CVS Health is planning to remove one type of a common decongestant from shelves after an advisory committee to the U.S. Food and Drug Administration discussed it was ineffective earlier this one year.
The products contain the oral means of phenylephrine (PE), which is positioned in a lot of over-the-counter (OTC) medicine.
Although PE has been used as a decongestant for nearly a century, pros had been questioning its efficacy for years.
The FDA Nonprescription Drugs Advisory Committee unanimously voted in September that PE didn’t give a boost to nasal congestion to any extent further than a placebo at the dosage given for OTC use.
In response, CVS discussed it’s removing products, through which PE is the only vigorous facet from store shelves. This method products like Dayquil, which used a mix of vigorous parts, will keep in the stores.
Walgreens pharmacy, over-the-counter medicine, cough, cold and flu aid.
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“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 Health discussed in a commentary. “We are removing certain oral cough and cold products that contain phenylephrine as the only active ingredient from CVS Pharmacy stores. Other oral cough and cold products will continue to be offered to meet consumer needs.”
CVS didn’t give specifies on producers that may be removed.
The FDA urged ABC News it has now not however determined whether or not or no longer it no longer considers PE to be a safe and environment friendly medicine and has now not ordered the product to be removed from shelves. CVS’s switch is voluntary.
“The FDA has no further information to provide at this time regarding the timing of any decision the agency may make following the advisory committee meeting,” the federal neatly being corporate discussed.
The Consumer Healthcare Products Association urged ABC News that the advisory committee’s recommendation is a non-binding solution and now not a change in law.
“FDA is currently in the process of reviewing the regulatory status of oral phenylephrine (PE) following September’s advisory committee meeting,” CHPA discussed in a commentary. “Until FDA makes a determination on the committee’s recommendation, oral PE remains a Category 1 OTC ingredient, which is generally recognized as safe and effective.”
Concerns had been first raised about PE in 2007. Since then, evidence has accumulated showing that the drug supplies little to no aid for nasal congestion.
Experts believe it’s for the reason that body processes the drug previous to it reaches the nasal passages where it should art work.
It’s unclear if other number one retail pharmacy chains will observe in CVS’s footsteps.
Walgreens Boots Alliance would now not disclose whether or not or no longer it was planning to remove products with PE from store shelves and discussed it’ll defer to the FDA.
“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,” a Walgreens spokesperson urged ABC News.
Other number one pharmacy chains in conjunction with Albertsons, Costco and Kroger did in an instant reply to ABC News’ request for observation. Walmart didn’t have an answer in an instant available.
ABC News’ Sasha Pezenik and Sony Salzman contributed to this report.
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