CVS to Pull Cold Medicines After FDA Scientists Say They Don’t Work

The era of a common over-the-counter cold medicine is coming to an end. Major retail chain CVS said this month that it will be pulling some cold and cough products made with oral phenylephrine from its shelves. The Food and Drug Administration may soon push for the ingredient to be removed en masse from these OTC products, following a recent unanimous endorsement of its ineffectiveness by outside experts.

Phenylephrine is considered a decongestant and can be found in nasal spray and oral formulations of many cold and allergy medicine brands, including Sudafed PE. For decades, however, many scientists have argued that oral phenylephrine simply doesn’t work as advertised. In 2007, the FDA debated the issue and ultimately decided that oral phenylephrine should remain on the market. But the agency has now reopened the matter and the consensus has firmly swung in the critics’ favor, thanks in part to large clinical studies conducted since then.

Last month, in advance of an advisory committee meeting of experts assembled by the FDA, the agency’s own scientists argued that the ingredient is ineffective for decongestion when taken orally. And though oral phenylephrine isn’t unsafe, the scientists found little scientific evidence that it should remain classified as a “Generally Recognized as Safe and Effective,” or GRASE, ingredient. The advisory committee members went on to unanimously agree with this assessment.

The FDA isn’t obligated to follow the lead of its advisory committees, but it rarely disagrees with their recommendations. And it appears that CVS has seen the writing on the wall. On Friday, the Associated Press reported that the company will remove some number of oral decongestants that contain phenylephrine as the only active ingredient.

CVS hasn’t clarified exactly which products will be taken down, though it appears to be a small selection. Other large retailers, such as Walgreens, are holding steady for the time being. And the FDA hasn’t yet rendered a final decision on the status of oral phenylephrine.

In a statement last month, the agency clarified that nasal spray products containing phenylephrine are not in danger of being pulled from shelves and that there are other OTC oral decongestants that would be still available to the public even if the ingredient is removed. These alternative decongestants contain pseudoephedrine, however, which is now stocked behind pharmacy counters due to a 2005 federal law created to reduce the risk of the ingredient being turned into methamphetamine. It’s likely that oral phenylephrine has remained on the market as long as it has at least in part because pseudoephedrine is harder to access (and sell) over the counter, and consumers may not realize there is a difference between the products.

Even if the FDA does decide to strip the GRASE status of oral phenylephrine in the near future, it may take months to years before it’s widely removed from OTC cough and cold products, regulation experts have said, depending on how much resistance drug manufacturers put up.

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