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What are the side effects of Montair?

4 min read

According to the U.S. Food and Drug Administration (FDA), the asthma and allergy drug montelukast, sold under the brand name Montair, carries a boxed warning due to the risk of serious neuropsychiatric side effects, including suicidal thoughts and actions. While the medication is effective for many, it is crucial to understand what are the side effects of Montair before starting treatment.

Quick Summary

An overview of Montair (montelukast) side effects, from common issues like headache and nausea to rare but serious adverse reactions, including psychiatric changes and liver problems. The FDA's boxed warning regarding mental health risks is also discussed.

Key Points

  • FDA Boxed Warning: The FDA has placed a boxed warning on montelukast, the active ingredient in Montair, for serious and potentially life-threatening neuropsychiatric side effects, including suicidal thoughts and behavior.

  • Psychiatric Monitoring: Patients and caregivers must monitor for mood or behavior changes, such as anxiety, depression, agitation, aggression, and sleep disturbances, and report them to a doctor immediately.

  • Common Side Effects: Common adverse reactions include headache, stomach pain, nausea, diarrhea, and upper respiratory infection.

  • Rare Serious Side Effects: Though rare, serious physical side effects like Churg-Strauss syndrome and liver problems can occur.

  • Not for Acute Attacks: Montair is not a rescue medication for sudden asthma attacks and should not be used for this purpose.

  • Evaluate Benefits and Risks: Prescribers and patients should carefully evaluate the benefits versus the risks, especially for mild conditions where other therapies might be suitable.

  • Immediate Discontinuation: If serious neuropsychiatric symptoms appear, Montair should be stopped immediately, and a healthcare provider contacted.

In This Article

Montair, known by its generic name montelukast, is a prescription medication used to manage and prevent symptoms of asthma and allergic rhinitis (hay fever). It works by blocking substances in the body called leukotrienes, which cause inflammation and constriction in the airways. While generally well-tolerated, it is associated with a range of side effects, from mild and common to rare and potentially severe.

Common side effects of Montair

Most people who take Montair experience mild side effects, if any. These often resolve on their own as the body adjusts to the medication. Common side effects reported include:

  • Headache: One of the most frequently reported side effects.
  • Gastrointestinal issues: Abdominal pain, diarrhea, nausea, and vomiting.
  • Upper respiratory infections: Symptoms such as fever, cough, sore throat, and a runny or stuffy nose.
  • Fatigue and dizziness: Some patients report feeling unusually tired or dizzy.
  • Rash: A mild skin rash can sometimes occur.

Serious neuropsychiatric side effects: An FDA boxed warning

In March 2020, the FDA required a boxed warning for montelukast, highlighting the risk of serious mental health side effects. These effects can be severe and life-threatening and have been reported in both adults and children, with some symptoms occurring even after the medication is stopped. Patients and caregivers should be vigilant for the following:

  • Mood and behavior changes: This includes agitation, aggression, anxiety, depression, hostility, irritability, and restlessness.
  • Sleep disturbances: Abnormal or vivid dreams, nightmares, insomnia, and sleepwalking have been reported.
  • Cognitive issues: Problems with attention, memory impairment, and confusion can occur.
  • Other severe symptoms: Tremors, hallucinations, and obsessive-compulsive behaviors have been reported.
  • Suicidal ideation: In rare but serious cases, patients have experienced suicidal thoughts and actions.

If you or someone you know experiences any of these symptoms while taking Montair, stop the medication and contact a healthcare professional immediately. The FDA advises healthcare providers to reserve montelukast for allergic rhinitis only when other treatments are ineffective or not tolerated.

