Widespread OTC Decongestants Don’t Actually Work, FDA Says

Sept. 13, 2023 — America’s hottest oral nasal decongestant, phenylephrine, isn’t 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 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 in step with a overview of pharmacology and medical information 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by the physique to be lower than 1%, in comparison with 38%, a quantity usually cited in literature and based mostly on outdated expertise.

Merchandise that include 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 bought behind pharmacy counters. 

The unwanted effects of phenylephrine embody complications, insomnia, and nervousness. At larger doses, it could actually additionally improve blood strain. 

The overview additionally discovered that unique research used to assist the drug’s effectiveness had been inconclusive at finest and contained potential methodological, statistical, and information 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 a substitute 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. 

Based on 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. Slightly 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 shopper concern,» Diane B. Ginsburg, PhD, the pharmacy follow division affiliate dean for well being care partnerships on the College of Texas, mentioned throughout 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 actual optimistic right here to me is the chance from an academic perspective to indicate customers the truth that there are much more methods to deal with» circumstances that embody congestion.  

Based on the FDA overview, «most customers might merely want instruction on the alternate options, together with the right way to acquire ‘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.» 

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