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 unanimous vote of the Nonprescription Drug Advisory Committee was consistent with 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by the physique to be lower than 1%, in comparison with 38%, a quantity usually cited in literature and based mostly on outdated know-how.
Merchandise that include phenylephrine embrace 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 embrace these offered behind pharmacy counters. The uncomfortable side effects of phenylephrine embrace complications, insomnia, and nervousness. At greater doses, it may additionally improve blood stress.
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 Protected and Efficient (GRASE) must be revoked. This might imply producers must provide you with new formulations, or merchandise containing the drug could be faraway from retailer cabinets. The committee didn’t say how lengthy the evaluate will take.
The evaluate additionally discovered that authentic research used to help the drug’s effectiveness have 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 as a consequence 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 protected and efficient standing of the drug would depart sufferers with out an over-the-counter choice.
In line with the FDA’s evaluate, 242 million packages or bottles of phenylephrine merchandise have been offered in 2022, leading to $1.76 billion in gross sales. Just a little over 50 million packages of pseudoephedrine have been offered that very same yr, leading to $542 million in gross sales.
“I believe 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 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 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 optimistic 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 embrace congestion.
In line with the FDA evaluate, “most customers could merely want instruction on the alternate options, together with get hold of ‘behind-the-counter’ pseudoephedrine or to make use of various remedies, together with intranasal decongestants (together with intranasal PE), intranasal steroids, intranasal antihistamines, or intranasal saline merchandise.”