CVS Health is considering removing a common type of decongestant from shelves after a U.S. Food and Drug Administration advisory committee said it was ineffective earlier this year.
The products contain the oral formulation of phenylephrine (PE), which is found in several over-the-counter (OTC) medications.
Although PE has been used as a decongestant for nearly a century, experts have questioned its effectiveness for years.
The FDA’s Over-the-Counter Drugs Advisory Committee voted unanimously in September that PE did not improve nasal congestion any more than a placebo at the dose administered for over-the-counter use.
In response, CVS said it was removing products in which PE is the only active ingredient from store shelves. This means products like Dayquil, which uses a combination of active ingredients, will remain available for purchase.
Walgreens Pharmacy, Over-the-Counter Medicines, Cough, Cold & Flu Relief.
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“We are aware of the position of the FDA Advisory Committee on Oral Phenylephrine (PE) and will follow FDA guidance to ensure that the products we sell comply with all laws and regulations,” CVS Health said in a statement. “We are removing certain oral cough and cold products that contain phenylephrine as the sole active ingredient from CVS Pharmacy stores. Other oral cough and cold products will continue to be offered to meet consumer needs.”
CVS did not provide details on which brands 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 ordered the product to be removed from shelves. CVS’s decision is voluntary.
“The FDA has no further information to provide at this time regarding the timing of any decisions it may make following the advisory committee meeting,” the federal health agency said.
The Consumer Healthcare Products Association told ABC News the advisory committee’s recommendation is a non-binding decision and not a regulatory change.
“The FDA is currently reviewing the regulatory status of oral phenylephrine (EP) following the September advisory committee meeting,” CHPA said in a statement. “Until the FDA makes a decision on the committee’s recommendation, oral PE remains a Category 1 over-the-counter ingredient, which is generally recognized as safe and effective.”
Concerns were first raised about PE in 2007. Since then, evidence has mounted showing that the drug offers little or no relief from nasal congestion.
Experts believe this is because the body processes the medication before it reaches the nasal passages where it is intended to work.
It’s unclear whether other major retail pharmacy chains will follow in CVS’s footsteps.
Walgreens Boots Alliance has not revealed whether it plans to remove PE-containing products from store shelves and said it will defer to the FDA.
“Walgreens follows FDA regulations. We are closely monitoring the situation and actively collaborating with the Walgreens Office of Clinical Integrity and suppliers on appropriate next steps,” a Walgreens spokesperson told ABC News.
Other major drugstore chains, including Albertsons, Costco and Kroger, immediately responded to ABC News’ request for comment. Walmart did not have a response immediately available.
ABC News’ Sasha Pezenik and Sony Salzman contributed to this report.
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