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New Precaution for Singulair Neuropsychiatric Events Includes Suicidal Thoughts, Behavior

Sep 2, 2009 | Parker Waichman LLP

The labels of Singulair, Accolate, Zyflo and Zyflo CR have been modified to include new information in the "Precautions" section regarding  their  association with neuropsychiatric events. In particular, the precaution for Singulair says that  "suicidal thinking and behavior" were among the neuropsychiatric events seen in that medication's post-marketing reports.

All of the drugs bearing  new neuropsychiatric precautions are approved to treat asthma, while Singulair is also approved to treat the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose), and to prevent exercise-induced asthma. Singulair and Accolate are leukotriene receptor antagonists that work by blocking leukotrienes. Zyflo and Zyflo CR are leukotriene synthesis inhibitors which work by stopping the formation of certain substances that cause swelling, tightening, and mucus production in the airways.

In March 2008, the FDA had announced that that it was reviewing the safety of Singulair because of reports linking it to neuropsychiatric events, including suicidal behavior.

This past June, the FDA announced that it had requested that the makers of Singulair, Accolate, Zyflo and Zyflo CR  include information about neuropsychiatric events in the "Precautions" section of their labels. Late last week, the agency unveiled the new label wording. For example, the precaution for Singulair is as follows:

"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."

The language for the neuropsychiatric event precautions for Accolate, Zyflo and Zyflo CR can be found here.  The Accolate precaution lists "depression and insomnia" as possible neuropsychiatric events associated with it, while the labels for Zyflo and Zyflo CR list "sleep disorder and behavioral changes."  The precautions for these medications do not include mention of suicidal thoughts or behavior.

As we've reported previously, the FDA has advised that doctors and their patients should be aware that mental issues could arise in patients taking  leukotriene modifiers and consider discontinuing the drugs if patients develop psychiatric symptoms. Patients should speak with their doctors if they experience any neuropsychiatric symptoms.


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