(NBC NEWS) — The FDA is requiring its strongest warning for a popular asthma and allergy drug.
The agency has announced it is issuing a “boxed warning” for montelukast which is sold under the brand name of Singulair.
The new label will advise doctors to avoid prescribing the medication for mild symptoms especially those with hay fever.
The drug has carried a warning since 2008 about a link with an increased risk of depression, sleeping problems, and suicidal thoughts.
However, the FDA says a review of data last year shows the risks may outweigh the benefits in some patients.
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