Australia’s drug regulator is investigating new reports of potential gastro-intestinal side effects of diabetes turned weight-loss drug Ozempic.
Ozempic, is a drug prescribed as a treatment for type 2 diabetes, but has been widely used off-label for weight loss, causing worldwide shortages, including in Australia. The same drug, branded as Wegovy, is now approved for weight management in Australia, but is not currently available.
There are already warnings about pancreatitis in the manufacturer’s product information about Ozempic, but Australia’s Therapeutic Good Administration (TGA) is considering whether updates to product information are required regarding intestinal obstructions, which health experts say are rare but predictable.
The TGA’s Database of Adverse Event Notifications has received three reports of intestinal obstructions and another report of “ileus paralytic,” which refers to bowel dysfunction.
A spokesperson for the TGA said it was important to note that “reporting of an adverse event … does not necessarily mean that a causal link with the medicine is established.”
“It may be a coincidence that the adverse event occurred when the medicine was administered or taken.”
Prof Gary Wittert, an endocrinologist from the University of Adelaide, said a sense of fullness and nausea are common side effects of Ozempic, as are vomiting, diarrhoea, and constipation. Rarer, but still predictable side effects, include gastrointestinal problems like pancreatitis, Wittert said.
A study published in the Journal of the American Medical Association last week found a 0.46% prevalence of pancreatitis in people taking Ozempic, and an even lower prevalence stopping gastric transit.
The TGA said it was aware of the article in the JAMA, as well as that the Food and Drug Administration (FDA) in the US recently added information about ileus in the product information for Ozempic.
Various side effects occur with all medications, so it becomes a question of benefit versus risk, Wittert said.
The benefit “skyrockets” for people with diabetes who have significant weight problems, are at risk of cardiac and renal disease, as well as potentially amputation, he said.
“For people with type 2 diabetes this has been life-changing medication … in general this is a pretty safe medication where the benefits are fantastic.”
“But but let’s be mindful that supply is limited, and it can have serious side effects, albeit rare, and they should be prescribed with due care and with consent from the patients who are receiving them so that they understand what the potential is however rare.”
Dr Ian Musgrave, a senior lecturer in pharmacology at the University of Adelaide, agreed gastrointestinal problems are not surprising because the class of drugs Ozempic is part of, known as glucagon-like peptide 1 (GLP-1) receptor agonists, are known to have a small risk of developing conditions like pancreatitis and gastroparesis, which is the slowing or stopping the movement of food from your stomach to your small intestine.
These gastrointestinal problems are related to the “mechanism of action” of the drug, as one of the ways that these drugs cause you to lose weight is by reducing gastric emptying, Musgrave said.
“The risk is not big, but for me the bigger issue is that because people are grabbing these things for weight loss, people who really need them for medical reasons are not getting them … so people who have a real medical need are not getting the access to these drugs.”
In the UK, shortages of these drugs for type 2 diabetics are expected to extend into 2024 and there are similar shortages here in Australia, Musgrave said.
