Here's What Two Doctors Say About The New FDA Warning For Ozempic
The buzzy injectable drug for type 2 diabetics, Ozempic, has become a household name in 2023 thanks to reports that the medication can be prescribed off-label and used for significant weight loss.
Last month, the FDA warned users of a possible serious side effect to look out for: Intestinal blockage.
Ozempic is the brand name for semaglutide, a medication that helps people with type 2 diabetes manage blood sugar levels by mimicking a protein called glucagon-like peptide 1 (GLP-1), explains Mir Ali, M.D., a bariatric surgeon and medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, Calif.
Ozempic can also help decrease your hunger cues and slow digestion in your gut, Dr. Ali says—which can lead to weight loss.
Meet the experts: Mir Ali, M.D., is a bariatric surgeon and medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, Calif. Suneal Agarwal, M.D., is an associate professor of Gastroenterology at Baylor College of Medicine.
But as with many medications, Ozempic can result in other side effects. And since hitting the market, at least 16 people have reported serious intestinal blockages linked to Ozempic so far. In response, the FDA updated the Ozempic label with a warning about this potential side effect on Sept. 22, so it’s understandable to have some questions.
Here's the deal with the new Ozempic warning label, plus what it actually means, according to experts.
How does Ozempic work?
Semaglutide, the active ingredient in Ozempic mimics the naturally occurring GLP-1 protein in your body. It binds to GLP-1 receptors in your digestive tract, telling your body to release insulin, a hormone that helps your body use and store sugar for energy.
Ozempic can also help decrease your hunger cues and slow digestion in your gut, Dr. Ali says—which can lead to weight loss.
While it's technically approved to treat type 2 diabetes, a smaller-dose semaglutide medication, Wegovy, is approved by the Food and Drug Administration (FDA) for weight loss, so Ozempic has been prescribed off-label for weight loss.
What are Ozempic’s side effects?
Ozempic says on its website that these are the most common side effects users experience:
Nausea
Diarrhea
Stomach pain
Vomiting
Dr. Ali says nausea is common, and says it's probably the top reported side effect.
What is the new FDA warning for Ozempic?
The new warning is pretty technical, but it notes that ileus—the medical term for an intestinal blockage—has been linked to Ozempic use. The FDA did not comment on the new side effect beyond adding "Gastrointestinal Disorders: Ileus" to the "adverse reactions" section.
But the warning also adds that “because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.”
Basically, the FDA is saying that, while intestinal blockages have been linked to Ozempic use, there’s nothing right now that definitively says that Ozempic caused the blockages.
What is intestinal blockage?
An intestinal blockage is essentially when food and waste can’t get through your gut, and instead gets stuck in your intestines.
“Things aren't passing through,” Dr. Ali says. “It’s either mechanical, which is a twist or kink or, less commonly, an ileus, which is when the intestine is not functioning properly and pushing things through.”
How serious is intestinal blockage?
An intestinal blockage is definitely serious and can be fatal. The U.S. National Library of Medicine points out that this type of gastric issue can lead to a slew of potential complications, including:
Electrolyte imbalances
Dehydration
A hole in the intestine
Infection
Jaundice (which is yellowing of the eyes and skin)
If the blockage blocks off blood supply to the intestine, it can lead to infection and tissue death, the U.S. National Library of Medicine says—meaning, part of your intestines die and no longer work.
"An intestinal blockage is extremely serious and requires emergency evaluation and possible surgery," says Suneal Agarwal, M.D., an associate professor of Gastroenterology at Baylor College of Medicine.
How long can you go with an intestinal blockage?
Not long. You need to seek medical treatment pretty quickly if you think you might have an intestinal blockage. Dr. Ali says a blockage is a "surgical emergency."
“Typically, we want to address that within 24 hours," he says.
Depending on the situation, doctors may monitor a patient in the hospital for a brief period of time to see if the blockage improves on its own, or they’ll do surgery, he says.
How do I prevent intestinal blockage?
Intestinal blockages can’t necessarily be prevented. “Usually it’s something that just happens, like a side effect of a medication,” Dr. Ali says. “Typically if the patient stops the medication, it improves.”
In the U.S., the most common cause of intestinal blockage is having a previous surgery in the abdominal cavity that causes scar tissue, Dr. Ali says—and that’s not really something you can help, either.
Severe constipation can lead to an intestinal blockage, too—in that case, doctors may use laxatives or enemas to try to move things along, Dr. Ali says.
Why did the FDA add this label?
The FDA added the warning to make people aware that intestinal blockages could potentially occur while taking Ozempic, Dr. Ali says.
Worth noting: Warning labels on Wegovy and Mounjaro, another diabetes medication that can result in weight loss, already warn that ileus could be a potential side effect.
Is it still safe to take Ozempic?
Short answer, yes. "It is generally considered safe, as the rates of complications are low," Dr. Agarwal says.
Also important to note: Current data hasn’t *proven* Ozempic causes intestinal blockages, but rather establishes a link between usage and blockage. And both Wegovy and Mounjaro already warn that intestinal blockage is possible.
Overall, Dr. Ali says that people struggling with weight loss and obesity tend to benefit from Ozempic. “It’s still considered safe,” he says. “These more severe complications are still fairly rare.”
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