FDA ISSUES REMINDER TO HEALTH PROFESSIONALS ABOUT THE RISK OF NEUROPSYCHIATRIC EVENTS WITH LEUKOTRIENE INHIBITORS, MONTELUKAST [SINGULAIR], ZAFIRLUKAST [ACCOLATE], ZILEUTON [ZYFLO, ZYFLO CR]
Recently, the FDA’s Pediatric Advisory Committee recommended that health professionals be reminded about the risk of neuropsychiatric events with leukotriene inhibitors, montelukast [Singulair], zafirlukast [Accolate], zileuton [Zyflo, Zyflo CR]. Although this is not a new safety signal, the public raised concern that health professionals were not aware of the safety issue and not informing patients about the risk of neuropsychiatric events.
The reported neuropsychiatric events include post-market cases of agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide), and tremor.
For more detailed information, read an expert interview on the topic at FDA’s For Health Professionals website.
Advice to Health Professionals
Communicate the potential for neuropsychiatric events when initiating therapy. Instruct patients to notify their provider if neuropsychiatric events occur. Monitor for neuropsychiatric events during the course of treatment, and consider discontinuing therapy if such events occur. Report adverse events to MedWatch, FDA’s adverse event reporting program.
I encourage you to distribute this information widely. Thank you for your support of the FDA and our mission,
Shannon Thor, PharmD Health Programs Coordinator Office of Health & Constituent Affairs Office of External Affairs U.S. Food and Drug Administration Tel: 301.796.8645 Shannon.Thor@fda.hhs.gov
September 2014 - The 13 member Pediatric Advisory Committee to the US Food and Drug Administration called for clarifications on labels and for a new letter to providers about Singulair's neuropsychiatric side effects.
"The public testimony phase of the meeting heard from Jan Gilpin, a member of the group Parents United for Pharmaceutical Safety and Accountability, formed in 2009 over concerns that children had developed mental and development issues while on montelukast."
"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, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, 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 [see Adverse Reactions (6.2)]."
IT ALSO CARRIES A WARNING ABOUT EOSINOPHILIC CONDITIONS
"Patients with asthma on therapy with SINGULAIR may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy. These events have been sometimes associated with the reduction of oral corticosteroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal association between SINGULAIR and these underlying conditions has not been established [see Adverse Reactions (6.2)]."
This information is current as of October 22, 2013. Check the actual Prescribing Information (link above) in the event changes were made after this date.
* Singulair has NOT been proven the safest and 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 (including Singulair) are considered adjunct (additional) therapy with inhaled corticosteroids, and omalizumab for severe asthma.* (Inhaled corticosteroids are not side effect free.)
* Singulair is not effective for everyone. Clinical research has determined that differential response is due in part to genetic variability.
• 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), anxiousness (added February 2008), hostility and somnambulism (sleep walking); Precaution about Neuropsychiatric Side Effects (added August 2009), disorientation (2010). The most recent additions are disturbance in attention and memory impairment.
* 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. Healthcare Providers may not be aware of Singulair's updated side effects. 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 16,000 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 serious neuropsychiatirc and 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 safest and most effective 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 raise awareness of Singulair's side effects so that children (and adults) will not continue to suffer needlessly.
SHARE your child's RECOVERY STORY with other parents, who may be wondering how long it takes side effects to resolve.
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 healthcare providers to sign up for FDA MedWatch e-mail updates, concise, timely information about drugs and medical devices directly from the FDA.
ASK your healthcare provider to check medication information on DailyMed.
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*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 health care 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.