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FDA is requiring a Boxed Warning stating that serious neuropsychiatric events that may include suicidal thoughts or actions have been reported in patients taking montelukast (Singulair).
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Sep 7, 2023 · The FDA issued a boxed warning for Singulair in 2020 because of serious behavior and mood-related side effects, such as depression and suicidal thoughts. Learn about the symptoms, alternatives and lawsuits related to Singulair side effects.
- What Is Montelukast Used for?
- What Prompted The FDA’s Decision?
- What Are The Mental Health Risks Associated with Montelukast?
- What Should I Do If I Currently Take Montelukast?
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Montelukast is an oral, prescription-only medication. It’s used to prevent and treat asthma in adults and children ages 2 years and older. It’s also used to relieve symptoms of allergic rhinitis. It works by blocking the effects of inflammatory chemicals called leukotrienes, which cause your airways to narrow or swell. The FDA approved the brand ve...
This isn’t the first time the FDA has looked into the link between montelukast and mental health side effects. In 2008 and 2009, Merck, Singulair’s manufacturer, updated the drug’s labeling four times to account for reported side effects of tremors, anxiousness, depression, and suicide. During this time, the FDA asked Merckto conduct more studies o...
Behavioral and mood-related side effects are possible with montelukast. Specifically, the FDA has issued warnings about side effects like: 1. Agitation and aggression 2. Irritability 3. Confusion 4. Hallucinations 5. Memory changes 6. New or worsening depression 7. Sleeping problems, including vivid dreams and sleepwalking 8. Suicidal thoughts and ...
Because of this updated safety warning, the risks of montelukast may outweigh the benefits for some people. If you’re currently taking montelukast, check in with your provider and ask about montelukast’s risks and benefits for you. In general, you should only take montelukast if you can’t tolerate other medicines or they do not work for you. This i...
Montelukast (Singulair) is a prescription drug for asthma and allergies that can cause depression, suicidal thoughts, and other behavioral changes. The FDA issued a boxed warning, their strongest safety alert, in 2020 based on reports of these side effects.
Jan 9, 2024 · The agency’s label, which was primarily aimed at doctors, was supposed to sound an alert about the 25-year-old medication, Singulair, also known by its generic name, montelukast. But it barely ...
Jan 14, 2022 · Montelukast (Singulair) is a prescription drug for asthma and allergy, but it can cause serious behavior and mood-related changes, including suicidal thoughts or actions. FDA requires a Boxed Warning and a patient Medication Guide to inform users of the risks and benefits of montelukast.
The U.S. Food and Drug Administration (FDA) is strengthening existing warnings about serious behavior and mood-related changes with montelukast (Singulair and generics), which is a prescription...
Mar 9, 2020 · The allergy and asthma drug Singulair can cause suicidal thoughts and other neuropsychiatric events, according to the FDA. The agency advises against prescribing the drug for people with mild symptoms, especially hay fever, and suggests alternative treatments.
