FDA proposes removing ineffective decongestant found in most cold medicine

The Food and Drug Administration (FDA) is proposing to remove from the market a common ingredient found in most oral over-the-counter cold medicines because it doesn’t work.

The move brings FDA one step closer to getting products containing oral phenylephrine pulled from stores.

FDA officials said an agency review of the available data found oral phenylephrine is not effective as a nasal decongestant when taken in liquid or pill form, more than a year after an agency advisory panel came to the same conclusion. It's still considered to be effective in nasal sprays.

Currently, oral phenylephrine is widely used either as a standalone ingredient or in combination with others to ease cold and flu symptoms in products like Tylenol Cold and Flu, Mucinex, and Dayquil. The agency said the presence of phenylephrine doesn’t affect how the other active ingredients work.

“It is the FDA’s role to ensure that drugs are safe and effective,” said Patrizia Cavazzoni, the director of the agency’s drug division. “Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”

FDA said its proposal was not based on safety concerns, so companies can still market oral drugs containing the common ingredient. The proposal is open to public comments. If the agency makes a final decision, then the drugs would have to be removed from shelves.

The agency said it would provide manufacturers with “appropriate time to either reformulate drugs containing oral phenylephrine or remove such drugs from the market.”

An FDA advisory panel of independent experts met last year and unanimously agreed with FDA staff that there was no scientific evidence to support the claim that phenylephrine was an effective decongestant at standard or even higher doses.

In briefing documents, FDA staff said “a significant amount of money is spent by consumers every year” buying a product with an ingredient that doesn’t work.

Phenylephrine became the main decongestant in over-the-counter cold and allergy medicines in 2006, after the more effective decongestant pseudoephedrine was moved behind the counter and restricted, because it could be used to make methamphetamine.

FDA reaffirmed the efficacy of phenylephrine in 2007, but agency staff called into question the quality of those studies during last year’s advisory meeting.

The Consumer Healthcare Products Association, which represents manufacturers and marketers of over-the-counter medicines, protested the agency's proposal.

President and CEO Scott Melville argued consumers need a choice, and pulling phenylephrine (PE) would be immensely disruptive.

“PE is the only oral OTC decongestant available without purchase restrictions,” Melville said in a statement. “Consumers need options for self-care, and freedom of choice for self-care is a core attribute of our nation’s healthcare system."

"PE should remain an available option for consumers, because Americans deserve the option to choose the safe and effective OTC medicines they prefer and rely on," he added.