Rejection of Montelukast as an OTC drug by FDA Panel (Singulair allergy)

In an 11-4 voting, the FDA’s Non- prescription Drugs Advisory Committee voted against approving Singulair,which is being used for allergy and asthma, to be made available for over- the-counter sale for the treatment of allergic rhinitis.

Montelukast has been a prescription medicine for the treatment of asthma since1998, for seasonal AR since 2002, for perennial AR since 2005, and for exercise induced bronchoconstriction since 2007. 

The drug’s manufacturer, Merck & Co. Inc., submitted an application, to receive an approval for selling Singulair ( brand name) as an OTC product for allergies, but not for asthma. It would have been marketed under the name of  ” Singulair Allergy”, in order to differentiate it from the prescription product.  The company asked for approval on a partial addition to OTC for adults 18 years old and older only, and only for the treatment of allergy symptoms, with specifically defining, the not to be used OTC for asthma treatment, along with a specific warning on not to be used by children younger than 18 years.  

Reason for rejection: that asthma could be a life threatening condition,  and should be managed with a health care provider. But once  this product available OTC, it could be difficult to stop patients with asthma from purchasing the drug and self treating, they could also give up other prescription medications in favor of OTC Singulair. Patients could also end up mixing their drug’s which they are using for asthma with this product for their allergy relief, especially when self medicating. It was also questioned that what effect OTC use for allergies might have on patients who are already taking Montelukast as a prescription.  This could also lead to patients increasing the dose by themselves when suffering from an allergy. 

Another concern was it’s side effect, potential association with neuropsychiatric events, including suicidality. The suicide of a 15 year old boy taking Montelukast in 2007  was 1 event prompting the review, according to FDA documents. Merck then added in their labels a precaution against neuropsychiatric events, which ws then approved in 2009 by FDA. But committee were not satisfied with labeling as a solution to uncertainties.  


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