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Thursday, September 14, 2023

Well-liked OTC Decongestants Don’t Actually Work, FDA Says


Sept. 13, 2023 — America’s hottest oral nasal decongestant, phenylephrine, is just not 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 Typically Acknowledged as Secure and Efficient (GRASE) ought 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 evaluation will take.   

The unanimous vote was according to 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physique to be lower than 1%, in comparison with 38%, a quantity typically cited in literature and primarily based on outdated expertise.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 increased doses, it could actually additionally improve blood strain. 

The evaluation additionally discovered that authentic research used to assist the drug’s effectiveness have 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 choice. 

Based on the FDA’s evaluation, 242 million packages or bottles of phenylephrine merchandise have been bought in 2022, leading to $1.76 billion in gross sales. A bit of over 50 million packages of pseudoephedrine have 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 apply 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 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 secure 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 true 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 evaluation, “most customers could merely want instruction on the alternate options, together with find out how to get hold of ‘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.” 

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