Sept. 13, 2023 — America’s hottest oral nasal decongestant, phenylephrine, will not be efficient and no higher than a placebo, an FDA panel mentioned Tuesday.
The Nonprescription Drug Advisory Committee mentioned the efficacy and the way phenylephrine strikes within the physique. The committee’s subsequent transfer is to find out if the drug’s standing as Typically Acknowledged as Secure and Efficient (GRASE) needs to be revoked. This is able to imply producers must give you new formulations, or merchandise containing the drug can be faraway from retailer cabinets. The committee didn’t say how lengthy the overview will take.
The unanimous vote was consistent with a overview of pharmacology and medical knowledge the FDA introduced Monday. It discovered the speed at which the drug is absorbed by the physique to be lower than 1%, in comparison with 38%, a quantity typically cited in literature and based mostly on outdated know-how.
Merchandise that comprise phenylephrine embody Sudafed PE, Mucinex, Dayquil, Tyenol Sinus and Advil Sinus Congestion, in addition to retailer manufacturers based mostly on the identical formulations. These merchandise can be found over-the-counter and don’t embody these offered behind pharmacy counters.
The uncomfortable side effects of phenylephrine embody complications, insomnia, and nervousness. At larger doses, it will probably additionally enhance blood stress.
The overview additionally discovered that authentic research used to help the drug’s effectiveness had been inconclusive at finest and contained potential methodological, statistical, and knowledge integrity points.
Pseudoephedrine is the one different nonprescription oral nasal decongestant on the retail market however is behind-the-counter attributable to its use as a possible narcotic.
Producers have used phenylephrine as a substitute of pseudoephedrine in lots of merchandise to make it simpler to purchase. Revoking the secure and efficient standing of the drug would depart sufferers with out an over-the-counter possibility.
In line with the FDA’s overview, 242 million packages or bottles of phenylephrine merchandise had been offered in 2022, leading to $1.76 billion in gross sales. Somewhat over 50 million packages of pseudoephedrine had been offered that very same yr, leading to $542 million in gross sales.
“I feel there’s an enormous potential for client concern,” Diane B. Ginsburg, PhD, the pharmacy observe division affiliate dean for well being care partnerships on the College of Texas, mentioned in the course of the committee assembly.
She mentioned sufferers could also be confused and anxious concerning the panel vote, particularly these individuals who really feel they’ve benefitted from phenylephrine merchandise. Within the occasion of its standing as secure and efficient is eliminated, she mentioned medical doctors ought to reassure sufferers that phenylephrine is being pulled from cabinets as a result of it’s ineffective, and never as a result of it’s harmful.
“The true constructive right here to me is the chance from an academic perspective to point out customers the truth that there are much more methods to deal with” situations that embody congestion.
In line with the FDA overview, “most customers could merely want instruction on the alternate options, together with tips on how to acquire ‘behind-the-counter’ pseudoephedrine or to make use of various therapies, together with intranasal decongestants (together with intranasal PE), intranasal steroids, intranasal antihistamines, or intranasal saline merchandise.”
