ATLANTA, Ga. (Atlanta News First) - A pending decision from the Food and Drug Administration regarding popular common nasal decongestants could disrupt the over-the-counter medication market, pharmacists warn.
An FDA advisory panel voted unanimously Tuesday against the effectiveness of the key drug found in popular versions of Sudafed, Dayquil, and other medications stocked on store shelves. The 16-person panel concluded oral medicines containing phenylephrine don’t work to get rid of nasal congestion.
The advisers came to the decision after looking at research that shows when taken orally, only a small amount of the drug reaches the nose. It does not include nasal sprays and prescription medication.
Ira Katz, owner of Atlanta’s Little Five Points, said he wasn’t surprised by the panel’s decision. However, he warned the removal of the ingredient could “wreak havoc” on over-the-counter products this cold and flu season.
“If they take it off, all of these products are going to have to be revamped, totally revamped and the cost to the manufacturers will be exuberant which will be trickled down to the consumer,” Katz said.
Phenylephrine became the main drug in over-the-counter decongestants 15 years ago when regulators learned an older ingredient was being used to make methamphetamine.
The FDA has not indicated when it will make a final decision on the matter but the agency typically sides with its advisory committees.
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Pending decision over nasal decongestants could ‘wreak havoc,’ pharmacists warn - Atlanta News First
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