In the April 2013 edition of the Medicines Safety Update, the Therapeutic Goods Administration (TGA) of Australia reminded the public of potential neuropsychiatric adverse events associated with Singulair (montelukast) treatment. Neuropsychiatric events include suicidal ideation, depression, agitation, aggressive behavior, hallucinations, insomnia, and tremor, as well as other side effects.
Singulair (or generic montelukast) is indicated for prevention and chronic treatment of asthma in patients 12 months of age and older. It is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older, and for relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 6 months of age and older. Manufactured by Merck, Singulair was first FDA approved on February 20, 1998.
The “Warnings and Precautions” section prescribing information for Singulair and generic montelukast include a general warning for the possibility of experiencing such side effects in children, adolescents, and adults. TGA received 58 reports of neuropsychiatric events in children and adolescents treated with Singulair or generic montelukast between the years 2000 and 2013. Their records show 5 reported cases of suicidal ideation, 5 reports of depression, and 8 reports of agitation.
The TGA warned health care providers and caregivers of children to be watchful for such adverse events in children and adolescents, especially when initiating montelukast (Singulair) treatment or increasing dose strength.
FAERS data (from 11/01/1997 to 08/27/2012) was aggregated and standardized by the AdverseEvent RxFilter process. We identified 31,284 serious adverse events which listed Singulair as a suspect drug, while 8,168 of these reports listed Singulair or generic montelukast as the primary suspect.
The most commonly reported side effects were suicidal ideation, allergic granulomatous angiitis, and depression. We identified 2,319 hospitalizations and 342 patient deaths where Singulair or generic montelukast was determined to be the primary suspect.