FDA proposes ending use of decongestant found in many cold, allergy medicines

Biotech
Friday, November 8th, 2024 4:13 pm EDT

The Food and Drug Administration (FDA) proposed on Thursday to end the use of oral phenylephrine, a common ingredient found in many over-the-counter cold and allergy medications, after concluding that it does not effectively relieve nasal congestion. This decision follows a comprehensive review of available data and comes over a year after FDA advisors unanimously reached the same conclusion. According to Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, the agency’s move is based on the finding that oral phenylephrine is not effective as a nasal decongestant, although the proposal is not based on safety concerns. The FDA emphasized that this is not yet a final decision, meaning companies can still market drugs containing the ingredient for now, but a final ruling could require the removal of hundreds of products containing oral phenylephrine from store shelves.

Phenylephrine, a nasal decongestant, is commonly used in over-the-counter medications such as NyQuil, Benadryl, Sudafed, and Mucinex. The ingredient works by constricting blood vessels in the nasal passages to reduce swelling and congestion. However, research, including studies led by the University of Florida, has demonstrated that oral phenylephrine fails to outperform a placebo in relieving nasal congestion. Despite this, the FDA allowed the product to remain on the market pending further research. After further investigation, the FDA concluded that only a small amount of phenylephrine reaches the nasal area when taken orally, thus making it ineffective as a decongestant at both standard and higher doses. This scientific evidence prompted the FDA’s proposal to revoke the ingredient’s status as “generally recognized as safe and effective,” a designation that permits certain older medicines to be sold without the need for further FDA approval.

The proposal could have significant economic and practical consequences. Retailers like CVS and Walgreens sold 242 million bottles of products containing phenylephrine in 2022, generating nearly $1.8 billion in sales. If the FDA enforces its proposal, companies like Procter & Gamble, Bayer, and Johnson & Johnson would be required to reformulate many of their popular cold and allergy medications. Consumers who rely on oral decongestants may also face challenges, as the survey by the Consumer Healthcare Products Association found that many households use oral decongestants, with a preference for them over nasal sprays by a three-to-one margin.

The history of phenylephrine as a decongestant began in 2006 when pseudoephedrine, the previous main ingredient, was restricted due to concerns about its potential use in the illicit production of methamphetamine. As a result, phenylephrine became the primary over-the-counter decongestant. The current controversy over its effectiveness follows years of scientific scrutiny and consumer advocacy. While the FDA’s decision has not been finalized, if implemented, it could lead to significant changes in the availability of cold and allergy medications, and drugmakers and retailers will likely face substantial adjustments.

For the full original article on CNBC, please click here: https://www.cnbc.com/2024/11/07/fda-decongestant-cold-medicines.html