FDA OKs Nonprescription Allergy Drug for Young Children

From the WebMD Archives

April 4, 2001 (Washington) -- The only available nonprescription treatment for nasal allergy symptoms has now been approved for use in children as young as 2.

Pharmacia Corp. announced Wednesday that the FDA approved its application to expand the approved use of NasalCrom Nasal Spray for adults and children aged 6 and older to include children aged 2 and older. NasalCrom has been available to adults and children aged 6 and older since 1997.

NasalCrom is a mast cell stabilizer that is meant to prevent allergic reactions before they begin. The medication prevents tiny cells in the nasal passage from breaking down and releasing its chemicals that cause the allergic reaction.

"Mast cells are little time bombs that when triggered by allergens [such as pollen or mold], they burst open and release mediators that cause asthma and allergy symptoms. So NasalCrom, or cromolyn, relaxes the mast cells," says Carol Smith, MD, a specialist in asthma and allergy at Alabama Asthma and Allergy in Birmingham.

The approval was based on a study involving 200 children with allergic rhinitis, the Peapack, N.J.-based drugmaker said in a statement. That study demonstrated that approximately 40% of the children reported either no or mild symptoms after one full week of treatment, the company said.

Allergic rhinitis causes symptoms such as nasal stuffiness, runny or itchy nose, and sneezing. It generally is triggered by reactions to pollen, mold, and dust mites.

In children, it is the most common chronic disease. Experts estimate that about one in five children suffer the symptoms by age 2 or 3, and up to 40% are affected during adolescence.

If left untreated, the disease can lead to other conditions, such as asthma, ear infections, sinusitis, sleep disorders, and a chronic cough.

The most common form of prescription treatment is nasal steroid sprays. However, clinicians and parents are sometimes reluctant to use these medications because of the possible side effects.

"Parents are more comfortable with NasalCrom as first-line [therapy]," says Smith, because "it doesn't have any side effects."

According to Pharmacia, the most common side effects seen during the clinical trials were similar to those triggered by a sugar pill, or placebo. In addition, the company noted, because NasalCrom is a nonsteroidal therapy that doesn't affect the whole body, so it will not cause drowsiness or jitteriness, and it can be used safely with other medications.

It's been used for years in kids, Smith says, "and it works pretty well -- emphasis on the pretty well -- if used as directed, and that's four times a day. It's hard for anyone to do that." The key, she emphasizes, is to use it early -- before symptoms start -- and consistently.

For children with severe allergies or with co-existing conditions, such as asthma or chronic sinus problems, "NasalCrom may not work as well," Smith tells WebMD, but "there are better [prescription] medications" available.

NasalCrom initially was introduced in 1983 as a prescription medication.

With reporting by Jennifer Shelley