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By Miriam E. Tucker
WebMD Health News
The 10-to-6 vote supported the Sanofi drug's switch to OTC status "for the treatment of seasonal and perennial allergic rhinitis for the temporary relief of hay fever and other respiratory allergies (nasal congestion, runny nose, sneezing, itchy nose)." Two panel members didn't vote.
The FDA is not required to follow panel recommendations, but it often does.
The age range, 2 years and older, would also be the same as for the prescription. But several committee members said they want the FDA to include specific information on the label telling people to check with a doctor before giving Nasacort to children.
If approved by the FDA, Nasacort would be the first over-the-counter steroid nasal spray. Other over-the-counter allergy medications -- antihistamines, decongestants, and mast cell stabilizers -- are considered less effective than steroids, and none treat all of the symptoms that steroid nasal sprays do.
But panel members expressed concern that people might not read all the instructions, might not know exactly what a "steroid" medication is, and might misuse it.
There was much discussion about Sanofi's proposed label advice for parents of patients 12 and younger to "tell your child's doctor when he/she starts using this medication." Some panel members noted that such an instruction would be new for an OTC product, which people generally think of as "safe."
Panel members all felt that the label would need to clearly mention potential risks to growing children.
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