FDA reviews OTC Singulair use

Inappropriate use in children under 15 years old and patients seeking relief for asthma cited as top concerns.

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HealthDay News –  The FDA is considering the asthma drug montelukast (Singulair) for over-the-counter use. 

Currently, montelukast requires a prescription. The medication's patent expired in mid-2012, and generic versions of the drug have reduced montelukast's sales, reported the drug's manufacturer, Merck.

Approximately 33.3 million patients were prescribed montelukast from 2002-2012, the agency said in a briefing document from the Nonprescription Drugs Advisory Committee Meeting.

If the FDA approves OTC use, montelukast will compete with other OTC antihistamines like Claritin, and nasal sprays like Nasacort.

The agency has noted its concerns about montelukast's proposed OTC use, stating it may be used inappropriately by teenagers, as the drug is not suited for children under the age of 15.

“Another potential safety issue for OTC use of montelukast is the possibility of OTC use in patients with asthma, since montelukast is approved as a prescription product for asthma,” said the FDA. “It is unclear if consumers would attempt to treat their asthma symptoms using montelukast rather than seeking care from a health care professional.”

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