Cold and flu medicine including Nyquil sits on a store shelf on September 12, 2023 in Miami, Florida.
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The primary ingredient utilized in many popular over-the-counter cold and allergy medications doesn’t actually work to do away with nasal congestion, an advisory panel to the Food and Drug Administration declared Tuesday.
In a unanimous vote, 16 advisors said oral types of phenylephrine – a nasal decongestant present in versions of medication like Nyquil, Benadryl, Sudafed and Mucinex – aren’t effective at relieving a stuffy nose.
The FDA typically follows the recommendation of its advisory committees but it surely will not be required to achieve this. The agency could potentially move to start a process that removes phenylephrine from the market, which might force manufacturers to drag widely used cough and cold medications from store shelves and reformulate those products.
That might affect Procter & Gamble, the manufacturer of all versions of Nyquil, and the Johnson & Johnson spinoff Kenvue, which manufactures Tylenol and Benadryl products.
The Consumer Healthcare Products Association, a trade organization representing manufacturers and distributors of OTC drugs, said Tuesday that it’s “upset” by the advisory panel’s vote.
“We encourage FDA, before making any regulatory determination, to be mindful of the totality of the evidence supporting this long-standing OTC ingredient, in addition to the significantly negative unintended consequences related to any potential change” to phenylephrine’s regulatory status, Scott Melville, the organization’s CEO, said in a press release.
Pulling phenylephrine from the market could also affect retail pharmacy chains, which rake in revenue from selling over-the-counter cold and allergy pills.
Retail stores within the U.S. sold 242 million bottles of medication containing phenylephrine last 12 months, up 30% from 2021, in accordance with data compiled by FDA staff. Those generated $1.8 billion in sales last 12 months, the information said.
Spokespeople for CVS and Walgreens didn’t immediately reply to a request for comment.
Without oral phenylephrine, patients will likely be forced to hunt down liquid and spray versions of the drug or entirely recent medications, which weren’t included within the review by the FDA advisors.
The 2-day advisory panel meeting was prompted by researchers on the University of Florida, who petitioned the FDA to remove phenylephrine products based on recent studies showing they didn’t outperform placebo pills in patients with cold and allergy congestion.
The identical researchers also challenged the drug’s effectiveness in 2007, however the FDA allowed the products to stay available on the market pending additional research.
Yet FDA staff, in briefing documents posted ahead of the meeting this week, concluded that oral formulations of phenylephrine don’t work at standard and even higher doses. A really small amount of the drug actually reaches the nose to alleviate congestion, the agency’s staff said.