On Thursday, CVS announced its voluntary decision to withdraw specific over-the-counter oral cough and cold products. This move comes in response to the recent findings by a Food and Drug Administration (FDA) advisory panel, which concluded last month that the active ingredient in these products lacks efficacy.
“We are voluntarily removing certain oral cough and cold products that contain phenylephrine as the only active ingredient from CVS Pharmacy stores,” a CVS spokesperson said. “Other oral cough and cold products will continue to be offered to meet consumer needs.”
“We are aware of the FDA Advisory Committee’s position on oral phenylephrine (PE) and will follow direction from the FDA to ensure products we sell comply with all laws and regulations,” the spokesperson continued.
This action follows closely on the heels of a unanimous decision by all 16 members of the FDA’s Nonprescription Drugs Advisory Committee (NDAC). They concurred just a month ago that oral phenylephrine, a key component in popular versions of Sudafed, Mucinex, Vicks, Allegra, and Dayquil, lacks effectiveness in relieving nasal congestion.
The FDA explicitly clarified that neither the agency nor the committee expressed concerns about the safety of using oral phenylephrine at the recommended dosage. While the committee’s role is to provide independent advice and recommendations to the FDA, the ultimate decisions rest with the government agency.
Despite the FDA not yet reaching a verdict on the product’s efficacy, CVS has chosen to withdraw these products from their shelves.
A spokesperson from Walgreens informed FOX Business that they are vigilantly monitoring the situation and actively collaborating with the Walgreens Office of Clinical Integrity and their suppliers to determine appropriate next steps.
Subsequent to the panel’s discussion, the FDA issued a notice to alert consumers that a variety of products are effective in treating symptoms other than congestion.
It’s worth noting that the committee’s recommendations solely pertain to orally administered phenylephrine and do not encompass the nasal spray form, as per the FDA’s clarification.
Additionally, some products contain not only phenylephrine but also another active ingredient such as acetaminophen or ibuprofen, which serve to address symptoms like headaches or muscle aches.
“The presence of phenylephrine in these products does not affect how other active ingredients work to treat those symptoms,” the FDA said in a September release.
