FDA panel deems ingredient in over-the-counter nasal decongestant ineffective
Click Here to Manage Email Alerts
An FDA panel today voted unanimously against the efficacy of oral phenylephrine, an ingredient in many nasal decongestants sold over the counter to treat colds and allergy symptoms.
During the Nonprescription Drug Advisory Committee, panel members reviewed updated data on oral phenylephrine, often referred to as PE. Ultimately, panelists determined the data indicated oral PE was no more effective than placebo. Their discussion did not apply to nasal formulations of the drug.
Zachary E. Rubin, MD, a pediatric allergist and spokesperson for the American College of Allergy, Asthma and Immunology, told Healio that he was not surprised by the decision and that he has not recommended oral PE for his patients.
“Multiple randomized, placebo controlled clinical trials did not show that oral phenylephrine was superior to placebo in treating nasal congestion,” he said. “This medication has been under scrutiny for quite some time.”
The FDA is not required to follow the recommendations of its advisory panels, but it usually does. In this case, that may mean calling for the removal of oral PE from popular cold and allergy medicines, such as Sudafed PE, Benadryl Allergy Plus Congestion and some forms of Mucinex.
In materials provided by the FDA to the panelists, the Clinical and Clinical Pharmacology teams reported results of their evaluation of data that had been published since the last meeting on oral PE in 2007. Their review showed that the bioavailability of oral PE is less than 1%, although outdated technology had previously shown a bioavailability of 38%.
Data also showed that clinically relevant pharmacodynamic changes, including an increase in systolic and diastolic blood pressure, only occur at doses of 80 mg to 100 mg.
Further, results of three clinical trials showed no difference in 10 mg doses of oral PE every 4 hours, doses of up to 40 mg of oral immediate-release phenylephrine hydrochloride salt, or two different 30 mg extended-release formulations compared with placebo. Although the review deemed doses up to 40 mg ineffective, they also wrote that it would not be feasible to study higher doses considering safety concerns.
“We believe that these new clinical pharmacology and clinical data are consistent, substantial and believable, and they confirm that orally administered PE is not effective at any dose that can be developed and still provide a reasonable margin of safety,” the reviewers wrote.
In a statement from the trade group Consumer Healthcare Products Association (CHPA), Scott Melville, CHPA president and CEO, expressed disappointment with the FDA panel’s recommendation.
“We encourage FDA, before making any regulatory determination, to be mindful of the totality of the evidence supporting this long-standing OTC ingredient, as well as the significantly negative unintended consequences associated with any potential change in oral PE’s regulatory status,” Melville said.
“While we respect the scientific and public process that allows new science to influence health policy and regulations,” he continued, “we are concerned about previous clinical evidence being inappropriately dismissed and discounted. We look forward to working with FDA in the coming days to further discuss how to best move forward in the interest of patients and consumers.”
Phenylephrine replaced pseudoephedrine in many OTC cold and allergy medicines due to the misuse of pseudoephedrine, which a 2006 law dictated had to be sold behind pharmacy counters.
Rubin noted that other decongestants are available for relief and that physicians should be able to guide their patients to appropriate treatment.
“If someone is struggling with nasal congestion and find that over-the-counter medications are not helping, then talking with their doctor about further treatment options would be helpful,” he said. “They may need to see a specialist such as an allergist to address these issues.”
References:
- AP. Popular nasal decongestant doesn’t actually relieve congestion, FDA advisers say. Available at: https://apnews.com/article/sudafed-decongestants-phenylephrine-pseudoephedrine-fda-0f140bafae9a500c5fba05fe764ecb66. Published Sept. 12, 2023. Accessed Sept. 12, 2023.
- CHPA. Statement following the September 2023 meeting of the Nonprescription Drugs Advisory Committee (NDAC) to evaluate new data concerning the efficacy of oral PE. https://www.chpa.org/news/2023/09/statement-following-september-2023-meeting-nonprescription-drugs-advisory-committee. Published Sept. 12, 2023. Accessed Sept. 12, 2023.
- FDA Briefing Document. Efficacy of oral phenylephrine as a nasal decongestant. Available at: https://www.fda.gov/media/171915/download. Accessed Sept. 12, 2023.