By Berkeley Lovelace Jr. - NBC News
Phenylephrine, the essential chemical in many over-the-counter oral medications in the United States for colds and allergies, is not used to treat nasal congestion, a Food and Drug Administration advisory panel announced.
The announcement, which came after a unanimous vote, declares oral formulations of phenylephrine ineffective.
This will substantially alter the market for over-the-counter allergy and cold medicines, not least because consumers prefer pills to nasal sprays.
[Stones, insects, bats, plastic: this is how "foreign objects" get into our food]
Phenylephrine — found in drugs such as Sudafed PE, Vicks Sinex and Benadryl Allergy Plus Congestion — is one of the most popular oral decongestants in the United States, generatingnearly $1.800 billion in sales last year, according to FDA data.
Sudafed and other common decongestants that contain the ingredient phenylephrine. AP
The drug is marketed to relieve congestion by reducing inflammation of the blood vessels in the nasal passages.
The panel's vote reflects the overwhelming evidence provided by the FDA that, when taken orally, only a tiny fraction of phenylephrine reaches the nose and relieves congestion.
Susan Blalock, a retired professor at the UNC Eshelman School of Pharmacy in North Carolina and an advisory board member, said the evidence is "pretty compelling that this drug is not effective."
Now the FDA must decide whether the drug will continue to be sold without a prescription. If its free sale is banned, drugs containing this ingredient could be removed from shelves, or pharmaceutical companies will have to develop new formulations.
An FDA spokesman declined to say when the agency will make a final decision on this issue, though the federal agency typically follows the recommendations of its advisory committees.
[Government asks Supreme Court to maintain access to abortion pill mifepristone]
"This drug should have been taken off the market a long time ago," said Jennifer Schwartzott, who represents patients in New York. "The patient community requires and deserves medications that treat their symptoms safely and effectively."
FDA Warns of Two Types of Contaminated Eye Drops
Aug. 24, 202300:33
Phenylephrine gained popularity in the early 2000s as a substitute for pseudoephedrine, the decongestant used in Sudafed, whose sale was regulated in 2006 in an attempt to curb its use as an ingredient in dangerous compounds such as methamphetamine.
The data released by the FDA on Tuesday are the result of five studies on the effectiveness of oral phenylephrine, conducted over the past two decades. All concluded that the decongestant was no more effective than a placebo.
The concern about phenylephrine goes beyond its little or no effectiveness: it can have side effects such as headaches, insomnia and nervousness. In high doses it can increase blood pressure.
The panel did not question the effectiveness of nasal sprays containing the ingredient, as they continue to prove to be a temporary relief from nasal congestion.