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Black box warning to be added to popular asthma/allergy medicine

The FDA issued a black box warning for Singulair, or the generic form called montelukast sodium, after thousands of serious side effects are reported over 12 years.

AUSTIN, Texas — New warnings for a popular asthma and allergy drug after the FDA links the medicine to mental health issues.

The FDA issued a black box warning for Singulair, or the generic form called montelukast sodium, after studying the serious side effects for more than 12 years.

The FDA has received 14,485 reports from patients experience side effects. More than 10,000 of those are considered serious.

Many of those reports are occurring in young children and teenagers. The FDA said the warning is necessary because "we continue to receive reports of serious neuropsychiatric events with montelukast." 

There continue to be reports of serious mental health side effects from people taking this medicine, including dozens of suicides.

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Most of the time doctors and pharmacists get these warnings, but it's important that parents know about them too. According to the FDA, this is what patients should know:

  • FDA is requiring a Boxed Warning stating that serious mental health side effects that may include suicidal thoughts or actions have been reported in patients taking the asthma and allergy medicine montelukast (Singulair).
  • Most reported cases occurred during montelukast treatment, but some occurred after stopping the medicine. In many cases, symptoms resolved after stopping montelukast; however, in some cases, symptoms continued after stopping.
  • Serious mental health side effects have occurred in patients with and without a history of mental illness.
  • Talk with your health care professional about the benefits and risks of montelukast, as many other safe and effective allergy medicines are widely available, including over-the-counter ones, without a prescription. These include antihistamines such as loratadine (Alavert, Claritin), fexofenadine (Allegra), cetirizine (Zyrtec), levocetirizine (Xyzal), and diphenhydramine (Benadryl), as well as steroid nasal sprays such as fluticasone (Flonase), triamcinolone (Nasacort), and budesonide (Rhinocort). Alternatively, allergen immunotherapy, also known as allergy shots, has been shown to decrease symptoms of allergic rhinitis. A pharmacist or other health care professional can help you decide which might be best.
  • Stop taking montelukast and notify a health care professional right away if you or your child experience behavior or mood-related changes while taking the medicine. These may include:
    • agitation, including aggressive behavior or hostility
    • attention problems
    • bad or vivid dreams
    • depression
    • disorientation or confusion
    • feeling anxious
    • hallucinations (seeing or hearing things that are not really there)
    • irritability
    • memory problems
    • obsessive-compulsive symptoms
    • restlessness
    • sleepwalking
    • stuttering
    • suicidal thoughts and actions
    • tremor or shakiness
    • trouble sleeping
    • uncontrolled muscle movements
  • Talk to your health care professional about any history of mental illness before starting treatment.
  • If you have allergies, there are a number of steps you can take to lessen your symptoms. These include avoiding exposure to allergy triggers, keeping indoor air clean, and taking allergy medicines. For more information, please see Allergy Relief for Your Child.
  • We are requiring a new patient Medication Guide, which you should read every time you receive a prescription for montelukast. The Medication Guide explains the mental health risks and other important things you need to know about the medicine. These include the side effects, what the medicine is used for, how to take and store it properly, and other things to watch out for when you are taking the medicine.
  • Talk to your health care professional if you have any questions or concerns.
  • To help FDA track safety issues with medicines, report side effects from montelukast or other medicines to the FDA MedWatch program, using the information in the "Contact FDA" box at the bottom of this page.

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Merck, the maker of Singulair, sent us a statement:

"At Merck, we are committed to working with regulators, including the US Food & Drug Administration (FDA), to label our products appropriately, enabling physicians to make informed decisions about the products they prescribe.

We remain confident in the efficacy and safety of SINGULAIR (montelukast sodium), a medicine that has been prescribed to tens of millions of indicated patients with asthma and allergic rhinitis since its approval more than 20 years ago. We will work with the FDA to update the labeling for SINGULAIR. Today Merck supplies only a small portion of the overall market.

If patients have questions regarding the use of montelukast they should consult their physician."

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