People’s Pharmacy: Is there a way to petition the FDA to change a drug’s classification?

Q. Why isn’t Singulair (montelukast) available over the counter? It has a better safety profile than antihistamines and is safe in children. How does one advocate for a generic drug to change its classification to OTC?

A. The Food and Drug Administration has approved montelukast to treat asthma, exercise-induced bronchoconstriction (trouble breathing) and allergic rhinitis. It is not approved for use during an acute asthma attack.

We wish that this oral medicine were as safe as you suggest. Drug companies are required to warn prescribers that it may trigger serious neuropsychiatric events, including aggression, agitation, depression, suicidal thoughts and even suicide. These reactions may not be common, but as a result, the FDA notes, “the benefits of montelukast sodium may not outweigh the risks in some patients.” Other side effects include severe allergic reactions to the drug itself and seizures.

It makes sense for such a medicine to be available, as the FDA recommends, “for patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies.”

Readers have described undesirable reactions to this medicine. One mother wrote: “My 10-year-old happy child was put on montelukast and became very sad and depressed. As soon as we took him off montelukast, his happy disposition returned.”

A wife reported: “My husband took this drug for asthma and allergies and experienced severe, debilitating episodes of depression. It got so bad that he became suicidal. This drug should be taken off the market, as it is extremely dangerous.”

Such reactions make a medicine inappropriate for OTC use.