The Food and Drug Administration (FDA) has proposed that a common ingredient in most oral over-the-counter cold medicines be removed from the market because they are ineffective.
This move moves the FDA one step closer to removing products containing oral phenylephrine from store shelves.
More than a year after the agency's advisory committee reached a similar conclusion, FDA officials said the agency's review of available data indicates that oral phenylephrine is not effective when taken in liquid or tablet form. said it was found to be ineffective as a nasal decongestant. It is still considered effective as a nasal spray.
Oral phenylephrine is now widely used as a single ingredient or in combination with other ingredients to relieve cold and flu symptoms in products such as Tylenol Cold and Flu, Mucinex, and Dayquil. The agency said the presence of phenylephrine does not affect the action of other active ingredients.
“It is the FDA's role to ensure that medicines are safe and effective,” said Patrizia Cavazzoni, director of the agency's drug division. “Based on our review of the available data and on the advice of our advisory committee, we are moving to the next step in the process proposing the removal of phenylephrine because oral phenylephrine is ineffective as a nasal obstructor.”
The FDA said its proposal was not based on safety concerns, so companies could continue to sell oral drugs containing the common ingredients. This proposal is open for public comment. If the authorities make a final decision, the drug will be removed from shelves.
The agency said it would give manufacturers “appropriate time to reformulate medicines containing oral phenylephrine or remove such medicines from the market.”
An FDA advisory committee of independent experts met last year and agreed with FDA staff that there is no scientific evidence to support the claim that phenylephrine is an effective decongestant at standard or higher doses. It was unanimously agreed.
“Consumers spend significant amounts of money each year” purchasing products with ineffective ingredients, FDA officials said in a briefing.
Phenylephrine was added to over-the-counter cold and allergy medicines in 2006 after pseudoephedrine, a more effective nasal decongestant, was moved behind the counter and restricted because it could be used to make methamphetamine. became the main nasal decongestant.
Although the FDA reaffirmed phenylephrine's effectiveness in 2007, FDA staff questioned the quality of these studies at an advisory meeting last year.
The Consumer Health Care Products Association, which represents over-the-counter drug manufacturers and distributors, protested the agency's proposal.
President and CEO Scott Melville argued that consumers need choices and that discontinuing phenylephrine (PE) would be extremely disruptive.
“PE is the only oral OTC nasal decongestant available without purchase restrictions,” Melville said in a statement. “Consumers need self-care options, and self-care freedom is a core attribute of our nation's health care system.”
He added: “Americans have the right to choose the safe and effective over-the-counter medicines they prefer and trust, and PE should remain an available option for consumers.”
