CVS recently made headlines by announcing that it will be pulling many popular decongestants from its shelves. The reason behind this decision is the revelation that the active ingredient in these decongestants, phenylephrine, does not actually work. This news comes after an advisory panel to the Food and Drug Administration (FDA) ruled that phenylephrine, when taken orally, is no better than a placebo.
Phenylephrine has been on the market for over half a century and is found in many popular over-the-counter drugs, such as Sudafed PE. These drugs generate $1.8 billion in sales each year. However, modern studies have shown that phenylephrine does not provide any improvement in congestion. Mark Dykewicz, an allergy specialist at the Saint Louis University School of Medicine, stated that well-conducted studies have failed to demonstrate any effectiveness of phenylephrine in relieving congestion.
CVS has decided to remove all items that contain phenylephrine as the sole active ingredient from its shelves. While they will still sell some drugs that contain phenylephrine alongside other active ingredients, it is clear that the FDA is on track to ultimately remove phenylephrine from its list of approved medicines.
The question arises: how could a drug that doesn’t work be sold for more than 50 years? Leslie Hendeles, a consultant to the FDA, explains that federal regulators have historically focused on the safety of over-the-counter drugs rather than their effectiveness. As a result, drugs that may not provide any real benefit have been allowed to remain on the market.
This recent development raises concerns about the regulation and approval process for over-the-counter drugs. It highlights the need for a more rigorous evaluation of the effectiveness of these medications before they are made available to the public. The FDA’s focus on safety is undoubtedly important, but it should not come at the expense of ensuring that these drugs actually work.
While CVS has taken the proactive step of removing phenylephrine-containing products from its shelves, other drug chains have not followed suit. Representatives for Walgreens and Rite Aid have stated that they will abide by any future guidance from the FDA. It remains to be seen whether other retailers will take similar action in light of this new information.
To learn more about the FDA’s decision regarding phenylephrine and the implications for over-the-counter drugs, you can read the full article on Business Insider.
