U.S. health officials are once again updating the warning label for the diabetes-turned weight-loss drug Ozempic, now adding that it can cause a life-threatening intestinal blockage.
The Food and Drug Administration (FDA) says the drug can cause a condition called ileus, or intestinal obstruction, when parts or all of the intestines become blocked. This can cause blood flow to the organs to be cut off, leading to tissue death.
This complication will be added to the already listed side effects of nausea, vomiting, diarrhea, and constipation.
Doctors say that, although rare, in severe cases ileus can cause a perforation (or tear) in the intestine, with the risk of gastric juices leaking into the body. Health experts suggest the condition has a mortality rate of up to one in ten.
The Food and Drug Administration says Ozempic can cause ileus, a medical term for lack of movement in the intestines, with a risk of obstruction (Ozempic file image)
The FDA revealed that it was requesting to update the label for semaglutide, the drug in Ozempic, to include the side effect last week.
However, the labels for the similar drug Wegovy, which also uses semaglutide, will not need to be changed because they already mention the condition.
The FDA said it could not say how common the side effect is because it has only received a few reports.
The data showed that the agency has received 33 reports of the condition out of the 19,000 adverse reactions it has recorded, or 0.2 percent of all cases.
Other reports include paralytic ileus, where normal bowel movement is impaired, and gastric ileus, where the condition affects the stomach.
This update comes after DailyMail.com reported on research in March that warned that Ozempic could cause the small intestine to enlarge, risking obstruction.
Doctors say the medication may cause the condition because it works by slowing the movement of food through the intestines, helping the person feel fuller longer.
A spokeswoman for Novo Nordisk, which makes Ozempic, said the drug was still safe and effective to use.
She said: ‘Novo Nordisk stands behind the safety and effectiveness of Ozempic and all our medicines when used in accordance with product labeling and approved indications.
“For Ozempic, the most commonly reported side effects include: nausea, vomiting, diarrhea, stomach (abdominal) pain, and constipation.”
In the normal digestion process, the intestines continually contract (medically known as peristalsis) to move food through the body.
But in ileus, these contractions are interrupted or slowed, delaying the movement of food through the intestine and increasing the risk of an obstruction.
Symptoms of ileus include abdominal bloating, bloating, constipation, diarrhea, vomiting, and inability to pass gas.
Ozempic and Wegovy work by causing the body to produce a hormone called glucagon-like peptide 1 that is released naturally from the intestines after meals.
Patients who fear they have this condition should seek immediate medical attention, which often includes a stay in the hospital for treatment.
In cases where the blockage is partial, patients can be switched to a low-fiber diet until the body eliminates the food on its own.
But in case of complete obstruction, where nothing can get through, patients will need surgery to relieve the obstruction.
To do this, an incision is made in the abdominal wall before doctors attempt to remove the obstruction. In cases where the intestine is severely damaged or diseased, the affected section may be removed.
Treatment may also involve stopping medications such as Ozempic.
The condition can become fatal when it leads to perforation of the intestine.
Nearly 500,000 Americans are hospitalized with ileus each year, data suggest.