US health officials are once again updating the warning label on the diabetes weight-loss drug Ozempic, now adding that it can cause a potentially fatal 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 mentioned side effects of nausea, vomiting, diarrhea and constipation.
Doctors say that while ileus is rare, in severe cases it can lead to perforation – or a tear – in the intestine, which puts stomach fluids at risk of 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 a lack of movement in the intestines, causing a blockage (stock image from Ozempic)
The FDA announced last week that it had requested a label update for semaglutide – the drug in Ozempic – to include the side effect.
However, labels for the similar drug Wegovy – which also uses semaglutide – do not need to change because they already mention the condition.
The FDA said it could not say how common the side effect is because only a few reports have been received.
Data showed the agency has received 33 reports of the condition out of 19,000 adverse events it has recorded – or 0.2 percent of all cases.
Other reports include paralytic ileus, where normal bowel movements are prevented, and gastric ileus, when the condition affects the stomach.
This update comes after DailyMail.com reported in March on research warning that Ozempic could cause the small intestine to become enlarged, risking an obstruction.
Doctors say the drug may cause the condition because it works by slowing the movement of food through the intestines, making a person feel full longer.
A spokeswoman for Novo Nordisk, maker of Ozempic, said the drug is still safe and effective to use.
She said: ‘Novo Nordisk stands behind the safety and efficacy of Ozempic and all our medicines when used in accordance with the product labeling and approved indications.
‘For Ozempic, the most commonly reported side effects are: nausea, vomiting, diarrhea, stomach pain (abdominal pain) and constipation.’
During the normal digestion process, the intestines continually contract – known medically as peristalsis – to move food through the body.
But with ileus, these contractions are interrupted or delayed, slowing the movement of food through the intestine and increasing the risk of blockage.
Symptoms of ileus include abdominal swelling, bloating, constipation, diarrhea, vomiting, and an inability to pass gas.
Ozempic and Wegovy work by causing the body to produce a hormone called glucagon-like peptide-1, which is released naturally from the intestines after meals.
Patients who are concerned that they may have the condition should seek immediate medical attention, which often includes hospitalization to receive treatment.
In cases where the blockage is partial, patients can be switched to a low-fiber diet until the body clears the food on its own.
But with a complete obstruction, where nothing can get through, patients will need surgery to relieve the blockage.
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 portion may be removed.
Treatment may also include discontinuing medications such as Ozempic.
The condition can become fatal if it leads to perforation of the intestine.
Nearly 500,000 Americans are hospitalized with ileus each year, data shows.