People are excited to use semaglutide, a diabetes drug popular for assisting weight loss that's commonly sold as Ozempic and Wegovy — and there's good reason.
But the Food and Drug Administration is now warning the public not to get carried away, issuing an alert that it's received reports of people getting hospitalized after overdosing on the drug, in some cases taking up to 20 times the recommended dosage.
Some of the reported adverse effects included nausea, vomiting, abdominal pain, fainting, migraines, and acute pancreatitis, according to the agency statement, released last week.
The majority of these cases are accidental, and stem from patients using a compounded form of the drug, which leads to errors in self-administering injections.
This typically isn't an issue when using brand name semaglutide. Both Ozempic and Wegovy are sold as pre-filled injection pens, and other forms of semaglutide, like Rybelsus, are taken orally as tablets — so a proper, safe dosage is already prepared for patients.
Compounded drugs, on the other hand, are made using raw ingredients by pharmacies — not a drug manufacturer — typically so that it can tailor the product to a patient's specific needs. This is a legal but not FDA-approved practice, and it's not the first we've heard of trouble when patients get semaglutide from compounding pharmacies.
In several reports, pharmacies miscalculated the correct concentration of the drug, "which resulted in patients administering five to 10 times more than the intended dose of semaglutide," the FDA said.
In most cases, however, patient error was to blame. Because the compounded drugs were sold in multi-dose vials, patients had to draw up the correct injection dose themselves.
"Unfamiliarity with withdrawing medication from a vial into a syringe and coupled with confusion between different units of measurement (e.g., milliliters, milligrams and 'units') may have contributed to dosing errors," the FDA said.
The FDA recommends that you avoid using a compounded drug if an approved form of it is available.
But because they're cheaper, compounded drugs remain an appealing option. There are currently no generic versions of semaglutide, while brands like Ozempic and Wegovy can cost over $1,000 per month without insurance.
Both drugs have been blockbuster hits, in large part due to their appetite-suppressing effects that help with losing weight. Due to differences in their dosages, only Wegovy is officially approved for weight loss, but Ozempic is sometimes prescribed by doctors for this purpose "off-label."
The hype that has already seen global demand skyrocket has been further fueled by early signs that semaglutide could help people stop smoking and cure a host of other ailments. Manufacturer Novo Nordisk said that Ozempic sales rose more than 40 percent on the year in the first quarter, while Wegovy's more than double.
But the Food and Drug Administration is now warning the public not to get carried away, issuing an alert that it's received reports of people getting hospitalized after overdosing on the drug, in some cases taking up to 20 times the recommended dosage.
Some of the reported adverse effects included nausea, vomiting, abdominal pain, fainting, migraines, and acute pancreatitis, according to the agency statement, released last week.
The majority of these cases are accidental, and stem from patients using a compounded form of the drug, which leads to errors in self-administering injections.
This typically isn't an issue when using brand name semaglutide. Both Ozempic and Wegovy are sold as pre-filled injection pens, and other forms of semaglutide, like Rybelsus, are taken orally as tablets — so a proper, safe dosage is already prepared for patients.
Compounded drugs, on the other hand, are made using raw ingredients by pharmacies — not a drug manufacturer — typically so that it can tailor the product to a patient's specific needs. This is a legal but not FDA-approved practice, and it's not the first we've heard of trouble when patients get semaglutide from compounding pharmacies.
In several reports, pharmacies miscalculated the correct concentration of the drug, "which resulted in patients administering five to 10 times more than the intended dose of semaglutide," the FDA said.
In most cases, however, patient error was to blame. Because the compounded drugs were sold in multi-dose vials, patients had to draw up the correct injection dose themselves.
"Unfamiliarity with withdrawing medication from a vial into a syringe and coupled with confusion between different units of measurement (e.g., milliliters, milligrams and 'units') may have contributed to dosing errors," the FDA said.
The FDA recommends that you avoid using a compounded drug if an approved form of it is available.
But because they're cheaper, compounded drugs remain an appealing option. There are currently no generic versions of semaglutide, while brands like Ozempic and Wegovy can cost over $1,000 per month without insurance.
Both drugs have been blockbuster hits, in large part due to their appetite-suppressing effects that help with losing weight. Due to differences in their dosages, only Wegovy is officially approved for weight loss, but Ozempic is sometimes prescribed by doctors for this purpose "off-label."
