The latest proposal put forward by the Food and Drug Administration, opposes the effectiveness of oral phenylephrine (which is one of the most popular drugs on the shelf and allergic drugs) and is often found in the category of drugs as an active ingredient after many reviews of drugs that have been on the market for years. The safety agency conducted a review of the literature and evidence and found that oral phenylephrine is ineffective in relieving nasal congestion. This assessment, is in line with what was given about a year ago during the penn-berman advisory committee of the FDA.
Phenylephrine is also a common ingredient in many OTC products such as NyQuil, Benadryl, Sudafed, and Mucinex to name a few and is mainly used to help relieve inflammation of the blood vessels in the nasal area. However, research suggests that the level of phenylephrine used at the standard recommended dose is not effective enough for the depression intended to treat ringworm. In fact, many clinical trials have shown that using phenylephrine to block the nose is no better than taking a sugar pill.
Although not a final decision, the FDA’s position paper begins a process that will lead to a ban on the inclusion of phenylephrine in over-the-counter medications. If the final result takes effect, it will force firms including leading brands such as Procter & Gamble, Bayer, J and J Kenvue, to change the formulation of many cold and allergy preparations. It could also have a major impact on the sales of drug chains such as CVS and Walgreens who will sell millions of bottles of phenylephrine containing medication by 2022.
Although the FDA’s decision is not for safety reasons, the consequences of this decision may be felt by consumers and drug manufacturers. The Consumer Healthcare Products Association, which represents over-the-counter drug manufacturers, opposed the phenylephrine ban, saying it would discourage consumers who prefer to take oral decongestants rather than nasal sprays.
Phenylephrine was designated as the primary over-the-counter nasal decongestant in 2006, as pseudoephedrine, a drug with similar effects, was restricted due to potential misuse and production of illegal drugs, such as methamphetamine.
In the event that the FDA may allow this phenylephrine ethanolamine to be classified as an active ingredient, this could change the dynamics of the nasal decongestant market that needs to be adjusted to consumer preferences for other products such as nasal sprays.
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