Rare but serious physical side effects

Beyond the neuropsychiatric risks, other rare but serious adverse reactions can occur with Montair:

  • Churg-Strauss Syndrome: Also known as eosinophilic granulomatosis with polyangiitis (EGPA), this rare autoimmune disorder involves the inflammation of blood vessels. Symptoms may include flu-like illness, worsening asthma, rash, and a pins and needles sensation in the limbs. It is important to note that this condition is sometimes associated with the reduction or withdrawal of oral steroid therapy in asthma patients also taking montelukast.
  • Liver problems: While uncommon, liver injury and elevated liver enzyme levels have been reported. Symptoms can include abdominal pain, itching, dark-colored urine, pale stools, and jaundice (yellowing of the skin or eyes).
  • Severe allergic reactions: Hypersensitivity reactions, including angioedema (swelling of the face, lips, tongue, or throat), hives, and anaphylaxis, are possible and require immediate medical attention.

Factors increasing risk and important warnings

Certain factors can increase the risk of adverse effects from Montair:

  • Pre-existing mental health conditions: Patients with a history of mental illness may be at a higher risk for neuropsychiatric side effects. It's vital to inform your doctor about your complete mental health history.
  • Aspirin sensitivity: Montelukast does not modify the bronchoconstrictor response to aspirin in sensitive individuals. Therefore, patients with known aspirin sensitivity should continue to avoid aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs).
  • Liver problems: Patients with a history of liver disease should use Montair with caution.
  • Acute asthma attacks: Montair is a long-term control medication and should not be used to treat an acute asthma attack. A short-acting inhaler is needed for immediate relief during an attack.

Comparison of Montair side effects

Understanding the frequency and nature of side effects can help in monitoring and managing them effectively. The following table compares common and serious adverse reactions.

Side Effect Category Common Side Effects Rare/Serious Side Effects
Psychiatric/Neurological Headache, dizziness, drowsiness Aggression, anxiety, depression, agitation, insomnia, suicidal thoughts, hallucinations, memory problems, obsessive-compulsive symptoms
Gastrointestinal Abdominal pain, diarrhea, nausea, vomiting Hepatitis, liver injury
Respiratory Upper respiratory infection, cough, sore throat Churg-Strauss Syndrome (vasculitis), increased eosinophil levels
Hypersensitivity Mild rash Angioedema, anaphylaxis
Other Fever, fatigue Increased bleeding tendency, thrombocytopenia, seizures

Conclusion

Montair is an important and effective medication for the long-term management of asthma and allergic rhinitis for many people. However, the existence of both common and serious side effects, particularly the documented psychiatric risks, necessitates careful consideration. The FDA's boxed warning underscores the need for heightened awareness from both healthcare providers and patients. It is imperative to discuss any potential risks with a doctor before starting treatment and to continuously monitor for any unusual mood, behavior, or physical changes. In cases where alternative therapies may be effective, especially for mild allergic rhinitis, a doctor might recommend those options to avoid the risks associated with Montair.

For more detailed information, consult the MedlinePlus drug information page for montelukast: https://medlineplus.gov/druginfo/meds/a600014.html.

Frequently Asked Questions

Yes, Montair (montelukast) can cause serious psychiatric side effects, for which the FDA has issued a boxed warning. These can include agitation, anxiety, depression, hallucinations, and suicidal thoughts or actions.

You should stop taking Montair and contact a healthcare professional immediately if you or your child experience any behavioral or mood-related changes. Symptoms can include agitation, anxiety, irritability, depression, or suicidal thoughts.

While montelukast has few known drug-specific interactions, it's advised to limit alcohol consumption because both alcohol and Montair can affect the liver, potentially increasing the risk of liver problems. Patients with aspirin sensitivity should continue to avoid NSAIDs.

No, Montair is a long-term control medication and is not meant to be used for a sudden asthma attack. Patients should use a short-acting, or 'rescue,' inhaler for acute symptoms.

Montair is approved for use in children, but parents and caregivers should be aware of the increased risk of certain neuropsychiatric reactions, such as nightmares and aggression, in the pediatric population. Close monitoring is essential.

No, you should not stop taking Montair without consulting your doctor, even if you feel well. Stopping abruptly can lead to a worsening of your condition.

Churg-Strauss syndrome (EGPA) is a rare, severe autoimmune condition involving blood vessel inflammation that has been reported in rare cases with montelukast. It is sometimes linked to reducing oral steroid doses. Symptoms include rash, flu-like symptoms, and numbness.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.