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FDA warns Singulair can have serious mental health side effects in children

On Behalf of | Apr 9, 2020 | Medication Errors

Is your child’s medication putting them at risk for serious mental health issues? The Food and Drug Administration (FDA) has recently updated the asthma and allergy medication, montelukast (brand name: Singulair), with a stronger warning label.

Data from the FDA shows that doctors prescribed montelukast to an estimated 2.3 million children ages 17 or younger in 2018. The updated warning comes after an extensive review and input from a panel of experts.

What are the risks?

Risk of depression and suicidal thoughts were listed previously on the drug’s label. However, the FDA now warns that these are not the only possible side effects of this medication. Stated risks may also include:

  • Agitation
  • Obsessive-compulsive issues
  • Disorientation
  • Confusion
  • Aggressive behavior
  • Self-harm
  • Hallucinations
  • Anxiety

Many doctors, pharmacists and caregivers were unaware of these possible dangers. This is why the FDA has updated its warning label to a black box warning – highest level of warning designated for serious or life-threatening consequences.

When to act

If your child is taking montelukast, and you notice serious mood or behavioral changes in them, it is advisable to discontinue use of the drug – and contact a medical professional right away.

It’s important to note that while most reported cases resulted in symptoms resolving after stopping montelukast, it’s still possible they may continue. It’s also worth noting that mental health side effects have occurred in patients both with and without a history of mental illness.

Why is the drug still available?

The FDA notes that all medications have side effects. Your child may tolerate montelukast without any issues. In addition, the same risk of side effects has not been found in adult patients. The updated warnings do, however, recommend that physicians avoid prescribing montelukast as a first-line treatment. 

If you or your child is taking this medication, talk to your doctor about the risks and benefits. If you or your child experiences any severe or ongoing mental health consequences from this drug, it may be worth discussing your case with a medical malpractice attorney.


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