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:

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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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Excerpt from:

Black box warning to be added to popular asthma/allergy medicine - KVUE.com