Safety Update – Montelukast (Singulair)

Drug Safety Communication

Montelukast (Singulair) – Risk of Neuropsychiatric Reactions

MHRA has issued a new drug safety updatereminder whereHCPsshould be alert for neuropsychiatric reactions in patients taking Montelukast and carefully consider the benefits and risks of continuing treatment if they occur.It has been known for some time that neuropsychiatric reactions may occur in association with Montelukast treatment, and these reactions are listed as possible side effects in the product information. A recent EU review confirmed the known risks of neuropsychiatricreactions and found that the magnitude of risk was unchanged. However, the review identified some cases in which there had been a delay in neuropsychiatric reactions being recognised as a possible adverse drug reaction.

Advice for healthcare professionals:
  • Be alert for neuropsychiatric reactions in patients taking Montelukast; events have been reported in adults, adolescents, and children.
  • Advise patients and their caregivers to read carefully the list of neuropsychiatric reactions in the patient information leaflet and seek medical advice immediately should they occur.
  • Evaluate carefully the risks and benefits of continuing treatment if neuropsychiatric reactions occur.
  • Be aware of newly recognised neuropsychiatric reactionsof speech impairment (stuttering) and obsessive–compulsive symptoms.
Advice to give to patients and caregivers:
  • It is important you or your child do not stop Montelukast without talking to a doctor or asthma nurse first.
  • Adverse reactions affecting sleep, behaviour, and mood have been infrequently reported in people taking Montelukast.
  • Always read the leaflet that accompanies your or your child’s medicines, and talk to a healthcare professional if you suspect any serious reactions to Montelukast.