June 13, 2024

An FDA medical advisory panel that phenylephrine (PE), a key ingredient in lots of over-the-counter chilly drugs, doesn’t truly work to deal with nasal congestion when taken orally on the advisable 10 mg dose each 4 hours. Phenylephrine was final evaluated for over-the-counter use as an oral and intranasal decongestant in 1976, in line with the panel. In case you’re protecting rating at dwelling, which means lots of the OTC decongestants customers within the US have been shopping for for almost the final 50 years had been, in line with the FDA, “failed to supply any profit over [a] placebo.”

This willpower will influence drug makers that use PE as an lively ingredient, which will be present in , Vicks Sinex, and Benadryl Allergy Plus Congestion, for instance.

As a part of the panel’s overview, the FDA reported that in 2022, an estimated 242 million packages of OTC cough and allergy oral merchandise containing PE had been offered in retail shops, which raked in about $1.8 billion in gross sales. It even notes that the true extent of use of PE-containing chilly merchandise is probably going underestimated as a result of retail gross sales knowledge doesn’t “seize gross sales exercise from Costco, comfort shops, specialty shops, web gross sales, telephone gross sales, or kiosks.”

The FDA will now want to find out if it can revoke PE’s oral OTC designation as “protected and efficient.” With out that designation, drug makers may even see their merchandise faraway from shops.

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