FDA Approves Nasal Antihistamine to Treat Allergy Symptoms

There is some hopeful news for the millions of people in the United States experiencing allergy symptoms.

They can now get an antihistamine nasal spray for adult and childhood seasonal allergies. The Food and Drug Administration (FDA) approved the over-the-counter use of Astepro (azelastine hydrochloride nasal spray, 0.15 percent) last week.

Dr. Theresa Michele, director of the office of nonprescription drugs in the FDA’s Center for Drug Evaluation and Research, said in a press release that the approval provides people with an option for a safe and effective nasal antihistamine without requiring the assistance of a healthcare professional.

The 0.1 percent-strength version of Astepro, which includes the year-round allergy indication for children 6 months to 6 years old and a seasonal allergy indication for children ages 2 to 6, will still require a prescription.

What you need to know

Reducing histamine reactions to allergens is about keeping your nose clean. When an allergen enters your body, your immune system kicks into defense mode, attacking the foreign substance.

The typical allergic reaction, which includes stuffy, runny nose, and sneezing, is your body’s attempt to remove the allergen from your respiratory system.

When a reaction occurs, nasal sprays provide targeted administration directly to the symptom site.

Dr. Leonard Bielory, an allergist and immunologist, said antihistamine nasal sprays help maximize control of the effects of histamine, the most common mediator of allergy.

Histamines are naturally produced neurotransmitters or chemical messengers that communicate with your brain, digestive system, and immune system, telling these systems about the allergen and the need for defense.

Such alternative medicine or complementary solutions work to decrease the interaction of pollen with nasal mucosa triggering sites (mast cells), Bielory said.

Bielory lists nasal saline as one of these nonmedication solutions.

He also mentions formulas with essential oils (e.g., mint-containing herbal formulations have similar claims in which peppermint oil actually contains two primary components, menthone and menthol, which are interrelated). Examples of these formulas include Sinusol, Hydrasense, and BioMint.

Whether or not you need a spray with an active medical ingredient is a discussion to have with your doctor, depending on your health history and allergy severity.

Precautions and side effects

Using Astepro is not entirely risk-free.

The label warns consumers that using Astepro can cause drowsiness and that using azelastine nasal sprays along with alcohol, sedatives, or tranquilizers may increase drowsiness.

People who use the product are urged to be cautious when driving a motor vehicle or operating machinery.

If you have chronic allergic reactions or other respiratory conditions that require a longer-term use of a medicated type of spray, pay attention to how well the medication is working after a period of time.

Also, keep in mind that just because you don’t have to see a doctor to access this medication, it would still be a good idea to talk with a primary care physician about whether or not this treatment may work for you. They can also help you learn more about other options available.

“Long-term use of medicated solutions may induce tolerance, and some such as intranasal steroids have rarely been reported to associated nose bleeds (epistaxis) and even more rarely nasal septum perforation,” Bielory said.

If you notice adverse reactions from using nasal spray or you’ve developed a tolerance to the medication, talk with your doctor about other possible options, including seeing an allergy specialist who can help with longer-term management strategies.

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