CVS Health is pulling various cough and cold medicines from its shelves after an FDA advisory panel determined the active ingredient doesn't work. Phenylephrine, approved in the 1930s, has long been found in over-the-counter syrups and pills meant to resolve sinus congestion. However, an FDA analysis found the ingredient, though safe to consume, isn't effective as a nasal decongestant when consumed orally. An FDA advisory panel came to the same conclusion last month. Though the FDA has not removed oral phenylephrine from its list of approved over-the-counter ingredients nor issued guidance to drugmakers or retailers, CVS voluntarily pulled products containing oral phenylephrine as the only active ingredient, such as Sudafed PE, the Wall Street Journal reports.
"We are aware of the FDA Advisory Committee's position on oral phenylephrine and will follow direction from the FDA to ensure products we sell comply with all laws and regulations," CVS said, per CNN, adding it will continue to sell "oral cough and cold products" that "meet consumer needs." It could take the FDA "months or years" before it decides how to move forward, per the Journal. The agency is expected to propose an order to remove the ingredient from its list of approved ingredients, to be followed by a period of public comment. If the order goes ahead, phenylephrine could still be sold in other forms, such as in nasal spray products, which doctors say are effective. For oral products, doctors say pseudoephedrine is an effective alternative for decongestion. (More CVS stories.)
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