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Printable Side Effect Alert
   
 


FDA MedWatch Adverse Event Reporting System

FDA MedWatch e-mail updates Concise, timely information about the drugs and devices you use, prescribe, or dispense every day, directly from the U.S. FDA.

DailyMed National Library of Medicine's database of standard, up-to-date information about marketed drugs, including FDA approved labels (package inserts). NLM regularly processes data files uploaded from FDA's system and provides and maintains this Web site for the public to use in accessing the information. Additional information about medicines is available on NLM's MedlinePlus Web site http://www.nlm.nih.gov/medlineplus/medicines.html.

WebMD Drugs & Medications A-Z Over the counter medicines can also have psychiatric or behavioral side effects, which may not be listed on product packaging or product websites. Check here for possible side effects. Click on the "Does [name of drug] have any side effects?" box after clicking on the "Side Effects" tab.

consumermedsafety.org Brought to you by the Institute for Safe Medication Practices (ISMP) - the nation's only nonprofit organization of pharmacists, nurses, and doctors devoted entirely to safe medication practices. Preventing medication errors is no longer just a responsibility for health professionals - consumers like you can also play a vital role.

Center for Medication Safety

Clinicaltrials.gov registry of federally and privately supported clinical trials conducted in the United States and around the world. Information about a trial's purpose, who may participate, locations, and phone numbers for more details.

Federal Register the official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents.

Regulations.gov Source for all regulations (or rulemakings) issued by U.S. government agencies, open for public comment (i.e., proposed rules) and closed for comment (i.e., final rules) as published in the Federal Register.

Consumers Union Prescription for Change

United Kingdom Medicines and Healthcare Products Regulatory Agency Drug Prints   Post-marketing medication adverse reactions reports. Reports for Singulair are listed under "montelukast."


PERSONAL ACCOUNTS OF ADVERSE REACTIONS TO SINGULAIR

International SINGULAIR (Montelukast) Side Effects Action Group

Making the side effects of singulair aware to parents of children & teens

medications.com

patientsville.com this site also publishes FDA Adverse Event Reports

askapatient.com

psychcentral.com

healthboards.com


INFORMATION ABOUT SINGULAIR

Adverse Events Reported to FDA in 2008

Montelukast and psychiatric disorders in children June 2009 This study evaluated psychiatric adverse events during treatment with montelukast in children and concluded that further studies are needed to establish the magnitude of the problem.

FDA Approval Histories, Letters, Reviews, and Related Documents for Singulair

FDA Medical Review for Singulair 10 MG Depression and insomnia were documented in a clinical study (pages 84-86 of the PF or pages 78-80 on the document)

FDA Medical Review for Singulair 5 MG Chewable Depression and insomnia were documented in children taking montelukast (Singulair) in a clinical study (page 24 of the PDF or page 21 on the document)

FDA Medical Review for Singulair 4 MG Chewable

FDA Medical Review for Singulair Granules Part 1

FDA Medical Review for Singulair Granules Part 2

Canadian "Product Monograph" for Singulair 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 a clinical study of 175 pediatric patients 6 months to 2 years of age, This information is not included in the "Adverse Reactions" section of Singulair's US label.

Singulair 4 mg granules “Local Prescribing Information” for healthcare professionals in UAE, Bahrain, Kuwait and Qatar – text revised December 2003 Also lists HYPERKINESIA 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, This information is not included in the "Adverse Reactions" section of Singulair's US label.

Montelukast, a Once-Daily Leukotriene Receptor Antagonist, in the Treatment of Chronic Asthma A Multicenter, Randomized, Double-blind Trial Archives of Internal Medicine, Vol. 158 No. 11, June 8, 1998, Original Investigation
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Refer to the SAFETY section for the reasons (including anxiety and depression) that participants in the montelukast group discontinued treatment.

Singulair and Depression eMedTV, January 15, 2009
Depresion was reported as an adverse event in the clinical trials for Singulair

Singulair-increases-risk-of-Suicide---Dont-just-poo-poo-the-possibility David Engler, MD, The Allergy Clinic. April 2008. Dr. Engler has served two terms on the Board of Regents of the American College of Allergy, Asthma & Immunology, and has represented that organization at the A.M.A.

On September 20, 2006 the database of the Netherlands Pharmacovigilance
Centre Lareb contained four reports of depressive reactions associated with the use of montelukast
 The same day the database of the WHO contained 3466 reports on montelukast, 43 of them concerning depression.

Individual case safety reports in children in commonly used drug groups – signal detection Sweden, March 2008. This study indicates that Adverse Drug Reactions are reported for commonly used drugs in children.  A possible signal for montelukast and psychiatric adverse drug reactions was found, which should be further explored.

Anti-Leukotrienes for Asthma May Mask Airway Inflammation: Presented at CHEST November 2001. Anti-leukotriene monotherapy for asthma may not prevent long-term airway deterioration

Montelukast Is Not Effective in Controlling Allergic Symptoms Outside the Airways
Based on the current results, montelukast should not be recommended as a general drug to treat all the symptoms of atopic syndrome, but it should be considered as a drug for asthma and rhinitis.


EOSINOPHILIA, VASCULITIS AND CHURG-STRAUSS

Eosinophilia NYU Langone Medical Center

Eosinophilia National Institutes of Health

National Heart, Blood and Lung Institutet What Is Vasculitis?

Churg-Strauss Syndrome Association

Churg-Strauss Syndrome - NIH

A severe systemic inflammatory reaction following therapy with montelukast (Singulair®)  Nephrol Dial Transplant (2000), Lasse G. Gøransson and Roald Omdal.

