"Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling)."
FDA advised that:
Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications.
Patients should talk with their healthcare providers if these events occur.
Healthcare professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms.
"Neuropsychiatric symptoms" include: agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor.
Sleep disorders (primarily insomnia) were reported more frequently with all three products compared to placebo.
These side effects are currently listed in the "Post-marketing Experience" section of Singulair's Prescribing Information,which was updated in August 2009 to include hostility and somnambulism (sleep walking) as side effects, and a new precaution about neuropsychiatric side effects.
*Adverse reactions to Singulair can occur at any time during treatment with Singulair. Parents have been reporting to Parents United for Pharmaceutical Safety and Accountability that their children began experiencing side effects days, weeks, months, and even years after treatment with Singulair was initiated. Additionally, some parents reported they observed side effects only after a dosage increase. Parents have also reported that side effects worsened, and/or additional side effects manifested after a dosage increase.
* Intranasal corticosteroids are the preferred treatment for both seasonal and perennial allergic rhinitis, and effectively treat both early and late phase responses. Adverse reactions usually are limited to the nasal mucosa, with rare systemic effects.*
* Read the publications about Montelukast and Churg-Strauss Syndrome on our Links and Resources page. These reports suggest the possibility of a causal relationship, highlight the need for controlled research, and advise physicians to be aware of the risk of CSS when treating patients with asthma with LTAs. Patients should be made aware of the signs and symptoms of CSS after initiation of LTA therapy and they should be regularly monitored for complications.
Do NOT give a child the adult dosage if the children's dosage is not adequately controlling their symptoms!
The dosage for adults and adolescents 15 years of age and older is one 10 mg tablet. The dosage for pediatric patients 6 to 14 years of age is one 5 mg chewable tablet. The dosage for pediatric patients 2 to 5 years of age is one 4 mg chewable tablet or one packet of 4 mg oral granules. The dosage for pediatric patients 12 to 23 months of age for the treatment of asthma, or for pediatric patients 6 to 23 months of age for the treatment of perennial allergic rhinitis is one packet of 4 mg oral granules.
The mean systemic exposure of the 4 mg chewable tablet in pediatric patients 2 to 5 years of age and the 5 mg chewable tablets in pediatric patients 6 to 14 years of age is similar to the mean systemic exposure of the 10 mg tablet in adults.
Clinical trials in adults and adolescents 15 years of age and older demonstrated there is no additional clinical benefit to montelukast doses above 10 mg once daily. (From Singulair's Prescribing Information, CLINICAL PHARMACOLOGY section.)
* If a parent suspects their child is having an adverse reaction to Singulair that is not listed in Singulair's US prescribing information, do not dismiss their concerns! For example, according to the Canadian "Product Monograph" for Singulair, in a clinical study of 175 pediatric patients 6 months to 2 years of age, hyperkinesia was reported as a drug related adverse experience in >1% of patients treated with Singulair and at a greater incidence than in patients treated with placebo. In Singulair 4 mg granules “Local Prescribing Information” for healthcare professionals in UAE, Bahrain, Kuwait and Qatar – text revised December 2003hyperkinesia is listed as a drug related adverse experience in >1% of patients treated with Singulair and at a greater incidence than in patients treated with placebo in a clinical study of 175 pediatric patients 6 months to 2 years of age. Asthma is also listed as a drug related adverse experience in this age group. Thirst is listed as a drug related adverse experience in 2 to 5 year olds treated with Singulair in both documents. We could not find this information in Singulair's US prescribing information.
* Read the consumer experiences with Singulair posted on our "Recovery Stories" page to learn what patients and parents are saying about Singulair's side effects. Links to other websites with personal accounts are on our "Links and Resources" page.
* Before you make a diagnosis of a behavioral, developmental, emotional, learning, or psychiatric disorder in a child taking Singulair, stop treating the child with Singulair to see if symptoms resolve.
* Reevaluate any prior diagnoses of the above disorders that were made after a patient started taking Singulair.
* When prescribing medications, discuss all the options with patients/parents. Explain what the side effects are. Allow them to make educated decisions about the medications they and their children will take.
* Inform patients/parents that the CMI leaflets they receive from their pharmacy are neither approved nor regulated by the FDA and may not be up to date or contain comprehensive information.
* The web-based database you use to access medication information might not be up to date or contain comprehensive information.DailyMed is the National Library of Medicine's website that includes current labels for over 16,000 FDA approved medications, including Singulair. Be aware, however, that this database may not immediately reflect prescribing information updates.
* Notify your patients when you learn that medication information, including side effects, has been updated.
* When prescribing maintenance medications, initially prescribe a one month supply, and require an office visit before issuing another prescription. At this checkup review all the side effects with the patient again. Continue to reveiw side effects regularly.
*Report adverse reactions to the FDA.
* Do not allow pharmaceutical companies to influence your prescribing practices.
* Refer to the work of J. Douglas Bremner, MD, Professor of Psychiatry and Radiology and Director of the Emory Clinical Neuroscience Research Unit (ECNRU) at Emory University School of Medicine in Atlanta, Georgia, and Director of Mental Health Research at the Atlanta VAMC in Decatur, Georgia. Dr. Bremner researched the connection between Accutane and depression. He performs research using brain imaging to look at the effects of medications on the brain and brain correlates of mental disorders. He is a board-certified psychiatrist and nuclear medicine physician and has authored or co-authored over 200 peer reviewed articles and book chapters and three books, including Before You Take that Pill: Why the Drug Industry May be Bad for Your Health: Risks and Side Effects You Won’t Find on the Label of Commonly Prescribed Medications, Vitamins and Supplements.
*Joint Task Force on Practice Parameters, representing the American Academy of Allergy, Asthma & Immunology; the American College of Allergy, Asthma and Immunology; and the Joint Council of Allergy, Asthma and Immunology
