Watch the Digital Desk with Virginia Poison Center in the video player.
PORTSMOUTH, Va. (WAVY) – The U.S. Food and Drug Administration (FDA) is warning about overdosing on compounded semaglutide products.
The FDA released information saying there have been reports of dosing errors, some requiring medical attention and hospitalizations.
Dr. Rose from the Virginia Poison Center joined the Digital Desk to discuss the warning. Watch the livestream in the video player on this page.
You may have heard of semaglutide due to the popular medications Ozempic and Wegovy.
Currently, there are three FDA-approved semaglutide products: Ozempic injection, Rybelsus tablets, and Wegovy injection. According to the FDA, the medications are available only with a prescription and there are no approved generic versions. The medications are approved for type 2 diabetes and obesity, not for weight loss.
Compounded drugs are not FDA-approved. Compounded semaglutide is not reviewed for safety, effectiveness or quality, according to the FDA.
What do the drugs do?
“These are relatively new drugs intended to treat diabetes,” said Rose. “They enhance insulin release and they may actually decrease another hormone called glucagon. And, as these drugs gain some experience it was discovered that they actually have some effects in the brain, one of which was to decrease appetite.”
Rose said we’re seeing these injectables be used for weight control and appetite suppression.
“These are injectable drugs intended to be given once a week and whenever that type of administration happens there is always some room for human error in making sure you get the right dose,” said Rose.
The FDA said the majority of reports said patients had incorrectly measured their dose for the intended compounded semaglutide. Some patients had administered five to twenty times the prescribed dosage. In the press release, they write most patients were unfamiliar with measuring the correct amount by using a syringe.
It is not only patients measuring incorrect dosage, but the FDA released reports that health care providers have incorrectly calculated the intended dose for patients.
“It’s critically important to take medication as prescribed and it’s also very important for over-the-counter (OTC) medications,” said Rose. “Exceeding the recommended dose can be even very harmful for them.”
Rose stresses the need for communication with doctors and pharmacists to understand the medication, the dosage and application, in verbal and written instructions.
As the market utilizes the drugs, Rose said people are turning toward the internet and compounding pharmacies, which may or may not be legitimate.
The FDA warns of illegally marketed semaglutide online and is investigating reports of counterfeit Ozempic in the country.
The FDA has also previously alerted consumers to not buy off-brand versions of Ozempic and Wegovy.
“I think the risk for these particular products are two-fold,” said Rose.
First, what is in the products, if you buy one off the internet for example. Rose said most of the products have the active ingredient semaglutide in it, but they may differ than what’s on the label.
“They may have different concentrations by 20 to 25 to 30 to 40%,” said Rose. “It might also have contaminants, depending on where the product is made.”
Second, unlike the pre-filled prescription medications, the compounded injectables have to be measured.
“If you buy these over the internet, there’s a good chance you’re going to get a vial of the medication and some syringes, and you have to draw it up yourself,” said Rose.
The instructions may differ, and it could cause confusion. Some may use different units, like milliliters or milligrams.
“That is where we’re seeing those dosing errors occur,” said Rose.
When you’re purchasing compounded medication you have to be careful where it is coming from, and what is in it.
“It’s a little bit of buyer beware, so you may not really get what you think you’re getting,” said Rose. “It may be a different concentration or strength and it may be very difficult to dose accurately.”
Rose said providers and pharmacists need that communication, to counsel patients about the risks of doing that.
“Not every case has a bad outcome, for sure, but the risk of a bad outcome just becomes much higher as you introduce all these potential problems with not only the product but also administering the product,” said Rose.
The FDA said the wrong dosing of the self-injectable compounded semaglutide has led to some patients experiencing gastrointestinal issues, including nausea, vomiting and abdominal painting. Others have reported fainting, headache, migraine, dehydration, acute pancreatitis and gallstones.
Since 2016, the Virginia Poison Center has had 178 reports of these types of cases for semaglutide products. Rose said the cases are exponentially increasing, with 53 so far this year at his center that provides coverage for eastern Virginia.
“Most of these seem to be the commercial products that are legitimate, and most of these are unintentional,” said Rose.
Rose said any time you have a question about a medication, you can contact the Virginia Poison Center.
For emergency assistance, call the Virginia Poison Center 24/7 at the local number at (804) 828-9123 or toll-free at (800) 222-1222. If someone is unconscious, seizing or unable to breathe, dial 911 right away.
Watch the full Digital Desk segment to hear more about the warning.