CVS Health intends to withdraw a certain type of commonly used nasal decongestant from its shelves following the ruling of an advisory committee to the U.S. Food and Drug Administration earlier this year, stating its lack of effectiveness.
Thank you for reading this post, don't forget to subscribe!The products contain a phenylephrine (PE) oral formulation, which is present in numerous over-the-counter (OTC) medications.
While PE has been utilized as a nasal decongestant for almost a century, experts have raised doubts about its efficacy for years.
The FDA Nonprescription Drugs Advisory Committee unanimously voted in September that PE did not provide better relief for nasal congestion than a placebo at approved OTC doses.
In response, CVS announced that it will be removing products containing only PE as the active ingredient from its store shelves. This means that products like Dayquil, which utilize a combination of active ingredients, will still be available for purchase.
Walgreens Pharmacy, OTC medicine, relief for cough, cold, and flu.
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CVS Health stated, “We are aware of the FDA Advisory Committee’s stance on oral phenylephrine (PE) and will adhere to the FDA’s guidance to ensure that the products we sell are compliant with all laws and regulations. We are removing certain oral cough and cold products from CVS Pharmacy stores that contain phenylephrine as the sole active ingredient. Other oral cough and cold products will continue to be offered to fulfill consumer needs.”
CVS did not reveal specific details about the brands that will be removed.
The FDA told ABC News that it has not yet determined whether it no longer considers PE to be a safe and effective drug and has not issued a removal order for the product. CVS’s decision is voluntary.
“FDA has no further information to provide at this time regarding the timing of any decisions the agency may make following the advisory committee meeting,” stated the federal health agency.
The Consumer Healthcare Products Association (CHPA) informed ABC News that the advisory committee’s recommendation is not legally binding and does not result in a regulatory change.
“FDA is currently reviewing the regulatory status of oral phenylephrine (PE) following the advisory committee meeting that took place in September,” stated the CHPA in a release. “Until the FDA reaches a decision regarding the committee’s recommendation, oral PE will remain a Category 1 OTC ingredient, generally recognized as safe and effective.”
Concerns about PE were first raised in 2007. Since then, evidence has accumulated suggesting that the drug provides minimal or no relief for nasal congestion.
According to experts, this is likely due to the fact that the body metabolizes the drug before it reaches the nasal passages where it is needed to take effect.
It remains unclear whether other major pharmacy chains will follow CVS’s lead.
Walgreens Boots Alliance did not disclose its plans to remove products containing PE from its shelves and stated that it will bring the matter to the attention of the FDA.
A spokesperson from Walgreens told ABC News, “Walgreens adheres to FDA regulations. We are closely monitoring the situation and actively collaborating with the Walgreens Office of Clinical Integrity and suppliers to determine appropriate next steps.”
Other major pharmacy chains, including Albertsons, Costco, and Kroger, did not respond immediately to ABC News’ request for comment. Walmart did not provide an immediate response.
This report includes contributions from ABC News’ Sasha Pejanic and Sonny Salzman.
Source: abcnews.go.com
