FDA forces Ozempic to list new DEADLY side effect on drug label

US Health officials are once again updating the warning label on the diabetes-turned weight-loss drug Ozempic, now adding it can cause a potentially deadly intestinal blockage. 

The Food and Drug Administration (FDA) says the medication can cause a condition called ileus — or a bowel obstruction, when parts or all of the intestines become blocked. This can cause blood flow being cut off to the organs, which leads to tissue death.

This complication will be added to the already listed side effects of nausea, vomiting, diarrhea and constipation.

Doctors say, although rare, in serious cases ileus can lead to perforation — or a tear — in the bowel, risking gastric juices to leak into the body. Health experts suggest the condition has a fatality 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, risking a blockage (stock image of Ozempic)

The FDA revealed it was requesting the label update for semaglutide — the drug in Ozempic — to include the side effect last week.

Labels for the similar drug, Wegovy — which also uses semaglutide — will not need to change, however, because they already mention the condition.

The FDA said it was unable to say how common the side effect is because it has only received a few reports.

Data showed 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, when the condition affects the stomach.

This update comes after DailyMail.com reported on research in March that warned 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 bowels, helping someone feel full for 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 efficacy of Ozempic and all of our medicines when used consistent with the product labeling and the 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 bowel and raising the risk of a blockage.

Symptoms of ileus include abdominal swelling, bloating, constipation, diarrhea, vomiting and an inability to pass gas.

Ozempic and Wegovy work by triggering the body to produce a hormone called glucagon-like peptide-1 that is released naturally from the intestines after meals

Patients who fear they may have the condition should seek immediate medical care, which often includes a hospital stay to receive treatment.

In cases where the blockage is partial, patients may be switched to a low-fiber diet until the body passes the food on its own.

But in complete obstruction, where nothing is able to pass through, patients will require surgery to relieve the blockage.

For 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 discontinuing medications like Ozempic.

The condition can become fatal when it leads to perforation of the bowel.  

Nearly 500,000 Americans are hospitalized with ileus every year, data suggests.