The TGA will include warnings of intestinal obstruction, including ileus, in the product information of all GLP-1 agonists. Suicidal ideation will also be added for Mounjaro.
The TGA has said it will add intestinal obstruction, including ileus, to the product information of all GLP-1 receptor agonists available in Australia, following the lead of the FDA in the US.
In October last year, the TGA announced that it was investigating the gastrointestinal side effects of popularised GLP-1 receptor agonist Ozempic, after the FDA opted to update the drug’s product information to include warnings of intestinal dysfunction.
Other GLP-1 RAs Mounjaro and Wegovy already contained warnings regarding the ileus in the US.
New Zealand’s Medicines Adverse Reactions Committee also recommended that the data sheets for all GLP-1 RAs be updated to list gastrointestinal obstruction as a class adverse event in its September meeting last year.
On Tuesday, the TGA released safety related updates to the product information including for GLP-1 receptor agonists Ozempic, Mounjaro and Trulicity.
A TGA spokesperson told pharma in focus that the PIs for all GLP-1 RA would be updated to include the potential risk of intestinal obstruction, including the ileus.
“The assessment concluded that there are sufficient safety grounds to update the PI for all GLP-1 RA products to inform health professionals regarding the potential risk of intestinal obstruction, including the ileus,” they said.
Beyond Ozempic, GLP-1 RA products in Australia include Novo Nordisk’s other semaglutide drugs Wegovy and Rybelsus and liraglutide-containing drugs Saxenda, Vicoza and Xultophy.
Eli Lilly’s Trulicity and Mounjaro have also been affected.
Despite the European Medicine Agency clearing GLP-1 agonist of links to suicidal ideation in April, Eli Lilly requested that the PI for Mounjaro include “suicidal ideation and behaviour (class effect – not particular to this product)”, according to pharma in focus.
The administration has updated Mounjaro’s PI to also include special warnings of suicidal ideation and behaviour, as well as include severe gastrointestinal disease for gastroparesis and malnutrition.
The TGA told pharma in focus that its investigation into the GLP-1 RAs and suicidal ideation was ongoing.
Special warnings of gastroparesis and pulmonary aspiration and elevation of liver enzymes (adverse event) were also updated in Trulicity’s PI.
Ozempic’s PI also included updates to its interaction with warfarin to include other coumarin derivatives.
