MHRA calls for more prominent warnings neuropsychiatric reactions with montelukast

30 April 2024

More prominent warnings are to be added to the package insert of montelukast (Singulair) in the UK, reminding patients and healthcare professionals that they should be alert to serious behavior and mood-related changes (neuropsychiatric reactions) associated with the treatment, said the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

Singulair is an asthma med developed by Merck & Co (NYSE: MRK) and now an Organon (NYSE: OGN) product.

The US Food and Drug Administration added a black box safety warning to the Singulair label in 2020, strengthening existing advice about the risk of neuropsychiatric events associated with the drug, generic versions of which are now also widely available.

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