CVS is removing a number of well-known cough and allergy medications from its shelves.
The company decided to pull these items after a Food and Drug Administration (FDA) committee claimed to have discovered that a primary component in the drugs is “ineffective.”
The FDA’s Non-prescription Drug Advisory Committee (NDAC) held meetings last month to discuss oral phenylephrine, the active ingredient in a number of nasal congestive and oral medications. The ingredient is present in several brands, including Vicks, Allegra, Mucinex, and others.
Some medications’ only active ingredient is phenylephrine. However, the NDAC’s findings only related to orally administered phenylephrine.
“The committee discussed new data on the effectiveness of oral phenylephrine and concluded that the current scientific data do not support that the recommended dosage of orally administered phenylephrine is effective as a nasal decongestant,” reads a briefing on the meeting by the FDA. “However, neither FDA nor the committee raised concerns about safety issues with [the] use of oral phenylephrine at the recommended dose.”
CVS decided to remove the affected products from its store shelves in response to the NDAC determination. At the same time, a spokesperson from the company clarified that it would continue to offer other medications to meet customer demand.
“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,” said a company spokesperson, according to Fox 4 News KDFW.
Other pharmaceutical retailers have taken notice of the NDAC’s findings. A spokesperson for Walgreens told Fox 4 it was working to determine the appropriate next steps.
Meanwhile, the FDA has not officially ruled on oral phenylephrine’s effectiveness. The process of ordering such products removed from shelves would begin with the agency issuing a proposed order to do so. Afterward, the matter would be open for public comment before a final order is issued.
“FDA would then work closely with manufacturers to reformulate products as needed to help ensure availability of safe and effective products to treat symptoms of colds or allergies,” the agency’s briefing reads.
