Sept. 13, 2023 — America’s hottest oral nasal decongestant, phenylephrine, isn’t efficient and no higher than a placebo, an FDA panel stated Tuesday.
The unanimous vote of the Nonprescription Drug Advisory Committee was according to a evaluate of pharmacology and scientific 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the physique to be lower than 1%, in comparison with 38%, a quantity usually cited in literature and primarily based on outdated expertise.
Merchandise that include phenylephrine embody Sudafed PE, Mucinex, Dayquil, Tyenol Sinus and Advil Sinus Congestion, in addition to retailer manufacturers primarily based on the identical formulations. These merchandise can be found over-the-counter and don’t embody these bought behind pharmacy counters. The negative effects of phenylephrine embody complications, insomnia, and nervousness. At larger doses, it could actually additionally improve blood strain.
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 might 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 evaluate will take.
The evaluate additionally discovered that unique research used to help the drug’s effectiveness had been inconclusive at greatest 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 on account of its use as a possible narcotic.
Producers have used phenylephrine as an alternative of pseudoephedrine in lots of merchandise to make it simpler to purchase. Revoking the secure and efficient standing of the drug would go away sufferers with out an over-the-counter possibility.
In response to the FDA’s evaluate, 242 million packages or bottles of phenylephrine merchandise had been bought in 2022, leading to $1.76 billion in gross sales. A bit over 50 million packages of pseudoephedrine had been bought that very same yr, leading to $542 million in gross sales.
“I believe 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, stated throughout the committee assembly.
She stated 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 stated 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 actual optimistic right here to me is the chance from an academic perspective to point out shoppers the truth that there are much more methods to deal with” situations that embody congestion.
In response to the FDA evaluate, “most shoppers might merely want instruction on the alternate options, together with how one can acquire ‘behind-the-counter’ pseudoephedrine or to make use of different remedies, together with intranasal decongestants (together with intranasal PE), intranasal steroids, intranasal antihistamines, or intranasal saline merchandise.”