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FDA Panel Deems Popular Nasal Decongestant Ineffective, May Impact OTC Medication Market

Unanimous Decision Raises Questions About Phenylephrine’s Efficacy

By Dolores Quintana

A unanimous decision by a Food and Drug Administration (FDA) advisory panel on Tuesday has cast doubt on the effectiveness of phenylephrine, a key ingredient in numerous over-the-counter cold and allergy medications, in alleviating nasal congestion. This is a conclusion that many people who suffer from sinus issues came to long ago. Phenylephrine, used in Sudafed PE, was a substitute for Pseudoephedrine, which has a common illegal and alternative use as an ingredient in the production of methamphetamine. Medicines that contain Pseudoephedrine were removed from over-the-counter sales in 2006. 

The panel’s vote, which specifically addressed the ineffectiveness of oral formulations of phenylephrine, is poised to disrupt the market for over-the-counter (OTC) cold and allergy remedies. These remedies, which predominantly rely on pill forms, are preferred by consumers. Phenylephrine is a common component in medications such as Sudafed PE, Vicks Nyquil Sinex Nighttime Sinus Relief, and Benadryl Allergy Plus Congestion. It stands as the most widely used oral decongestant in the United States, generating nearly $1.8 billion in sales in the previous year, as reported by FDA officials on Monday.

The panel’s vote aligns with the FDA’s comprehensive findings, which indicated that when taken orally, only a minute amount of phenylephrine actually reaches the nasal area to provide congestion relief.

Susan Blalock, an advisory committee member and retired professor at the UNC Eshelman School of Pharmacy in North Carolina, stated, “The evidence is quite compelling that this medication is ineffective. I believe no further data are necessary to support this conclusion.” The FDA must now determine whether to withdraw phenylephrine’s over-the-counter designation as “generally recognized as safe and effective.” This designation typically applied to older drugs, permits the inclusion of an ingredient in OTC products without requiring an FDA application.

Should the designation be revoked, products containing phenylephrine may be removed from store shelves, or manufacturers may need to develop alternative formulations. An FDA spokesperson declined to specify when the agency will make a final decision, though historically, the FDA tends to align with its advisory committees.
Jennifer Schwartzott, a patient representative from New York, commented, “This drug and its oral form should have been removed from the market long ago. The patient community requires and deserves medications that safely and effectively address their symptoms, and I do not believe this medication fulfills that need.”

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