FDA Requests Labelling Change for Asthma Medications
Posted Jun 14 2009 11:23pm
The US Food and Drug Administration (FDA) today provided further updated safety information on leukotriene modifiers.
The FDA has requested that manufacturers include a precaution in the drug labelling regarding neuropsychiatric events that have been reported in some persons taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR).
The reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behaviour (including suicide), and tremor.
Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications.
Healthcare professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms.
The US Food and Drug Administration (FDA) today provided further updated safety information on leukotriene modifiers.
The FDA has requested that manufacturers include a precaution in the drug labelling regarding neuropsychiatric events that have been reported in some persons taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR).
The reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behaviour (including suicide), and tremor.
Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications.
Healthcare professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms.
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