PLEASE REPORT ADVERSE REACTIONS TO SINGULAIR TO THE FDA: FDA MedWatch Adverse Event Reporting System. The FDA is monitoring ongoing reports of suicide and other psychiatric problems.
IF YOUR CHILD HAD AN ADVERSE REACTION TO SINGULAIR PLEASE PARTICIPATE IN OUR SURVEY.
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...
Our children suffered horrible adverse reactions to the popular asthma and allergy drug Singulair (montelukast sodium) manufactured by Merck & Co., Inc. While taking this drug, our sons and daughters developed symptoms consistent with behavioral, developmental, emotional, learning, anxiety, and mood disorders. Some expressed suicidal thoughts and behaviors, and some took their own lives. Many of our children were misdiagnosed for years because neither we, nor our children's doctors, had the necessary information to correctly identify their physical and behavioral symptoms as adverse reactions to Singulair. With the exception of the children that we lost, our children experienced a remission of symptoms when they stopped taking Singulair.
We areParents United for Pharmaceutical Safety and Accountability, and we are:
• 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 and a Medication Guide for Singulair • advocating for legislation to create an effective and accountable system to expedite crucial medication information to consumers, physicians, and pharmacists.
We have witnessed firsthand the crippling and devastating effects an adverse reaction to Singulair can have on children and families, and are committed to helping prevent what happened to our children from happening to anyone else.
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.**
* 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 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 (addded in October 2007), and anxiousness (February 2008).
* SINGULAIR is one of the most popular medicines in America; about 28 million prescriptions were filled in 2008.
* Neither risk factors for, nor the true incidence of adverse reactions to Singulair are 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 such reports, but physicians are not required to report their patients' adverse reactions to medications. 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 current and accurate medication information is the National Library of Medicine's DailyMed website, a database that includes FDA approved labels for over 4400 prescription drugs.
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 representatives in Congress and the Senate and ask them to take action to improve communication of 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.
* Compromised: unable to function optimally, owing to the side effects of a course of treatment.
**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.
