Sept. 13, 2023 — America’s hottest oral nasal decongestant, phenylephrine, will not be efficient and no higher than a placebo, an FDA panel stated 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 Usually Acknowledged as Secure and Efficient (GRASE) ought to be revoked. This may imply producers must provide you with 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 in keeping with a overview of pharmacology and medical knowledge the FDA offered 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the physique to be lower than 1%, in comparison with 38%, a quantity usually cited in literature and primarily based on outdated know-how.
Merchandise that comprise 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 increased doses, it may possibly additionally enhance blood strain.
The overview additionally discovered that authentic 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 because of 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 protected and efficient standing of the drug would go away 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 bought in 2022, leading to $1.76 billion in gross sales. A little bit over 50 million packages of pseudoephedrine had been bought that very same 12 months, 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, stated through 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 protected and efficient is eliminated, she stated docs 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 optimistic right here to me is the chance from an academic perspective to indicate shoppers the truth that there are much more methods to deal with” situations that embody congestion.
In line with the FDA overview, “most shoppers could merely want instruction on the alternate options, together with easy methods to receive ‘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.”