Novo Nordisk's Wegovy and Ozempic, popular medications for obesity and diabetes respectively, used by millions of people worldwide, are being scrutinized for new serious side effects.
This was reported by the Danish media outlet B.T.
Wegovy is a recently introduced drug primarily used to treat obesity. The active ingredient in Wegovy is semaglutide, which is also used in the treatment of type 2 diabetes. Wegovy works by mimicking a hormone that regulates appetite and food intake, resulting in weight loss. It is administered weekly via an injection.
Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are now investigating these drugs for potentially serious side effects such as hair loss, suicidal thoughts, and aspiration – a condition where food and drink are inhaled into the lungs, which can be life-threatening.
The FDA has also added a warning
Line Michan, head of the Danish Medicines Agency's drug monitoring unit, confirms that they are aware of the three symptoms reported by the FDA. The EMA has already identified suicidal thoughts as a possible side effect, and hair loss is listed on the European package inserts.
Michan further explains that aspiration can theoretically be caused by the drug slowing down intestinal emptying, increasing the risk of reflux. The FDA has also added a warning about intestinal obstruction or blockage as another new side effect on the package inserts for these medications, which can ultimately be life-threatening.
Novo Nordisk has responded to these investigations by emphasizing the safety of their products. In a written response to B.T., they say:
"Novo Nordisk works closely with authorities, both the FDA and EMA, to ensure patient safety. Safety data collected from large clinical trial programs and post-marketing surveillance have not shown a causal relationship between semaglutide or liraglutide and suicidal thoughts and self-harm. A large study, published in the scientific journal Nature last week, showed the same."
Karsten Juhl Jørgensen, professor and senior physician at Cochrane Denmark, points out that it is common to discover unknown side effects after approval. He explains that the trials are primarily designed to demonstrate the drug's beneficial effect, which can mean that rare side effects are overlooked. "You also only discover the side effects you look for," he concludes.