FDA panel votes against approval of Singulair Allergy for OTC use

Singulair FDA panel votes against approval of Singulair Allergy for OTC useA Food and Drug Administration (FDA) advisory panel is recommending that the agency not approve Merck’s Singulair Allergy drug for over-the-counter treatment for allergic rhinitis because of safety concerns.

Singulair, which contains the active ingredient montelukast, was approved in 1998 for the treatment of asthma in both children and adults. In 2002 and 2005, the indication was expanded to include the treatment for seasonal allergic rhinitis and perennial allergic rhinitis, respectively. In 2007, it was approved for exercise-induced bronchoconstriction.

Merck was seeking OTC approval of Singulair Allergy for the treatment of allergy symptoms only in adults 18 years and older, with specific wording that the OTC drug not be used as a treatment for asthma and a warning that it not be used in children younger than 18 years. Merck was requesting a dosage of 10 mg/day, which is the currently approved dosage for people 15 years and older.

The Nonprescription Drugs Advisory Committee questioned whether the safety of OTC use for the relief of allergy symptoms had been adequately demonstrated, and whether the risk/benefit profile supports OTC use in adults with hay fever and other respiratory allergies. There was also concern that despite the wording on the safety label, some patients would use the OTC drug to treat off-label conditions such as asthma and for pediatric patients.

Another concern was possible neuropsychiatric side effects, including suicide. Postmarketing studies on the Singulair have turned up reports of depression, aggression, irritability, nightmares and insomnia.

In 2007, a 15-year-old boy taking Singulair committed suicide, which prompted the FDA to conduct a safety review of drugs that work through the leukotriene pathway. The review identified 43 completed suicides between March 2008 and October 2013 in patients taking these medications. Merck updated the safety label of Singulair to caution users of the potential of neuropsychiatric events.

Part of the committee’s review included testimony from two parents who discussed neuropsychiatric events in their children after taking the drugs. The committee expressed concern whether more of these side effects would be reported if Singulair was made available over-the-counter.

The FDA is not required to follow the recommendations of its advisory panels, but it usually does.

Source: MedScape