The agency signed off on one formulation of azelastine (Astepro).
The 0.15% strength of azelastine nasal spray is now approved for nonprescription treatment of rhinitis – a common allergy to pollens, dust mites, mold and more -- in adults and children 6 years of age or older, the agency said. The 0.1% strength remains a prescription product for younger children.
“Today’s approval provides individuals an option for a safe and effective nasal antihistamine without requiring the assistance of a health care provider,” Theresa M. Michele, MD, director of the office of nonprescription drugs in the FDA’s Center for Drug Evaluation and Research, said in a statement.
The FDA granted the nonprescription approval to Bayer Healthcare, which said in a press release that the nasal spray would be available at retail locations across the nation beginning next year.
Oral antihistamines such as cetirizine (Zyrtec), loratadine (Claritin), and fexofenadine (Allegra) have been on store shelves for years. But Azelastine 0.15% will be the first and only over-the-counter antihistamine for indoor and outdoor allergy relief in a nasal spray, Bayer said.
An over-the-counter nasal antihistamine could be a better option for some allergy sufferers when compared to what is already available, says Tracy Prematta, MD, an allergist with Delaware Valley Allergy in Havertown, PA.
“In general, I like the nasal antihistamines,” Prematta says.. “They work quickly, whereas the nasal steroids don't, and I think a lot of people who go to the drugstore looking for allergy relief are actually looking for something quick acting.”
However, the cost of the over the counter azelastine may play a big role in whether patients go with the prescription or nonprescription option, according to Prematta.
Bayer has not yet set the price for nonprescription azelastine, a company spokesperson says.
Drowsiness is a side effect of azelastine, the FDA said, meaning you need to be careful when driving or operating machinery and should avoid alcohol. Using the product with alcohol, sedatives, or tranquilizers may increase drowsiness, the agency added.
Drowsiness is also common with the oral antihistamines people take to treat their allergies, Prematta says, noting patients may also complain of dry mouth, nose, or throat.
Although some allergy sufferers dislike the taste of antihistamine nasal spray, they can try to overcome that issue by tilting the head forward, pointing the tip of the nozzle toward the outside of the nose, and sniffing gently, Prematta suggests.
“That really minimizes what gets in the back of your throat, so taste becomes less of a problem,” she says.