The FDA's boxed warning -- the agency's strongest -- advises against prescribing montelukast, sold as brand name Singulair, to patients with mild symptoms. It strengthens an existing warning about the risk of events such as depression and suicidal thoughts
The boxed warning advises health care providers to avoid prescribing montelukast for patients with mild symptoms. It strengthens an existing warning about the risk of neuropsychiatric events, such as agitation, depression and suicidal thoughts and actions, associated with the drug."The incidence of neuropsychiatric events associated with montelukast is unknown, but some reports are serious, and many patients and health care professionals are not fully aware of these risks," said Dr.
"Importantly, there are many other safe and effective medications to treat allergies with extensive history of use and safety," she said.The FDA reached this decision after re-evaluation of the risks and benefits of montelukast compared to other available treatments that have entered the market since the drug was first approved in 1998. It determined the risks of montelukast may outweigh its benefits, especially for people with mild allergies.
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