New Suicide Precaution for Singulair
The label for the asthma drug Singulair has been updated to include information about neuropsychiatric events, including suicidal thoughts and behavior. A similar precaution for Accolate, Zyflo and Zyflo CR has also been added to their labels, but those precautions do not include wording on sucide.
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.”
