FDA says Benadryl and Sudafed in pharmacy shelves are ineffective.

Phenylephrine Deemed Ineffective: Potential Market Impact

Phenylephrine’s Ubiquitous Presence

Phenylephrine, a commonly used ingredient in various over-the-counter nasal decongestants, is now under scrutiny after a unanimous decision by a Food and Drug Administration (FDA) panel that deems it ineffective. This decision has significant implications for the market as it could lead to the removal or reformulation of many over-the-counter medicines that incorporate phenylephrine.

Unanimous FDA Panel Decision

Phenylephrine is a key active compound found in popular over-the-counter medications such as Benadryl Allergy Plus Congestion, Sudafed PE, and Tylenol Cold and Flu Severe Day & Night. However, the FDA panel’s two-day review concluded that phenylephrine is “not effective” at standard or high doses because it is metabolized in the gut and does not reach the nose to provide relief.

Potential Industry Impact

Phenylephrine is exceptionally prevalent in over-the-counter decongestants, and nearly all nasal decongestants on pharmacy shelves contain it. These medications generated substantial sales, amounting to nearly $1.8 billion last year. The unanimous vote by the 16-member Nonprescription Drug Advisory panel could have a significant impact on the industry, specifically affecting oral formulations of phenylephrine, which represent about one-fifth of the $2.2 billion market for oral decongestants.

Implications for Manufacturers

Should the FDA decide to withdraw its Generally Recognized as Safe and Effective (GRASE) designation for oral phenylephrine, companies like Bayer and Johnson and Johnson may be compelled to reformulate their products. Phenylephrine, initially approved by the FDA in the 1970s to alleviate nasal and sinus congestion by constricting blood vessels in the nose, is now being reevaluated due to concerns regarding its efficacy, particularly when taken orally.

Metabolism and Effectiveness

Phenylephrine’s efficacy is compromised by the way it is metabolized in the body. When ingested orally, only a small fraction enters the bloodstream and reaches the nose. Briefing documents compiled by the FDA highlight deficiencies in the trials conducted in the 1960s and 1970s, including small sample sizes and outdated approval techniques.

Not Affecting Pseudoephedrine

It is important to note that the FDA ruling does not pertain to another common decongestant, pseudoephedrine, which is subject to stricter regulations due to its potential use in the illegal production of methamphetamine. Pseudoephedrine-containing products are often kept behind pharmacy counters.

Effectiveness When Applied Directly

Interestingly, phenylephrine appears to be more effective when applied directly to the nose. A petition by pharmacy professors in 2007 prompted the FDA to assess whether a 10-milligram phenylephrine pill was an effective decongestant. Subsequent studies have raised doubts about its effectiveness, with a 2015 study suggesting that various doses of phenylephrine were “not significantly better than placebo” in relieving nasal congestion.

This FDA panel decision challenges the widespread use of phenylephrine in oral decongestants and may prompt changes in the industry, potentially leading to the withdrawal or reformulation of these products. While phenylephrine’s efficacy remains a topic of debate, the unanimous ruling underscores the need for further research and evaluation of over-the-counter medicines to ensure their safety and effectiveness.

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