Adverse Event Reports are used by the FDA to identify and evaluate safety issues with medications. Adverse event reporting by consumers and medical professionals led to the identification of hostility and sleepwalking as side effects of Singulair, and the addition to Singulair's label (prescribing information) of a precaution about neuropsychiatric side effects. The FDA continues to investigate Singulair.
The FDA also uses Adverse Event Reports to re-define the risk-benefit ratio of medications. Consumers and medical professionals should continue to report ALL adverse reactions to Singulair - even those already listed on Singulair's label.
Adverse Event Reports (with personal information omitted) become part of the public record. Agencies such as The Institute for Safe Medication Practices review the FDA AERS reports and issue their own alerts and recommendations.
IF YOUR CHILD HAD AN ADVERSE REACTION TO SINGULAIR PLEASE PARTICIPATE IN OUR SURVEY. Parents United for Pharmaceutical Safety and Accountability has received inquiries from parents wanting to know how long it takes for side effects to resolve after Singulair is discontinued, if there are withdrawal symptoms, and if there are any long term or permanent consequences of an adverse reaction. We are working to generate interest in research to answer these questions and we need your help to succeed.
SINGULAIR'S label (prescribing information) has been updated with a new precaution about neuropsychiatric side effects:
"Neuropsychiatric events have been reported in adult, adolescent, and pediatric patients taking SINGULAIR. Post-marketing reports with SINGULAIR use include agitation, aggressive behavior or hostility, anxiousness, depression, dream abnormalities, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thinking and behavior (including suicide), and tremor. The clinical details of some post-marketing reports involving SINGULAIR appear consistent with a drug-induced effect. Patients and prescribers should be alert for neuropsychiatric events. Patients should be instructed to notify their prescriber if these changes occur. Prescribers should carefully evaluate the risks and benefits of continuing treatment with SINGULAIR if such events occur."
FDA stated: "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)."
"The reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor."
FDA advised: "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."
Parents United for Pharmaceutical Safety and Accountability is pleased that the FDA has acknowledged the neuropsychiatric side effects of Singulair, and that the assertions of the many parents whose children suffered adverse reactions to this drug have been validated. We are disappointed however that the FDA is asking for a warning in the “Precautions” section of Singulair’s label instead of requiring a “black box” warning and a Medication Guide. READ MORE...
Parents United for Pharmaceutical Safety and Accountability is:
• raising awareness of the side effects of the asthma and allergy drug Singulair
• providing comprehensive information to consumers and professionals
• advocating for a "black box" warning about neuropsychiatric side effects on Singulair's label and a Medication Guide for Singulair
• advocating for research to determine: (1) how and why Singulair causes neuropsychiatirc side effects (2) how long it takes for side effects to resolve after stopping Singulair (3) whether Singulair can cause long term or permanent neuropsychiatric problems
• advocating for FDA regulation of the Consumer Medication Information distributed by pharmacies, and legislation to create an effective and accountable system to expedite medication information updates to consumers, physicians, and pharmacists.
If you are the parent of a child with asthma or allergies and are considering giving your child Singulair, or if you have already made this decision, EDUCATE YOURSELF with the information on our website. Adverse Reactions to Singulair offers an in depth explanation of Singulair's side effects. Guidelines for Parents gives tips for interacting with your child's physician, and What Everyone Should Knowexplains why self-education is so important.
And if you are the parent of a child that has had an adverse reaction to Singulair and you have experienced loss of any type, we hope you find comfort in the fact that you are not alone, and that others are working tirelessly to help change a system that allows children's mental and physical health to fall through the cracks.
* Singulair has NOT been proven the most effective drug to treat asthma or allergies:
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. Leukotriene receptor antagonists (Singulair) are considered adjunct (additional) therapy with inhaled corticosteroids, and omalizumab for severe asthma.*
* Singulair is not effective for everyone. Clinical research has determined that differential response is due in part to genetic variability.
