6/12/2009: Updated Information on Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)

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.

We believe a "black box" warning will more effectively alert physicians to Singulair's neuropsychiatric side effects and suicide risk, and encourage them to prescribe Singulair judiciously, warn patients about its neuropsychiatric side effects, and closely monitor patients for mood and behavior changes, depression and suicidal behavior.

Because Singulair is commonly prescribed for CHILDREN, and has side effects that are recognized by federal health agencies as warning signs and risk factors for suicide, it should carry the strongest warning the FDA can issue and be accompanied by a Medication Guide for consumers (the content of Medication Guides is regulated by the FDA; Consumer Medication Information distributed by pharmacies is not).

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Background

In April 2009, FDA completed its review of neuropsychiatric events, (mood and behavioral changes) possibly related to drugs that act through the leukotriene pathway (montelukast, zafirlukast, zileuton).  As part of its review, FDA reviewed post-marketing reports and also requested that manufacturers submit all available clinical trial data for these products.

The post-market reports of patients on these medications included cases of neuropsychiatric events.  Some reports included clinical details consistent with a drug-induced effect.  In the clinical trial data submitted by manufacturers, neuropsychiatric events were not commonly observed.  However, the available data were limited because the trials were not designed to look for neuropsychiatric events. Sleep disorders (primarily insomnia) were reported more frequently with all three products compared to placebo.


Follow-up to the March 27, 2008, Communication about the Ongoing Safety Review of Montelukast (Singulair)

FDA Flags Psychiatric Risks Of Asthma Drugs; New Labels Must Highlight Warnings Matthew Perrone, AP Business Writer, June 12, 2009

PLEASE CONTINUE TO REPORT ALL ADVERSE REACTIONS TO SINGULAIR TO FDA MEDWATCH: https://www.accessdata.fda.gov/scripts/medwatch

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Disclaimer: Parents United for Pharmaceutical Safety and Accountability is 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.