Decongestant in Popular Cold and Allergy Medicines Found to Be Ineffective, According to FDA Advisors

An advisory panel to the Food and Drug Administration (FDA) has stated that the main ingredient used in many popular over-the-counter cold and allergy medications does not effectively relieve nasal congestion. The panel unanimously voted that oral forms of phenylephrine, a nasal decongestant found in drugs like Nyquil, Benadryl, Sudafed, and Mucinex, are not effective at treating a stuffy nose.

While the FDA typically follows the advice of its advisory committees, it is not obligated to do so. The agency may choose to initiate a process to remove phenylephrine from the market, which would require manufacturers to withdraw cough and cold medications from store shelves and reformulate their products.

This decision could impact Procter & Gamble, the manufacturer of all versions of Nyquil, as well as Johnson & Johnson and its spinoff Kenvue, which produce Tylenol and Benadryl products.

The Consumer Healthcare Products Association, a trade organization representing manufacturers and distributors of over-the-counter drugs, expressed disappointment with the panel’s vote. The organization’s CEO, Scott Melville, urged the FDA to consider the overall evidence supporting phenylephrine’s use before making any regulatory decisions.

If phenylephrine is removed from the market, it could also affect retail pharmacy chains, which generate revenue from selling over-the-counter cold and allergy pills. Data compiled by FDA staff revealed that retail stores in the U.S. sold 242 million bottles of drugs containing phenylephrine last year, amounting to $1.8 billion in sales.

Without oral phenylephrine, patients will likely need to turn to liquid and spray versions of the drug or seek out alternative medications. However, these alternatives were not included in the FDA advisors’ review.

The advisory panel meeting, which lasted for two days, was prompted by researchers at the University of Florida. They petitioned the FDA to remove phenylephrine products based on recent studies showing that they were no more effective than placebo pills in treating congestion caused by cold and allergies. The same researchers challenged the drug’s effectiveness in 2007, but the FDA allowed the products to remain on the market pending further research.

In briefing documents posted before the meeting, FDA staff concluded that oral forms of phenylephrine do not work at standard or higher doses. Only a small amount of the drug actually reaches the nose to relieve congestion, according to the agency’s staff.