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 | Singulair (montelukast), a popular medication for the treatment of allergic rhinitis and asthma, has been rejected by a subcommittee of the U.S. Food and Drug Administration (FDA) for over-the-counter (OTC) use. While this ruling by the FDA Subcommittee on Non-Prescription Drugs is not an official ruling, the FDA usually follows the recommendations of its subcommittees. Merck, the manufacturer of Singulair, had sought approval for OTC use for the purpose of treating allergic rhinitis, and not for the purpose of treating asthma. The FDA subcommittee cited two concerns with approving Singulair for OTC use. First, the FDA felt that people would be aware that Singulair also treats asthma, and therefore people using OTC Singulair might stop taking their other asthma inhalers, which could result in worsening asthma control. Second, the FDA still has concerns regarding the side effects of Singulair, especially mood and behavior changes. Therefore, it appears that Singulair (and it's generic version, montelukast), will be available only by prescription for the immediate future. |
| Singulair for the Treatment of Allergies
Singulair (montelukast), a once-daily prescription medication, was developed a number of years ago for the treatment of asthma. In recent years, it was discovered that Singulair was also effective for the treatment of allergic rhinitis. Singulair is not an antihistamine, rather, it blocks another mediator of inflammation, called leukotrienes.
| Side Effects of Singulair
In April 2009, the Food and Drug Administration (FDA) finished its review of the clinical information regarding the possibility that Singulair (montelukast) is related to psychiatric side effects. Reported symptoms include agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor.
| OTC Medications for Allergies
There are numerous over-the-counter (OTC) medications available for the treatment of allergy symptoms. Some of these, like oral decongestants such as Sudafed (pseudoephedrine) and sedating antihistamines like Benadryl (diphenhydramine), have been available for many years. Others, such as Claritin (loratadine) and Zyrtec-D (cetirizine/pseudoephedrine), have only recently become available OTC without a prescription.
| Ragweed Sublingual Tablet and Another Grass Tablet Approved
The U.S. Food and Drug Administration (FDA) this week approved another sublingual grass immunotherapy tablet (Grastek) as well as a sublingual ragweed immunotherapy tablet (Ragwitek). The approval of Grastek comes... Read more
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