Sept. 13, 2023 -- America's most popular oral nasal decongestant, phenylephrine, is not effective and no better than a placebo, an FDA panel said Tuesday.
The unanimous vote of the Nonprescription Drug Advisory Committee was in line with a review of pharmacology and clinical data the FDA presented Monday. It found the rate at which the drug is absorbed by the body to be less than 1%, compared to 38%, a number often cited in literature and based on outdated technology.
Products that contain phenylephrine include Sudafed PE, Mucinex, Dayquil, Tyenol Sinus and Advil Sinus Congestion, as well as store brands based on the same formulations. These products are available over the counter and do not include those sold behind pharmacy counters. The side effects of phenylephrine include headaches, insomnia, and nervousness. At higher doses, it can also increase blood pressure.
The Nonprescription Drug Advisory Committee discussed the efficacy and how phenylephrine moves in the body. The committee's next move is to determine if the drug's status as Generally Recognized as Safe and Effective (GRASE) should be revoked. This would mean manufacturers would have to come up with new formulations, or products containing the drug would be removed from store shelves. The committee did not say how long the review will take.
The review also found that original studies used to support the drug’s effectiveness were inconclusive at best and contained potential methodological, statistical, and data integrity issues.
Pseudoephedrine is the only other nonprescription oral nasal decongestant on the retail market but is behind-the-counter due to its use as a potential narcotic.
Manufacturers have used phenylephrine instead of pseudoephedrine in many products to make it easier to buy. Revoking the safe and effective status of the drug would leave patients without an over-the-counter option.
According to the FDA's review, 242 million packages or bottles of phenylephrine products were sold in 2022, resulting in $1.76 billion in sales. A little over 50 million packages of pseudoephedrine were sold that same year, resulting in $542 million in sales.
"I think there's a huge potential for consumer concern," Diane B. Ginsburg, PhD, the pharmacy practice division associate dean for health care partnerships at the University of Texas, said during the committee meeting.
She said patients may be confused and concerned about the panel vote, especially those people who feel they have benefitted from phenylephrine products. In the event of its status as safe and effective is removed, she said doctors should reassure patients that phenylephrine is being pulled from shelves because it’s ineffective, and not because it is dangerous.
"The real positive here to me is the opportunity from an educational perspective to show consumers the fact that there are a lot more ways to treat" conditions that include congestion.
According to the FDA review, "most consumers may simply need instruction on the alternatives, including how to obtain 'behind-the-counter' pseudoephedrine or to use alternative treatments, including intranasal decongestants (including intranasal PE), intranasal steroids, intranasal antihistamines, or intranasal saline products."