Home » Drug Information » FDA Approved Drugs » 1998
Medical Areas: Pediatrics/Neonatology | Pulmonary/Respiratory Diseases | Family Medicine
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved February 1998
Treatment Area: asthma
Of the new class of asthma medicines called leukotriene
blockers, Singulair is the first intended for both adults and
children as young as six, and the first developed for once-daily
use. Singulair works by blocking leukotrienes, powerful substances
that are involved in the inflammatory process associated with
Singulair has been studied for the long-term control of asthma,
but is not intended for the relief of acute asthma episodes or
symptoms. It should not be used to relieve an asthma episode or be
abruptly substituted for oral or inhaled corticosteroids. Patients
should have quick-relief medicines available to treat worsening
The marketing clearance of Singulair is based on clinical
studies that measured efficacy and safety in more than 3,000 adults
and children, aged six to 14 years.
In clinical studies, Singulair improved asthma control in many
patients by significantly decreasing asthma attacks, preventing
daytime and night-time asthma symptoms, and reducing reliance on
other asthma medicines, such as quick-relieving bronchodilators. It
also allowed many patients to reduce gradually their use of inhaled
steroids. Inhaled steroids are the most commonly used drugs for
long-term asthma control, but they can be difficult to use and have
been associated with potential side effects, particularly at high
doses and with long-term use. However, Singulair may not completely
eliminate the need for inhaled or systemic corticosteroids.
Patients should not decrease or stop taking other asthma medicines
unless instructed by their doctor.
Side effects with Singulair were usually mild and generally did
not require patients to stop taking Singulair. Side effects seen in
adults and children during the clinical trials were similar for the
groups treated with Singulair and for those treated with placebo.
The most commonly reported side effects in adults for both placebo
and Singulair were headache, influenza and abdominal pain. There
was no increase in side effects with extended treatment, and no
clinically meaningful drug interactions.