What prompted the move: CVS announced it would pull the medicines off its shelves after the FDA's Nonprescription Drugs Advisory Committee last month unanimously voted "no" on the question of whether there was evidence to support oral phenylephrine as a nasal decongestant.
"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 said in a statement on Thursday.
Sudafed PE Sinus Congestion and Benadryl Allergy Plus Congestion ULTRATABS are two well-known products that contain phenylephrine.
How other companies are responding: Other major pharmacy chains like Walgreens and RiteAid indicated they are in a holding pattern.
The FDA has not ordered products with phenylephrine to be removed, and CVS's decision was voluntary.
"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 to The Hill.
Rite Aid, meanwhile, indicated it would keep products with the ingredient on shelves for now, saying it "is committed to providing convenient access to approved products to address our customers’ healthcare needs."
"Our pharmacists are available to provide guidance to customers on over-the-counter solutions for alleviating symptoms associated with colds and other illnesses," it added.
Good to Know:
- While the ingredient's efficacy has fallen into doubt, phenylephrine is generally believed to be safe when consumed. Data presented to the FDA committee indicated that the bioavailability of phenylephrine products — the proportion that enters the bloodstream — was less than 1 percent, as most of it is metabolized.
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The question surrounding phenylephrine is not a new issue. Going as far back as 2007, FDA experts found that study results were inconsistent, and the design of those trials would not meet current standards.
