Pharmacy chain CVS said it is pulling cold medicines that contain phenylephrine as the only active ingredient from its shelves following a government panel's recommendation that deemed the medicine ineffective.
Last month, a Food and Drug Administration panel said cold and flu remedies such as Dayquil, Mucinex, Sudafed PE, Allegra and Benadryl are mainly ineffective. Phenylephrine is still recognized as safe, but without efficacy, the drug can't fulfill the full generally recognized as safe and effective designation, which allows drugmakers to include an ingredient in OTC products without filing an FDA application.
The FDA said that the panel's recommendation is not final, but would "consider the input of this advisory committee, and the evidence, before taking any action on the status of oral phenylephrine."
If the FDA were to agree with the panel, drugmakers like Johnson & Johnson and Bayer could be forced to reformulate their products or remove them from store shelves based on the panel's recommendation.
"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," CVS said in a statement. "We are removing a small number of oral decongestant products that contain phenylephrine as the only active ingredient from CVS Pharmacy stores but will continue offering many other oral cough and cold products to meet consumer needs."
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In response to CVS' announcement, Walgreens did not specify whether it would follow suit.
"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," Walgreens said in a statement.
The drug became the main ingredient in OTC decongestants after medicines with pseudoephedrine were moved behind the pharmacy counter due to the Combat Methamphetamine Epidemic Act of 2005, which aimed to regulate OTC drugs that could be used in manufacturing illegal drugs. This prompted most companies to reformulate away from the older ingredient and use phenylephrine instead to keep their oral products on the shelves.
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