In a recent development, an FDA panel has stated that phenylephrine, America's most popular oral nasal decongestant, is not effective and is no better than a placebo. TheNonprescription Drug Advisory Committee discussed the drug's efficacy and its movement in the body. The committee will now decide whether to revoke the drug's status as Generally Recognized as Safe and Effective (GRASE). If this happens, manufacturers will have to create new formulations, or products containing phenylephrine will be taken off store shelves. The duration of this review process was not specified.
The FDA's unanimous vote aligns with a review of pharmacology and clinical data that was presented earlier. This review found that the drug's absorption rate in the body is less than 1%, contradicting the commonly cited figure of 38% based on outdated technology. Known phenylephrine-containing products include Sudafed PE, Mucinex, Dayquil, Tyenol Sinus, Advil Sinus Congestion, and store brands with similar formulations. These products are available over the counter and do not include those sold behind pharmacy counters.
Phenylephrine has side effects such as headaches, insomnia, and nervousness. At higher doses, it can also raise blood pressure. Additionally, the original studies that supported the drug's effectiveness were inconclusive and potentially flawed in terms of methodology, statistics, and data integrity.
Pseudoephedrine is the only other nonprescription oral nasal decongestant on the retail market. However, it is only available behind the pharmacy counter due to its potential use as a narcotic. Manufacturers have opted for phenylephrine in many products to make them more accessible. If the safe and effective status of phenylephrine is revoked, patients will lose their over-the-counter option.
In 2022, approximately 242 million packages or bottles of phenylephrine products were sold, generating $1.76 billion in sales. By comparison, around 50 million packages of pseudoephedrine were sold, resulting in $542 million in sales during the same year.
Diane B. Ginsburg, PhD, the pharmacy practice division associate dean for health care partnerships at the University of Texas, expressed concern about potential consumer confusion regarding the panel's vote. She emphasized the need for doctors to reassure patients that phenylephrine is being removed from shelves due to its ineffectiveness, not because it poses a danger.
In light of this situation, the FDA review suggests that most consumers may need guidance on alternative treatments, such as obtaining behind-the-counter pseudoephedrine or using intranasal decongestants, steroids, antihistamines, or saline products. This presents an opportunity for education and raising awareness about the various options available to treat conditions that involve congestion.