to patients than those approved by the FDA, and should only be used when a person’s medical needs can’t be met by an available FDA-approved drug, the agency stated in its alert.
