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CVS said Thursday that it is voluntarily removing certain common cough and cold medications after a Food and Drug Administration (FDA) advisory panel concluded last month that its active ingredient does not work.
“We are voluntarily removing certain oral cough and cold products that contain phenylephrine as the sole active ingredient from CVS Pharmacy stores,” a CVS spokesperson said. “Additional oral cough and cold products will continue to be offered to meet consumer needs.”
The move comes just a month after all 16 members of the FDA’s Nonprescription Drugs Advisory Committee (NDAC) agreed that oral phenylephrine, found in common versions of Sudafed, Mucinex, Vicks, Allegra and Dayquil, did not provide effective relief nasal congestion.
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The FDA clarified that neither the agency nor the committee had raised concerns about safety issues with the use of oral phenylephrine at the recommended dose.
The committee’s purpose is to provide independent advice and recommendations to the FDA, but the government agency makes the final decisions.
A customer looks at a package of Sudafed in a CVS. (Matt Stone/MediaNews Group/Boston Herald via Getty Images / Getty Images)
Although the FDA has not yet made a decision on the product’s effectiveness, CVS has decided to withdraw the products.
A Walgreens spokesperson told FOX Business that it is “closely monitoring the situation and actively working with the Walgreens Office of Clinical Integrity and suppliers on appropriate next steps.”
Representatives for Rite Aid did not immediately respond to FOX Business’ request for comment.
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“We are aware of the FDA Advisory Committee’s position on oral phenylephrine (PE) and will follow FDA’s guidance to ensure that the products we sell comply with all laws and regulations,” the spokesperson continued.
Following the panel discussion, the FDA issued a notice alerting consumers that there are a number of products that can treat symptoms other than constipation. According to the FDA, the committee’s recommendations only referred to orally administered phenylephrine and not to the form of a nasal spray.
A CVS Pharmacy in San Francisco, California. (David Paul Morris/Bloomberg via Getty Images / Getty Images)
While some products contain only phenylephrine, other products contain phenylephrine and another active ingredient, such as acetaminophen or ibuprofen, which treats symptoms such as headaches or muscle pain.
“The presence of phenylephrine in these products does not affect how other active ingredients work to treat these symptoms,” the FDA said in a September news release.
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Given that a variety of different drugs can be sold under the same brand name, “consumers should always read the drug label to determine which ingredients are contained in a drug, as well as important warnings and directions for use,” the agency warned.
If the full agency concludes that oral phenylephrine is not effective, which would be a lengthy process and require public participation, it said it would “work closely with manufacturers to reformulate the products as necessary.” “To ensure the availability of safe and effective products to treat symptoms of colds or allergies.”