A mix package of Procter & Gamble Co. DayQuil Severe and NyQuil Severe brand cold and flu medicine is arranged for a photograph in Tiskilwa, Illinois.
Daniel Acker | Bloomberg | Getty Images
The important 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 versions of phenylephrine – a nasal decongestant present in versions of medicine like Nyquil, Benadryl, Sudafed and Mucinex – aren’t effective at relieving a stuffy nose.
The FDA typically follows the recommendation of its advisory committees however it isn’t required to achieve this. The agency could potentially move to start a process that removes phenylephrine from the market, which might force manufacturers to tug widely used cough and cold medications from store shelves and reformulate those products.
That would affect Procter & Gamble, the manufacturer of all versions of Nyquil, and the Johnson & Johnson spinoff Kenvue, which manufactures Tylenol and Benadryl products. Drugs with phenylephrine generated $1.8 billion in sales last yr, in keeping with data presented Monday by FDA staff.
A spokesperson for the Consumer Healthcare Products Association, a trade organization representing manufacturers and distributors of OTC drugs, didn’t immediately reply to a request for comment on the advisory panel’s vote.
Pulling cough and cold pills from the market could also force consumers to change to completely latest medications or liquid and spray versions of phenylephrine, 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 in the marketplace 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.
