All patients and doctors should receive the same warnings about montelukast’s side effects. But US patients and doctors get far stronger warnings than Australians.

In 2020, the US FDA also issued a Medication Guide (MG) [which must be provided to patients when dispensed]. MGs are issued when the FDA determines: “The drug has serious risk(s) (relative to benefits) of which patients should be made aware because information concerning the risk(s) could affect patients’ decision to use, or to continue to use, the product.” 

Boxed warning, top first page for US doctors

Detailed information on page 5 for US doctors

Warning of some effects, middle page 3 for Australian doctors

Some extra effects listed on page 8 for Australian doctors

Warning, top first page for US patients

Warning middle page 3 for Australian patients

Why different warnings for the same drug?


Sign and share the petition to insist Australian consumers are adequately warned about the potential mental health side effects of this drug.