CVS to recall cold medicine after FDA scientists say it’s ineffective

The days of common over-the-counter cold medicines are coming to an end. Major retail chain CVS said this month it would pull some cold and cough products made with oral phenylephrine from its shelves. The U.S. Food and Drug Administration may soon push to largely remove the ingredient from these over-the-counter products after outside experts recently unanimously agreed that the ingredient is ineffective.

Phenylephrine is considered a decongestant and can be found in nasal spray and oral formulations of many brands of cold and allergy medications, including Sudafed PE. . However, for decades, many scientists have believed that oral phenylephrine simply wasn’t as effective 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 revisited the matter, and consensus has swung in favor of the criticism, thanks in part to large clinical studies conducted since then.

Last month, ahead of the FDA’s expert advisory committee meeting, the agency’s own scientists debate This ingredient is not effective in relieving congestion when taken orally. Although oral phenylephrine is not unsafe, scientists found little scientific evidence that it should continue to be classified as a “generally recognized as safe and effective” or GRASE ingredient. Advisory Committee members continue to unanimously agree with this assessment.

The FDA is not required to follow the lead of its advisory committees, but rarely disagrees with their recommendations. It seems CVS has seen the writing on the wall.Friday, The Associated Press report The company will phase out some oral decongestants that contain phenylephrine as the only active ingredient.

CVS has not yet specified which products will be recalled, although it appears to be a small number of products. Other large retailers such as Walgreens stand firm At this time, the FDA has not made 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 the shelves, and that even if the ingredient is removed from the shelves, other over-the-counter oral decongestants will still be available to the public. However, these alternative decongestants contain pseudoephedrine.Now stored behind pharmacy counters under 2005 federal law Created to reduce the risk of ingredients converting to methamphetamine. Oral phenylephrine has likely remained on the market, at least in part, because pseudoephedrine is more difficult to obtain (and sell) without a prescription, and consumers may not be aware of the differences between these products.

Regulatory experts say that even if the FDA decides to remove oral phenylephrine’s GRASE status in the near future, it could take months or years before it is widely removed from over-the-counter cough and cold products. I saiddepending on how resistant drugmakers are.