CVS to withdraw cold medications after FDA scientists say they don’t work

The era of over-the-counter cold medications is coming to an end. Major retail chain CVS announced this month that it would remove certain cold and cough products containing oral phenylephrine from its shelves. The Food and Drug Administration may soon push for the ingredient to be removed en masse from these over-the-counter products, following a recent unanimous endorsement of its ineffectiveness by outside experts.

Phenylephrine is considered a decongestant and can be found in the nasal sprays and oral formulations of many brands of cold and allergy medications, including Sudafed PE. However, for decades, many scientists have argued that oral phenylephrine simply does not 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 case and the consensus has clearly swung in favor of the critics, thanks in part to the extensive clinical studies conducted since then.

Last month, before a meeting of an expert advisory committee convened by the FDA, the agency’s own scientists argued that the ingredient is ineffective for decongestion when taken orally. And although oral phenylephrine is not dangerous, scientists have found little scientific evidence that it should remain classified as a Generally Recognized as Safe and Effective, or GRASE, ingredient. The members of the advisory committee then unanimously agreed with this assessment.

The FDA is not required to follow the lead of its advisory committees, but it rarely disagrees with their recommendations. And it seems CVS saw what was happening. Friday, The Associated Press reported that the company will remove a number of oral decongestants containing phenylephrine as the sole active ingredient.

CVS hasn’t said exactly which products will be removed, although it appears to be a small selection. Other major retailers, like Walgreens, are keep calm For now. And the FDA has yet to make a final decision on the status of oral phenylephrine.

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

Even if the FDA decides to remove the GRASE status of oral phenylephrine in the near future, it could be months or even years before it is widely removed from over-the-counter cough and cold products, according to regulatory experts. saiddepending on the degree of resistance presented by drug manufacturers.