The hype that has already seen global demand skyrocket has been further fueled by early signs that semaglutide could help people stop smoking and cure a host of other ailments. Manufacturer Novo Nordisk said that Ozempic sales rose more than 40 percent on the year in the first quarter, while Wegovy's more than double.
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00:00People are excited to use semaglutide, a diabetes drug popular for assisting weight loss that's
00:06commonly sold as Ozempic and Wegavy, and there's good reason to be.
00:11Skip that.
00:12But the Food and Drug Administration is now warning the public not to get carried away,
00:17issuing an alert that it's received reports of people getting hospitalized after overdosing
00:22on the drug, in some cases taking up to 20 times the recommended dosage.
00:28Some of the reported adverse effects included nausea, vomiting, abdominal pain, fainting,
00:34migraines, and acute pancreatitis, according to the agency statement released last week.
00:41The majority of these cases are accidental and stem from patients using a compounded
00:46form of the drug, which leads to errors in self-administering injections.
00:51This typically isn't an issue when using brand name semaglutide.
00:55Both Ozempic and Wegavy are sold as pre-filled injection pens, and other forms of semaglutide,
01:02like Ribelsis, are taken orally as tablets, so a proper, safe dosage is already prepared
01:09for patients.
01:11Compounded drugs, on the other hand, are made using raw ingredients by pharmacies, not a
01:16drug manufacturer, typically so that it can tailor the product to a patient's specific
01:22needs.
01:23This is a legal but not FDA-approved practice, and it's not the first we've heard of
01:28trouble when patients get semaglutide from compounding pharmacies.
01:33In several reports, pharmacies miscalculated the correct concentration of the drug, which
01:38resulted in patients administering 5 to 10 times more than the intended dose of semaglutide,
01:45the FDA said.
01:47In most cases, however, patient error was to blame.
01:51Because the compounded drugs were sold in multi-dose vials, patients had to draw up
01:56the correct injection dose themselves.
01:59Unfamiliarity with withdrawing medication from a vial into a syringe and coupled with
02:04confusion between different units of measurement, e.g., milliliters, milligrams, and units,
02:11may have contributed to dosing errors, the FDA said.
02:14The FDA recommends that you avoid using a compounded drug if an approved form of it
02:20is available.
02:21But, because they're cheaper, compounded drugs remain an appealing option.
02:26There are currently no generic versions of semaglutide, while brands like Ozempic and
02:31Wegavi can cost over $1,000 per month without insurance.
02:36Both drugs have been blockbuster hits, in large part due to their appetite-suppressing
02:41effects that help with losing weight.
02:43Due to differences in their dosages, only Wegavi is officially approved for weight loss,
02:49but Ozempic is sometimes prescribed by doctors for this purpose, off-label.
02:54The hype that has already seen global demand skyrocket has been further fueled by early
02:59signs that semaglutide could help people stop smoking and cure a host of other ailments.
03:06Manufacturer Novo Nordisk said that Ozempic sales rose more than 40% on the year in the
03:12first quarter, while Wegavi's more than doubled.
03:15Needless to say, there's a lot of people trying to get their hands on semaglutide right
03:20now, so if you're one of the ones that does, please make sure you're taking it correctly.
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04:08By Tabula, FDA issues new warning as people overdose on weight loss injectables.
04:15The FDA said it had received multiple reports of dosing errors in which people mistakenly
04:21overdose on compounded semaglutide injectable products.
04:25By Kia Fatahi, 2319 Eastern Time, Monday, July 29th, 2024 updated, 1138 Eastern Time,
04:35Tuesday, July 30th, 2024.
04:38Bookmark.
04:39The FDA issued an alert warning that people are overdosing on weight loss drugs via self-injections.
04:46The FDA issued an alert warning that people are overdosing on weight loss drugs via self-injections.
04:53Image Getty.
04:54The U.S. Food and Drug Administration, FDA, has issued a new alert on Friday that some
05:00people are overdosing from certain medications that are marketed for weight loss.
05:05The FDA said it had received multiple reports of dosing errors in which people mistakenly
05:11overdose on compounded semaglutide injectable products by giving themselves 5 to 20 times
05:17more than the intended dose of the medication.