FDA panel says common over-the-counter decongestant doesn’t work

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A key ingredient in many over-the-counter cold and allergy medications called phenylephrine doesn’t work to get rid of nasal congestion, a Food and Drug Administration advisory panel concluded Tuesday.

The unanimous vote, which specifically declared oral formulations of phenylephrine ineffective, is expected to disrupt the market for OTC cold and allergy remedies, where consumers largely prefer pills over nasal sprays.

Phenylephrine — found in drugs including Sudafed PE, Vicks Sinex and Benadryl Allergy Plus Congestion — is the most popular oral decongestant in the United States, generating almost $1.8 billion in sales last year, according to data presented Monday by FDA officials.

The drug is thought to relieve congestion by reducing the swelling of blood vessels in the nasal passages.

The panel’s vote reflects damning evidence provided by the FDA that found that when phenylephrine is taken orally, a very small amount of the drug actually reaches the nose to relieve congestion.

Susan Blalock, a retired professor at the UNC Eshelman School of Pharmacy in North Carolina and an advisory committee member, said the evidence is "pretty compelling that this medication is not effective. I don’t think additional data are needed to support that conclusion."

The FDA will now need to decide whether to revoke the drug’s OTC designation as “generally recognized as safe and effective.” The designation, typically used for older drugs, allows drugmakers to include an ingredient in OTC products without the need to file an FDA application.

Without the designation, products containing the ingredient may need to be removed from store shelves, or manufacturers may have to develop new formulations. A spokesperson for the FDA declined to say when the agency will make a final decision. The FDA usually sides with its advisory committees.

"This drug and this oral dose should have been removed from the market a long time ago," said Jennifer Schwartzott, a patient representative from New York. "The patient community requires and deserves medications that treat their symptoms safely and effectively and I don’t believe that this medication does."

Phenylephrine gained popularity in the early 2000s as a replacement for pseudoephedrine, the decongestant used in Sudafed, which was moved behind the pharmacy counter in 2006 in an attempt to curb its misuse as an ingredient to make methamphetamine.

During the two-day meeting, FDA scientists presented the results of five studies conducted over the past two decades on the effectiveness of oral phenylephrine. All the studies concluded that the decongestant was no more effective than a placebo.

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