CVS is voluntarily pulling from its shelves some common decongestants that contain an active ingredient FDA advisors have deemed ineffective at relieving congestion.
The pharmacy retail giant confirmed to major news outlets on Oct. 19 that over-the-counter cold and flu medicines with phenylephrine as the only active ingredient will be pulled from its shelves and no longer be available for sale. The move comes about a month after an FDA advisory committee concluded oral formulations of phenylephrine are not effective at relieving congestion.
The ingredient was approved for nasal congestion in 1976, but over the years, data has shown it does not help relieve symptoms when taken orally. Days after the advisory committee's determination, the FDA clarified it has not yet made a final decision on the matter.
A CVS spokesperson told The Wall Street Journal other oral cough and cold products will remain available to customers, adding that the company is aware of the advisory panel's position and will follow direction from the FDA to ensure products sold comply with laws and regulations. No other retail pharmacy chain has taken voluntary action yet. Walgreens told WSJ it is "closely monitoring the situation" and a Walmart spokesperson declined to comment.
If the FDA does determine oral phenylephrine is not effective, it would propose an order to revoke its current classification as "generally recognized as safe and effective." The public would then be invited to comment on the matter and the FDA would issue a final order after considering public comments.
"FDA would then work closely with manufacturers to reformulate products as needed to help ensure the availability of safe and effective products to treat symptoms of colds or allergies," the agency has said. That process could ultimately take years.