ATLANTA — The Food and Drug Administration says it wants to remove some of the most popular over-the-counter decongestants that have a common ingredient in them.
The FDA said there’s evidence that phenylephrine doesn’t work. Brand names like Sudafed, DayQuil and others contain the ingredient.
“It is the FDA’s role to ensure that drugs are safe and effective,” Patrizia Cavazzoni, M.D., the director of the FDA’s Center for Drug Evaluation and Research, said. “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.”
The effectiveness of phenylephrine has been debated for years.
An FDA advisory panel in 2007 said it “may be effective” as a decongestant.
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Since then, a number of large clinical trials have concluded it’s not effective when taken orally. However, the drug’s safety is not a concern.
“Consumers should know that a range of safe and effective drugs and other treatments is available to temporarily relieve congestion symptoms due to allergies or a common cold,” said Theresa Michele, M.D., the FDA director of the Office of Nonprescription Drug Products. “Consumers can also talk to their doctor or pharmacist about ways to treat these symptoms.”
The FDA proposal now kicks off a six-month public comment period.
The agency would then make a final decision on whether to pull the drug from store shelves.
Major retailers like CVS have already pulled products containing phenylephrine. Nasal sprays that include the ingredient have not been included in the FDA’s proposal.