(CNN) CVS is removing some over-the-counter allergy and cold medications from its shelves, a month after an independent advisory panel to the U.S. Food and Drug Administration said phenylephrine, a popular ingredient in these medications, is ineffective when taken orally.
We are removing certain oral cough and cold products that contain phenylephrine as the sole active ingredient from CVS Pharmacy stores, a CVS spokesperson told CNN in a statement Thursday.
The company will continue to sell other oral cough and cold products to meet consumer needs, the release continued.
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, the CVS release said.
CNN reached out to other retail pharmacies to see if they were considering taking similar steps. In a statement Friday, a Walgreens spokesperson told CNN that Walgreens complies with FDA regulations. We are closely monitoring the situation and actively collaborating with the Walgreens Office of Clinical Integrity and suppliers on appropriate next steps.
Although the FDA has found the ingredient safe to use, many doctors have questioned the effectiveness of phenylephrines for years. These products generated nearly $1.8 billion in sales last year alone, according to FDA data that was presented to the Nonprescription Drug Advisory Committee during the committee’s two-day meeting in September.
Last month, the advisory committee voted no on the specific question: Does the current scientific data presented support that the monograph dose of phenylephrine administered orally is effective as a nasal decongestant.
The FDA told the committee it would consider its advice, although it did not give a timeline. The agency has not made a final decision regarding phenylephrine and has not directed manufacturers or retail pharmacies to remove products containing this ingredient from store shelves.
The Consumer Healthcare Products Association, which represents manufacturers of over-the-counter drugs and dietary supplements as well as consumer medical devices and which opposes a change, previously said in a statement that it was disappointed by the decision. committee.
The panel encouraged the FDA, before making regulatory changes, to be aware of the full body of evidence supporting this long-standing OTC ingredient, as well as the significant negative unintended consequences associated with any potential change in the regulatory status of oral EDs .
A CHPA spokesperson, Logan Ramsey Tucker, told CNN in a statement Thursday: 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 (GRASE).
CNN’s Jen Christensen contributed to this report.
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