Montelukast and Churg-Strauss Syndrome Turkish Respiratory Journal, Füsun Topçu, Levent Akyıldız, Tekin Yıldız, Kenan İltumur, Faruk Oktay, Nihal Kılınç.CSS does not appear to relate to steroid tapering in our patient. Long-term data on these drugs are lacking and leukotriene's role in vasculitis remains to be elucidated. Cardiac involvement in CSS, may present as a serious course. The blockade of the cysteinyl leukotriene receptors could provoke an imbalance in leukotriene receptor stimulation, leading to an increase in circulating LTB4. This leukotriene is a strong chemoattractant for neutrophils and eosinophils and could trigger an eosinophilic state, and thereby intitiate vasculitic involvement.

Churg–Strauss syndrome and leukotriene antagonist use: a respiratory perspective
Thorax Online, May 2008, N. Nathani, M A Little, H Kunst, D Wilson, D R Thickett. Authors conclude that based on the available clinical evidence there is a suggestion of a causal relationship between LTA and CSS. Respiratory physicians need 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.

Montelukast and Churg-Strauss syndrome Swiss Med Weekly, 2004, David Conena, Jörg Leuppib, Lukas Bubendorfc, Anke Ronsdorfa, Michael Tammb, Thomas Hauserd. Almost 150 cases of LRA associated CSS have been reported by the US FDA...An as yet unknown direct pathogenic effect of these drugs appears to be possible...Given the various, inconclusive reports, a controlled study with a large number of patients is needed...clinicians should be aware of this rare but potentially severe complication of LRA.

Churg–Strauss syndrome in two patients receiving montelukast Oxford Journals, Rheumatology 2002, P. Guilpain, J.-F. Viallard, P. Lagarde, P. Cohen, M. Kambouchner, J.L. Pellegrin and L. Guillevin. Both patients presented with CSS after 4–5 months of treatment with montelukast. Neither patient received long-term systemic steroids for asthma, but both were on inhaled steroids.

Montelukast and Churg-Strauss syndrome Thorax online 2002, R Solans, J A Bosch, A Selva, R Orriols, M Vilardell. To our knowledge, no case of CSS relapse has previously been reported in association with leukotriene antagonists.

The linkage between Churg-Strauss syndrome and leukotriene receptor antagonists: fact or fiction? Therapeutics and clinical risk management, June 2005, Deanna L McDanel and Barbara A Muller.


INFORMATION ABOUT ASTHMA AND ALLERGIES

NIH National Heart Lung and Blood Institute: What Is Asthma?

The National Asthma Education and Prevention Program (NAEPP)
recommends that for all age groups, inhaled corticosteroids are the most effective medication for long-term control.

Asthma Risk for Behavioral, Emotional, Developmental Problems Researchers at the University of Virginia Children's Hospital evaluated data collected in a survey conducted by the Centers for Disease Control and Prevention. According to the study, parents of kids with asthma were twice as likely to report that their child has severe problems with behavior, emotions, concentration, or getting along with others. THIS ARTICLE DOES NOT DISCUSS THE ROLE OF ASTHMA MEDICATIONS AS A CONTRIBUTING FACTOR.

AsthmaMoms.com

Allergy and Asthma Network Mothers of Asthmatics

The Food Allergy & Anaphylaxis Network

Some scented household products contain chemicals classified as toxic, UW study finds The Seattle Times July 2008

Natural Air Fresheners Green Living Ideas

Fruit and Vegetable Diet 'could Prevent Asthma'


INFORMATION ABOUT COMPLIMENTARY AND ALTERNATIVE
TREATMENTS FOR ASTHMA AND ALLERGIES

Asthma is a serious disease. If you decide to treat your or your child's asthma symptoms with natural products, consult a licensed health professional. Supplements and herbs can be harmful if used incorrectly.

National Center for Complimentary and Alternative Medicine, National Institutes of Health

National Library of Medicine MedLinePlus: Dietary Supplements

National Library of Medicine MedLinePlus: Herbal Medicine

The American Association of Naturopathic Physicians

American Institute of Homeopathy

Optimum Nutrition Approach to Asthma

SEVEN WAYS TO STOP ASTHMA

Little Allergies Allergen Block


INFORMATION ABOUT FDA and RELATED ISSUES

H.R. 3580, the Food and Drug Administration Amendments Act of 2007

Law Strengthens FDA RE: H.R. 3580

FDAAA Implementation – Highlights One Year After Enactment

MEMORANDUM OF AGREEMENT BETWEEN THE OFFICE OF NEW DRUGS AND OFFICE OF SURVEILLANCE AND EPIDEMIOLOGY IN THE FDA CENTER FOR DRUG EVALUATION AND RESEARCH

Columbia Classification Algorithm of Suicide Assessment (C-CASA): Classification of Suicidal Events in the FDA’s Pediatric Suicidal Risk Analysis of Antidepressants 

National Conference of State Legislatures re: FDA Final Rule on Prescription Drug Labeling 

FDA Requiring Suicide Studies in Drug Trials Gardiner Harris New York Times Jan 2008

FDA mandates suicide studies in clinical drug trials New England Psychologist

FDA Won't Test All Drugs for Psychiatric Problems Pharmalot Business Blog, May 2008

Many Trial Reports on FDA-Approved Drugs Go Unpublished  washingtonpost.com. September 2008.

Despite Vow, Drug Makers Still Withhold Data Alex Berenson New York Times May 2005

No Redemption for Preemption Doug Bremner, MD, Huffington Post, September 8, 2008

Bush administration pressured FDA to undermine safety Public Citizen October 29, 2008

Docs often write off patient side effect concerns Reuters Health August 2007

FDA Requires Side Effects Statement on Labeling PharmTech November 2008