Montelukast: UK regulator says asthma drug needs clearer warnings of side effects

The asthma drug montelukast (Singulair) will carry more prominent warnings in the UK to alert doctors and patients to its potentially serious behavioural and neuropsychiatric side effects.Previously noted side effects associated with the oral treatment include sleep disturbances, depression, and agitation (which may affect up to one in 100 people); disturbances of attention or memory (up to one in 1000); and hallucinations and suicidal behaviour (up to one in 10 000).After reviewing the risks associated with the drug and awareness of the side effects1 the UK Medicines and Healthcare Products Regulatory Agency (MHRA) published the new advice. It said that while the risks remain unchanged, reports have indicated that side effects are potentially not well known by clinicians and patients, and that clearer warnings are needed.Latest data from the Yellow Card scheme show that MHRA received 1282 reports of suspected neuropsychiatric adverse drug reactions to montelukast between 1998 and the…
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