FDA Panel Says Common OTC Decongestant Is Useless

TUESDAY, Sept. 12, 2023 (HealthDay News) -- For decades, sick people have been taking essentially worthless over-the-counter cold remedies to clear their stuffy noses, a key advisory panel for the U.S. Food and Drug Administration said Tuesday. The panel voted unanimously that nonprescription oral medications containing phenylephrine -- including Sudafed PE, Vicks Sinex, and Benadryl Allergy Plus Congestion -- do not do anything to ease congestion.

The committee's ruling could prompt the FDA to pull all oral decongestants containing phenylephrine from store shelves, leaving cold sufferers with limited options to relieve their misery, the Associated Press reported.

Phenylephrine has been available in cold remedies since the 1970s and can be taken as a liquid, pill, or nasal spray. Tuesday's decision does not include the nasal spray version. Medications with phenylephrine took on more prominence after the highly effective decongestant pseudoephedrine became harder to purchase in 2005, as part of legislation aimed at combating the meth epidemic. More than 242 million bottles or packages of phenylephrine-containing cold remedies were sold in 2022 compared with about 51 million cold products containing pseudoephedrine, FDA briefing documents for the meeting show.

But recent clinical trials, lab studies, and evidence reviews caused the FDA to question the effectiveness of phenylephrine. The more recent trials show that the current recommended dosage of phenylephrine is not effective in patients suffering from allergies, the briefing documents say.

This prompted the FDA to review the studies that had been used to approve phenylephrine. "We noted significant methodological and statistical issues with the design and conduct of the original studies submitted to and evaluated by the panel," the documents state.

The problem appears to be that the body does not absorb phenylephrine well enough to make it useful. Higher doses might work, but those doses would cause blood pressure to rise significantly. "Therefore, in addition to lack of efficacy, there may be no path to evaluating higher doses of oral phenylephrine as a nasal decongestant," the FDA concluded.

An industry group, the Consumer Healthcare Products Association (CHPA), argued against the FDA position before the agency's panel. "Considering the data from multiple clinical trials demonstrating effectiveness and decades of in-market experience, CHPA urges the panel to recognize phenylephrine's clear benefits and critical role in public health," CHPA Vice President of Regulatory & Scientific Affairs Marcia Howard, Ph.D., said in a statement to the committee.

The CHPA also asked the panel to consider the potential impact on consumers. "Simply put, the burdens created from decreased choice and availability of these products would be placed directly onto consumers and an already-strained U.S. health care system, which is why CHPA encourages the panel to consider the real-world experience and needs of consumers when making decisions that will have such broad implications," Howard added.

Associated Press Article