Australia’s Therapeutic Goods Administration (TGA) recently issued a safety alert requiring extra warnings to be included with the asthma and hay fever drug montelukast.
The warnings are for users and their families to look for signs of serious behaviour and mood-related changes, such as suicidal thoughts and depression. The new warnings need to be printed at the start of information leaflets given to both patients and health-care providers (sometimes called a “boxed” warning).
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