Sept. 13, 2023 — America’s hottest oral nasal decongestant, phenylephrine, shouldn’t 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 Usually Acknowledged as Secure and Efficient (GRASE) must be revoked. This is able to 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 evaluation will take.
The unanimous vote was consistent with a evaluation 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the physique to be lower than 1%, in comparison with 38%, a quantity typically cited in literature and based mostly on outdated know-how.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 could additionally enhance blood strain.
The evaluation additionally discovered that unique research used to assist 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 resulting from 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 choice.
Based on the FDA’s evaluation, 242 million packages or bottles of phenylephrine merchandise had been offered in 2022, leading to $1.76 billion in gross sales. A bit of over 50 million packages of pseudoephedrine had been offered that very same 12 months, leading to $542 million in gross sales.
“I feel there’s an enormous potential for shopper concern,” Diane B. Ginsburg, PhD, the pharmacy observe division affiliate dean for well being care partnerships on the College of Texas, mentioned through the committee assembly.
She mentioned sufferers could also be confused and anxious in regards to 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 mentioned 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 actual constructive 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” circumstances that embody congestion.
Based on the FDA evaluation, “most shoppers could merely want instruction on the options, together with the right way 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.”
