J
JennaM
Guest
The following warning has been added to the "Precautions" section of Singulair's label:
"Neuropsychiatric Events
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, somnarabulism, 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. Patients and prescribers should be alert for neuropsychiatric events.
Patients should be instructed to notify their prescriber if these changes occur. Prescribers should carefully evaluate the risks and benefits of continuing treatment with SINGULAIR if such events occur."
(Note: somnarabulism = sleepwalking)
Pharmacy printouts may not include this new information, or a complete list of side effects, because they are not regulated by the FDA. These printouts do advise patients to report adverse reactions to the FDA.
"Neuropsychiatric Events
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, somnarabulism, 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. Patients and prescribers should be alert for neuropsychiatric events.
Patients should be instructed to notify their prescriber if these changes occur. Prescribers should carefully evaluate the risks and benefits of continuing treatment with SINGULAIR if such events occur."
(Note: somnarabulism = sleepwalking)
Pharmacy printouts may not include this new information, or a complete list of side effects, because they are not regulated by the FDA. These printouts do advise patients to report adverse reactions to the FDA.