UK MHRA reiterates montelukast safety warning
A drug safety update from the UK Medicines and Healthcare products Regulatory Agency (MHRA) reminds prescribers of the potential risk of neuropsychiatric adverse events in patients receiving montelukast, including:
sleep disorders,
hallucinations,
anxiety and depression, and
changes in behaviour and mood.
Summary
Definition
History and exam
Key diagnostic factors
- presence of risk factors
- expiratory wheezes
- dyspnoea
- cough
- chest tightness
- diurnal variability of symptoms
- episodic symptoms
- historical record of variable peak expiratory flow (PEF) or FEV₁
- nasal polyposis
- recent upper respiratory tract infection
Risk factors
- family history
- allergens/irritants
- atopic disease history
- cigarette smoking
- vaping
- respiratory viral infection early in life
- nasal polyposis
- low socioeconomic status
- obesity
- gastro-oesophageal reflux
- obstructive sleep apnoea
Diagnostic investigations
1st investigations to order
- spirometry (FEV₁/FVC ratio and BDR)
- peak expiratory flow (PEF)
Investigations to consider
- CXR
- FBC with differential
- fractional exhaled nitric oxide (FeNO)
- bronchial challenge test
- allergen testing
Emerging tests
- sputum eosinophilia
Treatment algorithm
infrequent symptoms
step 1: initial therapy (not controlled by SABA as needed)
step 2: initial add-on therapy (asthma not controlled with low-dose ICS and SABA as needed)
step 3: additional controller therapies (asthma not controlled with step 2)
step 4: specialist therapies (asthma not controlled with step 3)
Contributors
Authors
Onyeka Umerah,
Consultant Respiratory Physician
Glenfield Hospital
Leicester
UK
Disclosures
OU declares that she has no competing interests.
Acknowledgements
Dr Onyeka Umerah would like to gratefully acknowledge Dr Lauren E. Eggert, Dr Sourav Majumdar, Dr Irwani Ibrahim, Dr Kay Choong See, Dr Francis Thien, and Dr Catherine Weiler, previous contributors to this topic.
Disclosures
LEE declares that she has conducted sponsored research with Regeneron Pharmaceuticals. SM, II, KCS, FT, and CW declare that they have no competing interests.
Peer reviewers
F. Runa Ali,
Consultant Allergist & Respiratory Physician
Barts Health NHS Trust
London
UK
Disclosures
FRA declares that she has no competing interests.
Laia Castro Salvador,
Severe Asthma & Allergy Specialist Clinical Pharmacist
Barts Health NHS Trust
London
UK
Disclosures
LCS declares that she has no competing interests.
Differentials
- COPD
- Chronic rhinosinusitis
- Breathing pattern disorder
More DifferentialsGuidelines
- Asthma: diagnosis, monitoring and chronic asthma management
- British guideline on the management of asthma
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