The FDA suggests discontinuing the use of a decongestant commonly found in cold and allergy medications.

• The FDA suggested discontinuing the use of a widely used ingredient in many over-the-counter cold and allergy medications as it does not alleviate nasal congestion.
• The FDA has not finalized the proposed order, so companies can continue marketing over-the-counter drugs containing oral phenylephrine for the time being.
• Hundreds of products containing oral forms of a specific ingredient will be cleared from pharmacy shelves due to a final order, which is present in versions of drugs such as NyQuil, Benadryl, Sudafed, and Mucinex.

The Food and Drug Administration on Thursday suggested discontinuing the use of a widely-used component in numerous over-the-counter cold and allergy remedies.

An extensive review of available data has determined that oral phenylephrine does not actually relieve nasal congestion. This conclusion was reached more than a year ago by advisors to the FDA.

Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, stated in a release that "we are taking the next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant."

The FDA has stated that the proposed order is not based on safety concerns and is not yet final, allowing companies to continue marketing over-the-counter drugs containing oral phenylephrine. However, a final decision would require pharmacies to remove hundreds of products containing oral forms of the ingredient, which is found in versions of drugs such as NyQuil, Benadryl, Sudafed, and Mucinex.

Last year, it was reported that certain medicines containing oral phenylephrine had already been pulled.

Drugmakers such as Bayer and spinoff would need to reformulate many of their oral cold and allergy products to meet the final order.

The FDA's decision not to approve oral phenylephrine means that patients will likely resort to alternative methods to relieve congestion, such as nasal sprays or other medications with different ingredients.

In 2022, retail stores such as CVS sold 242 million bottles of drugs containing phenylephrine, generating nearly $1.8 billion in sales, according to a presentation by FDA staff last year.

The FDA has the authority to remove the "generally recognized as safe and effective" designation for a drug, which would require drugmakers to submit an application to the FDA before including the ingredient in over-the-counter products. This designation is typically used for older medicines.

The FDA advisors' meeting last year was triggered by researchers from the University of Florida, who urged the agency to remove phenylephrine products from the market due to studies indicating that they were no better than placebo pills in treating cold and allergy congestion in patients.

In 2007, the same researchers questioned the drug's effectiveness, but the FDA permitted the products to remain on the market until more research was conducted.

According to FDA staff, oral formulations of phenylephrine are ineffective at standard or higher doses because only a small amount of the drug reaches the nose to relieve congestion.

During the meeting last year, the Consumer Healthcare Products Association, which represents over-the-counter drug manufacturers, did not present any new evidence to challenge the FDA staff's conclusion regarding phenylephrine.

The group contended that removing oral phenylephrine from the market would greatly affect consumers.

A survey shared by the group revealed that 1 out of every 2 households in the U.S. utilized an oral decongestant in the past year, while nasal spray was preferred by a ratio of 3:1.

In 2006, phenylephrine became the primary decongestant in over-the-counter cold and allergy medicines after the sales of pseudoephedrine were restricted in the U.S.

The pharmacy countered the misuse of pseudoephedrine by placing it behind the counter, as it can be used to produce methamphetamine, a highly addictive stimulant drug that affects the central nervous system.