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Singulair's Side Effects
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Printable Side Effect Alert
   
 


We urge you to take Singulair's side effects very seriously and ask that you share the information on this website with your colleagues.

*Side effects can manifest 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. 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.

*It is unknown how long it takes for side effects to resolve after stopping Singulair. Parents have been reporting that side effects took days, weeks, months or longer to completely resolve.

* Inhaled corticosteroids are the most effective medication for long term control of ashtma symptoms, according to the National Asthma Education and Prevention Program (NAEPP) Clinical Practice Guidelines, which considers Singulair adjunct therapy.


* 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.


* Singulair is not effective for everyone. The inter-patient variability in response is substantial (25-60% response rate), which is due in part to genetic variability. Genetic variation in leukotriene pathway candidate genes contributes to variability in montelukast response.

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.)


* Anti-Leukotrienes for Asthma May Mask Airway Inflammation: Presented at CHEST Anti-leukotriene monotherapy for asthma may not prevent long-term airway deterioration.


* 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 2003 hyperkinesia 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.


* The posts on our "Recovery Stories" page offer a unique opportunity for you 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.


* Urge patients to sign up for FDA MedWatch e-mail updates. We urge you to sign up also.


* Notify your patients when you learn that medication information, including side effects, has been updated. 


* 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