FDA Warns of Serious Mood Changes with Allergy Drug Montelukast
Leukotriene modifiers have emerged as a potential first-line treatment for both allergy-induced asthma and allergic rhinitis. However, the FDA has issued a boxed warning for montelukast (Singulair) due to serious behavioral and mood changes, including suicidal thoughts and actions.
Leukotrienes are fatty immune system chemicals that trigger severe allergy symptoms, such as nasal passage swelling, increased mucus production, and asthma symptoms like shortness of breath and wheezing. These chemicals are released when the immune system, mistakenly treating a harmless foreign protein as an invader, responds to allergens.
Leukotriene modifiers are drugs that limit leukotriene production or block their binding to receptors. They are used to treat asthma and allergic rhinitis. Montelukast (Singulair) and zafirlukast (Accolate) are examples of leukotriene receptor antagonists. Zileuton (Zyflo) indirectly inhibits leukotriene synthesis.
Common side effects of leukotriene modifiers include headache, stomach pain, indigestion, fever, stuffy nose, cough, rash, dizziness, and fatigue. In rare cases, mood changes, nervousness, or sleep disturbances may occur. These can also include insomnia, agitation, aggression, anxiety, and mood changes. The FDA requires a boxed warning for montelukast due to the risk of serious behavioral and mood changes.
Leukotriene modifiers, while potentially effective in treating allergy-induced asthma and allergic rhinitis, come with serious side effects. It is crucial for patients to be aware of these potential mood changes and report any concerns to their healthcare provider.
