Fashionable OTC Decongestants Don’t Actually Work, FDA Says

Sept. 13, 2023 — America’s hottest oral nasal decongestant, phenylephrine, will not be efficient and no higher than a placebo, an FDA panel mentioned Tuesday. 

The unanimous vote  of the Nonprescription Drug Advisory Committee was in step with a overview of pharmacology and scientific 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physique to be lower than 1%, in comparison with 38%, a quantity typically cited in literature and primarily based on outdated know-how.

Merchandise that include phenylephrine embrace 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 embrace these offered behind pharmacy counters.  The uncomfortable side effects of phenylephrine embrace complications, insomnia, and nervousness. At larger doses, it may well additionally enhance 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) 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 overview will take.   

The overview additionally discovered that authentic research used to assist the drug’s effectiveness have been inconclusive at greatest 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 as a result 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 possibility. 

In line with the FDA’s overview, 242 million packages or bottles of phenylephrine merchandise have been offered in 2022, leading to $1.76 billion in gross sales. Somewhat over 50 million packages of pseudoephedrine have been offered that very same 12 months, leading to $542 million in gross sales.

“I believe 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, 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 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 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 embrace congestion.  

In line with the FDA overview, “most shoppers could merely want instruction on the options, together with how one can 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.” 

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