Medicine - Xagena

Neuropsychiatric events have been reported in some patients taking Montelukast ( Singulair ), Zafirlukast ( Accolate ), and Zileuton ( Zyflo and Zyflo CR ).
The FDA ( Food and Drug Administration ) has requested that manufacturers include a precaution in the drug prescribing information.

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.

In April 2009, FDA completed its review of neuropsychiatric events, ( mood and behavioral changes ) possibly related to drugs that act through the leukotriene pathway.
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.

Source: FDA, 2009

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