The MHRA have issued a reminder to healthcare professional on the possible neuropsychiatric reactions that may occur with montelukast. It has been known for some time that these neuropsychiatric reactions may occur in association with montelukast treatment, and these reactions are listed as possible side effects in the product information

A range of neuropsychiatric reactions has been reported in association with montelukast. Among these are: sleep disturbances, depression and agitation (may affect up to 1 in 100 people taking montelukast); disturbances of attention or memory (up to 1 in 1,000 people); and very rarely, hallucinations and suicidal behaviour (up to 1 in 10,000 people). The product information is also being updated to include stuttering and obsessive-compulsive symptoms as very rare (thought to affect fewer than 1 in 10,000 patients) potential neuropsychiatric adverse events with montelukast.

A recent EU review confirmed the known risks of neuropsychiatric reactions 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. Therefore, the MHRA are reminding healthcare professionals of the possible risks and the need to consider the benefits and risks of continuing treatment if they occur.

For full information please see https://www.gov.uk/drug-safety-update/montelukast-singulair-reminder-of-the-risk-of-neuropsychiatric-reactions and the Summary of Product Characteristics for montelukast.

Contact your ward pharmacist or Speeds Healthcare Team on 0843 506 55 66 for further information