CVS Health is pulling certain oral decongestants from store shelves that contain phenylephrine, an ingredient a US Food and Drug Administration (FDA) panel recently deemed ineffective.
The company told RT in a statement that it is removing a “small number” of oral decongestant products that contain phenylephrine as the only active ingredient from CVS Pharmacy stores but will “continue offering many other oral cough and cold products to meet consumer needs.”
Last month, the 16-member FDA advisory panel voted unanimously against the effectiveness of oral formulations of the ingredient. The committee pointed to clinical trials that have been conducted since the last Nonprescription Drugs Advisory Committee meeting in 2007, asserting the trials demonstrate the ingredient doesn’t work in oral formulations.
“We are aware that a number of excellent treatments are available for the treatment of nasal congestion and, in particular, congestion associated with allergic rhinitis. That stated…a significant amount of money is spent by consumers every year on the purchase of products that contain at least one ingredient [oral phenylephrine] that may not be effective,” the committee said in a briefing document issued ahead of last month’s meeting.
The committee noted at the time that customers could be negatively affected if oral phenylephrine is no longer available but said that “most consumers may simply need instruction on the alternatives, including how to obtain ‘behind-the-counter’ pseudoephedrine or to use alternative treatments,” including intranasal decongestants, intranasal steroids, intranasal antihistamines, or intranasal saline products.
The FDA approved phenylephrine, found in many common decongestants, for over-the-counter use in 1976. No safety issues have been identified in orally administered phenylephrine products.
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