Last week, the U.S. pharmacy chain CVS Health announced that it will remove from its shelves certain oral cough and cold products with phenylephrine as the only active ingredient.
As Reuters reports, a panel of advisers to the U.S. health regulator last month refused to back the effectiveness of oral over-the-counter (OTC) medicines made with phenylephrine, which is widely used in cold and cough syrups. The independent advisory committee to the US Food and Drug Administration declared that phenylephrine, a popular ingredient in these medications, is ineffective when taken orally.
As a result, CVS made the decision to remove the over-the-counter allergy and cold medicines from their shelves. “We are removing certain oral cough and cold products that contain phenylephrine as the only active ingredient from CVS Pharmacy stores,” a CVS spokesperson told CNN in a statement. The company will continue to sell other “oral cough and cold products” in order to “meet consumer needs,” the statement continued.
“We are aware of the FDA Advisory Committee’s position on oral phenylephrine (PE) and will follow direction from the FDA to ensure products we sell comply with all laws and regulations,” the statement from CVS said.
In a statement Friday, a Walgreens spokesperson said, “Walgreens follows FDA regulations. We are closely monitoring the situation and actively partnering with the Walgreens Office of Clinical Integrity and suppliers on appropriate next steps.”
While the FDA has found that the ingredient is safe to use, many doctors have questioned phenylephrine’s effectiveness for years. These products generated nearly $1.8 billion in sales last year alone, according to data from the FDA that was presented to the Nonprescription Drugs Advisory Committee during the committee’s two-day meeting in September.
Last month, the advisory committee voted no on the specific question: “Do the current scientific data that were presented support that the monograph dosage of orally administered phenylephrine is effective as a nasal decongestant.”
The FDA told the committee it would take its advice into consideration, although it did not give a timeline. The agency has not issued a final decision regarding phenylephrine and has not asked manufacturers or retail pharmacies to remove products containing the ingredient from store shelves.
The Consumer Healthcare Products Association, which represents makers of over-the-counter medicines and dietary supplements as well as consumer medical devices and opposes a change, previously said in a statement that it was disappointed in the committee’s decision.
The group encouraged the FDA, before it made any regulatory changes, to “be mindful of the totality of the evidence supporting this long-standing OTC ingredient, as well as the significantly negative unintended consequences associated with any potential change in oral PE’s regulatory status.”
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