FDA Panel Rejects OTC Status for Singulair Allergy Drug

in Asthma
Published: May 12, 2014

In an 11 to 4 decision, the FDA’s Non-prescription Drugs Advisory Committee has voted against approving Singular, an allergy and asthma tablet, for over-the-counter sale.

The drug’s manufacturer, Merck & Co. Inc., had filed an application to sell Singular (a brand name for the drug montelukast) as an OTC product for allergies, but not asthma, for adults 18 and over. It would have been marketed under the name “Singulair Allergy” to differentiate it from the prescription product.

Currently, Singulair is prescribed to both adults and children for relief of asthma or allergy symptoms. It works by blocking leukotrienes, which are molecules that play a role in asthma and allergy inflammation.

The FDA committee expressed a variety of concerns with the proposed approval. The reason that the proposal indicated the drug would only be used for allergies, not asthma, is that asthma is a condition that can be life-threatening and should always be managed with a health-care provider.

But once available OTC, the FDA committee said it might be difficult to stop patients with asthma from purchasing the drug and self-treating, possibly even giving up other prescription medications in favor of OTC Singulair. While the label was to say that the pills were not for those under the age of 18, the committee said this would be difficult to prevent.

Another concern is side effects. In 2009 the label for Singulair was updated to include a list of potential “neuropsychiatric” side effects, which include “agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior, and tremor.” The side effects are reported to be rare, but would have been considered in considering Singulair for OTC status.