Singulair Churg Strauss Syndrome, Leukotriene Receptor Antagonists, Syndrome Characterised, Systemic Vasculitis, Asthma Drugs

From a UK Yellow Card Report.

Montelukast

The product information for montelukast has been amended to include the following ADRs: Reaction No. of UK Yellow Card reports

Nausea 63 Diarrhoea 54 Rashes 52 Insomnia 44 Dizziness 42 Fatigue 37 Vomiting 24 Pruritus 24 Arthralgia 20 Urticaria 19 Malaise 18 Dyspepsia 13 Myalgia 12 Dry mouth 9 Anaphylaxis 4 Angioedema3

In addition, the following suspected ADRs have been reported and are still being evaluated: psychiatric disorders (63) [including aggression (7), abnormal behaviour (4), agitation (3), mood alteration (3), anxiety (3) and hallucinations (3)]; also nightmares (13), sedation (13), palpitations (12), tremor (10) and increased sweating (10).
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Zafirlukast The most frequently reported ADRs under the Yellow Card Scheme for zafirlukast have been rashes (7), headache (7), abdominal pain (6), nausea (6) and pruritus (5). All of these are included in the product information which has also been updated to include the following ADRs that have been identified from data other than UK Yellow Card reports: urticaria, angioedema, blistering, bruising, bleeding disorders, including menorrhagia (rare), thrombocytopenia and agranulocytosis (both very rare). Churg-Strauss syndrome Churg-Strauss syndrome (CSS) is a rare syndrome characterised by a history of asthma, and often rhinitis and sinusitis, with systemic vasculitis and eosinophilia. There has been a recent increase in the number of reports of CSS associated with the use of anti-asthma drugs, particularly the leukotriene receptor antagonists. The MHRA/CSM have received 63 reports of CSS through the Yellow Card Scheme since 1963, 59 since the beginning of 1998; Of these, 90% were associated with drugs used to treat asthma (mainly leukotriene receptor antagonists). In many, but not all cases there was documented evidence of a reduction or withdrawal of oral corticosteroid therapy prior to the onset of the reaction. There are clear warnings regarding the possible association with CSS in the product information for montelukast and zafirlukast. Prescribers should be aware of the possibility that, although rare, CSS may be the underlying cause of asthma in their patients. In patients prescribed a leukotriene receptor antagonist prescribers should be alert to the development of eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications and/or peripheral neuropathy. The identification of new and suspected ADRs emphasises the important role of the Yellow Card Scheme in helping to ensure the safe use of medicines. The safety profile of leukotriene receptor antagonists remains under close review. Please continue to report all suspected ADRs to montelukast (Singulairt) and zafirlukast (Accolatet) through the Yellow Card Scheme.1. MHRA/CSM Current Problems in Pharmacovigilance 1998; 24:14.
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