* Approved by the FDA in February 1998, SINGULAIR is approved for use in children:
• 12 months of age and older with asthma • 2 years of age and older with seasonal allergic rhinitis (since 2002) • 6 months of age and older with perennial (year round) allergic rhinitis (since 2005) • 15 years and older for exercise induced bronchoconstriction (since 2007)
• Singulair's 10mg strength is not approved for use in children under 15.
* SINGULAIR's label has been updated multiple times to include bad/vivid dreams, irritability, restlessness (added in 2001), agitation including aggressive behavior, insomnia, hallucinations (added in 2002); tremor (added in March 2007), depression (added in April 2007), suicidal thinking and behavior (added in October 2007), and anxiousness (February 2008). Hostility and somnambulism (sleep walking) (added August 2009).
* SINGULAIR is one of the most popular medicines in America; about 28 million prescriptions were filled in 2008.
* Neither risk factors for, nor the actual incidence of, adverse reactions to Singulair is known! After a medication is approved and enters the market, adverse reactions that may not have been reported in clinical trials are identified through voluntary reports to pharmaceutical companies and the FDA's MedWatch program. Pharmaceutical companies are required to notify the FDA when they receive adverse event reports, but physicians are not required to report their patients' adverse reactions. Only those adverse reactions that are reported are considered when re-evaluating the risk/benefit ratio of a medication. READ MORE
* There is no regulated system to immediately communicate updated medication information to consumers, physicians, and pharmacists. Physicians and pharmacists may not be aware of Singulair's updated side effects or the FDA's safety review. CLICK HERE for more information.
* Consumers and healthcare providers can sign up for FDA MedWatch e-mail updates to receive updated information about medications/medical products.
* Consumer Medication Information (CMI) voluntarily provided by pharmacies is NOT regulated or approved by the FDAand may not contain a comprehensive list of side effects.CLICK HERE for more information. This news report is also informative: Drug fact sheets may omit facts consumers need.
* A reliable source of accurate medication information is the National Library of Medicine's DailyMed website, a database that includes FDA approved labels for over 4400 prescription drugs. For the most current side effect information, visit the website of the medication manufacturer and read the patient and prescribing information.
EVERYONE should be disturbed that a drug with neuropsychiatirc and serious physical side effects is frequently prescribed for children as young as 6 months of age to treat conditions for which it has NOT been proven the best treatment option. Since we cannot predict who will suffer an adverse reaction, we must assume that everyone who takes Singulair is at risk.
PLEASE help us raise awareness of Singulair's side effects so that children (and adults) will not continue to suffer needlessly.
REPORT an ADVERSE REACTION (to any medication) to FDA MedWatch
SHARE your child's RECOVERY STORY with other parents, who may be wondering how long it takes for a child to get back to "normal" after stopping Singulair.
SHARE the information on our site with others, including your and your child's physicians and pharmacists; your childcare provider; your child's preschool director; school principal, nurse, teacher, and guidance counselor; your family and friends.
ASK your physician and pharmacist to sign up for FDA MedWatch e-mail updates, concise, timely information about drugs and medical devices directly from the FDA.
ASK your physician useDailyMed to check medication information.
DEMAND CHANGE.Contact your representativesin Congress and the Senate and ask them to take action to prevent unnecessary suffering from medication side effects. JOIN our Facebook Cause: Raising Awareness of Singulair's Side Effects. Feature the cause in your profile and invite your friends to do the same.
*The EPR 3 Guidelines on Asthma were developed by an expert panel commissioned by the National Asthma Education and Prevention Program (NAEPP) Coordinating Committee (CC), coordinated by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health.
**Developed by the 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, published in the Journal of Allergy and Clinical Immunology, August 2008.
Disclaimer: Parents United for Pharmaceutical Safety and Accountabilityis a volunteer patient advocacy group. Consult a licensed healthcare professional before making any medical decisions. Do not stop administering an asthmatic child's medications without the supervision of the child's healthcare provider. The information on this site is intended for educational purposes and should not be construed as medical advice. It is accurate to the best of our knowledge. If you discover an inconsistency, please bring it to our attention.
