In an update to an earlier communication, FDA announced that the manufacturers of the leukotriene inhibitors montelukast (Singular), zafirlukast (Accolate), zileuton (Zyflo), and zileuton extended-release (Zyflo CR) are adding information about neuropsychiatric events to product labeling.
In an update to an earlier communication, FDA announced that the manufacturers of the leukotriene inhibitors montelukast (Singular), zafirlukast (Accolate), zileuton (Zyflo), and zileuton extended-release (Zyflo CR) are adding information about neuropsychiatric events to product labeling.
Neuropsychiatric events such as agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior, and tremor have been reported in patients treated with these agents.
The agency recommends that patients and healthcare professionals should be aware of the potential for these adverse events to occur, and healthcare professionals should consider discontinuing treatment with these agents if patients develop neuropsychiatric symptoms.
Timothy Grass Pollen Allergen Extract approved by FDA
April 16th 2014FDA has approved the Timothy Grass Pollen Allergen Extract (Grastek, Merck) sublingual tablet as immunotherapy to treat grass pollen-induced allergic rhinitis with or without conjunctivitis in children as young as 5 years of age and adults up to the age of 65. The tablet is a new option for patients who decline allergy shots.
Sublingual immunotherapy for allergic rhinitis and asthma effective, JAMA reports
April 2nd 2013In an examination of a type of treatment for allergic rhinitis and asthma that is used in Europe but not approved by FDA, researchers found moderate strength in the evidence from previous studies to support the use of sublingual immunotherapy for the treatment of these conditions, according to a review article in the March 27 issue of JAMA.