The TGA may consider updating the product information to include a health warning about the stomach disorder ileus, after investigating reports of intestinal obstruction in patients using the anti-diabetic and weight loss medicine, semaglutide (Ozempic). The watchdog organisation said it had received four reports of adverse gastrointestinal events linked with semaglutide to date, AusDoc has reported. These included two cases of intestinal obstruction and one case each of small intestinal obstruction and ileus paralytic. However, the TGA stated that the notifications did not necessarily mean a causal link with the medicine had been established. A new study in the US has also suggested that people taking weight loss medicines, including Wegovy, Ozempic, Saxenda and Victoza, may be at higher risk for serious digestive problems such as stomach paralysis, pancreatitis, and bowel obstructions, compared with those taking other types of weight reduction medications, CNN has reported recently. The study published last week in JAMA, HERE, found risks of these events happening to individual patients appears to be rare – about 1% of people taking Ozempic were diagnosed with stomach paralysis. But demand for the drugs has exploded, with tens of millions now taking them worldwide. Researchers say even rare risks like these may amount to hundreds of thousands of new cases. “When you have millions of people using these drugs, you know, a 1% risk still translates to many people who may experience these events,” said lead study author Dr Mahyar Etminan, an epidemiologist at the University of British Columbia. In the group of roughly 600 patients who were taking Ozempic, there were four cases of gastroparesis or stomach paralysis, two cases of pancreatitis, no bowel obstructions, and five who developed biliary disease. In the 4,400 people taking Saxenda, there were 66 cases of stomach paralysis, 73 bowel obstructions, 71 cases of pancreatitis, and 162 cases of biliary disease. Of about 650 people taking Contrave, by contrast, there were three cases of stomach paralysis, two bowel obstructions, one case of pancreatitis, and 16 cases of biliary disease. The study has limits as it is observational, so it can only show associations. It can’t prove the drugs caused the conditions people were diagnosed with, said the researchers. Novo Nordisk, the manufacturer of both Ozempic and Saxenda, said it stands behind the safety and efficacy of all its GLP-1 medications when used consistent with the product labelling and approved indications. “With respect to the study, as the authors acknowledge, the study has limitations, including potential confounding by indication and by other factors,” the company said in a statement to CNN. “We recommend patients take these medications for their approved indications and under the supervision of a healthcare professional.” JG