Tolerability of Montelukast

The tolerability of a medication, especially in children with asthma, is linked to a number of key factors. These include clinical effectiveness, adverse effects,
frequency of drug regimen, ease and route of administration, and taste. Montelukast is unusual in that, in most countries, a licence for children aged ≥6 years was granted at the same time as the adult licence. This is related to a
variety of evidence, which includes pharmacological and adult studies suggesting the specificity and safety of the drug at many times the licensed dose, and a tolerability profile similar to that with placebo or inhaled corticosteroids in both adult and paediatric studies. The most common adverse effects in paediatric studies were headache, asthma and upper respiratory tract infection at rates not statistically significantly different from those with placebo.
Up to July 1999, more than 2 million patients worldwide have received montelukast, of whom nearly 220 000 have received the paediatric formulation. In the UK, one prescribing database suggests that, of children who commenced
montelukast therapy, less than 25% discontinued the drug. This implies that montelukast is effective and well tolerated in most children.
Adverse effect monitoring by regulatory bodies has revealed little that would not be expected on the basis of the results of clinical trials. Montelukast has been associated with Churg-Strauss syndrome in a very small number of adults. In most, the syndrome was associated with corticosteroid withdrawal, which may have unmasked the condition. Churg-Strauss syndrome has not been reported in children. Its clinical effectiveness, lack of major adverse effects, oral route of administration, palatability and the once-daily regimen combine to make montelukast a generally well tolerated medication in children.