A recent proposal put forward by the Food and Drug Administration, contests the efficacy of oral phenylephrine (which is one of the most popular off the shelf cold and allergic drugs) and which is very commonly found in a genus of drugs as an active ingredient even after numerous pharmaceutical revisions has been for years on the market. The safety agency conducted the evaluation of literature and evidence and established that oral phenylephrine does not work in clearing nasal congestion. This evaluation, coincides with the one given over one year ago during the penn-berman advisory committee of the FDA.
Phenylephrine is also a common preparation in many OTC products such as NyQuil, Benadryl, Sudafed, and Mucinex to name a few and is particularly used to help relieve the swelling of blood vessels in the nasal area. However, studies suggest that the level of phenylephrine which is administered via the standard recommended dosage is not effective enough in tensions aimed at treating the nasal passages. Out of fact, numerous clinical trials have shown that using phenylephrine for declogging the nose is no better than taking a sugar pill.
Though it is not the conclusive ruling, the FDA’s position paper embarks a process that will lead to the prohibition of inclusion of phenylephrine in over the counter medications. If the final outcome comes into effect, it will compel firms including leading brands such as Procter & Gamble, Bayer, J and J Kenvue, to change the formulation of numerous cold and allergy preparations. There could also be a major effect on the sales of retail drug chains like CVS and Walgreens which sold millions of bottles of phenylephrine containing medicines in the year 2022.
Albeit the FDA’s ruling is not on the grounds of safety, the implications of this particular decision may be felt by both consumers and the manufacturers producing medicine. The Consumer Healthcare Products Association which represents the manufacturers of the over-the-counter medicines has opposed the ban of phenylephrine stating that it would inconvenience consumers who prefer to take oral decongestants rather than use nasal sprays.
Phenylephrine was positioned as the principal non-prescription medication for nasal congestion relief in 2006, as pseudoephedrine, a drug with similar effects was being restricted due to possible misuse for illicit drug production, like methamphetamine.
In the event that the FDA might allow this phenylephrine ethanolamine to be classified as an active ingredient, this would change the dynamics of the nasal decongestants market requiring the adjustment of the consumers’ tastes to other substances such as nasal sprays.
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