CVS is taking off its shelves cold medicines that contain a decongestant that a Food and Drug Administration panel says doesn’t work.
The pharmacy chain’s decision is voluntary, as the FDA’s findings were made by an advisory panel and are not legally binding.
Oral medicines that contain phenylephrine as the sole active ingredient are being removed, a CVS spokesperson told the Wall Street Journal Thursday. The decision is voluntary, as the findings by the FDA advisory panel are not legally binding.
Competitor Walgreens is waiting on further guidance from the FDA regarding phenylephrine before making a decision on the products, according to a Q&A page on their website.
“Walgreens follows guidance from regulatory agencies such as the FDA … there is no formal recommendation for retailers to stop selling or consumers to stop using phenylephrine,” Walgreens wrote.
While the FDA panel found that phenylephrine products are safe, it also found that the products are not actually working to stop congestion from colds and other ailments. The findings do not apply to nasal sprays containing phenylephrine.
“The committee discussed new data on the effectiveness of oral phenylephrine and concluded that the current scientific data do not support that the recommended dosage of orally administered phenylephrine is effective as a nasal decongestant,” the FDA wrote in a Sept. 14 release.
The FDA has not recalled drugs containing phenylephrine, but the panel’s findings do clear the way for the agency to remove phenylephrine from a list of approved ingredients, first as a proposed order and then as a final rule following a public comment period.
If the FDA goes through that process and determines that phenylephrine does not work, products containing it, whether as a sole ingredient or as one of multiple active ingredients, would no longer be legal for sale in the U.S.
Industry groups disagree with the panel’s findings.
“We are disappointed by the outcome of today’s FDA Advisory Committee meeting because its non-binding recommendation is at odds with the numerous clinical trials and previous regulatory determinations affirming oral [phenylephrine] as a safe and effective decongestant at its labeled dose,” the Consumer Healthcare Products Association said in September.
