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From the FDA's "Updated Information on Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)"

6/12/2009

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).

Montelukast is used to treat asthma, and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose), and to prevent exercise-induced asthma. Zafirlukast and zileuton are used to treat asthma.

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.

This information reflects FDA’s current analysis of available data concerning this drug.

Advice to patients and healthcare professionals:

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.

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.

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I'd like to hear more clarification from the FDA and Merck on the following media statements:
"Merck believes that the data support the continued use of Singulair in appropriate patients with asthma and allergic rhinitis.”
But, the agency also noted that the trials were not designed to examine such behavior, and that the safety review will continue, probably for several more months."
If the trials were not designed to examine psychiatric events what good is the data and why would it take 9 months to rehash submitted data that does not contain appropriate information?
Another statement that needs clarification is, "Merck believes that the data support the continued use of Singulair in appropriate patients with asthma and allergic rhinitis.”
Why such careful wording as "appropriate patients"? That is to suggest that Singulair is "inappropriate" for some, perhaps many people.
Lastly, "We have finished our analyses of all the data the companies submitted," FDA spokeswoman Karen Riley told the Associated Press. "But that doesn't mean we have closed the book on suicidality."
My questions are were there any unsubmitted data and why would they leave the book open unless there were a legitimate reason to?
This is definitely not over and as well it should not be.