CVS is voluntarily removing over-the-counter cough and cold products from its shelves after a Food and Drug Administration advisory panel confirmed the active ingredients of America’s leading decongestive “medicines” do not work.
Millions who consume Dayquil, Sudafed, and other medications stocked on store shelves while looking for relief from a stuffy nose might as well be taking dummy pills, according to government experts who reviewed the latest research on the long-questioned drug ingredients.
Last month, 16 members of the FDA’s Nonprescription Drug Advisory Committee unanimously voted against the effectiveness of oral phenylephrine, the key ingredient contained in Sudafed, Mucinex, Allegra, Dayquill and all the highest-selling decongestants included on a federal list of medicines deemed effective for over-the-counter pills and liquids.
Phenylephrine is also found in Tylenol for Cold and Flu Severe Day & Night.
The products are safe but do nothing to alleviate nasal congestion, the panel determined.
A CVS spokesperson announced Thursday that the products containing phenylephrine are no longer available in stores nationwide.
“We are voluntarily removing certain oral cough and cold products that contain phenylephrine as the only active ingredient from CVS Pharmacy stores,” a CVS spokesperson announced Thursday. “Other oral cough and cold products will continue to be offered to meet consumer needs.
“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 FDA hasn’t made any decision regarding the product’s effectiveness or distribution amid CVS’s decision to pull the products.
Instead, the agency encourages consumers to read the labels and make up their own minds about the drug’s effectiveness.
“Consumers should always read the drug fact label to determine which ingredients are in a medication, as well as important warnings and directions for use,” the agency said. “Work closely with manufacturers to reformulate products as needed to help ensure availability of safe and effective products to treat symptoms of colds or allergies.”
If the FDA complies with its advisory panel’s recommendations, Johnson & Johnson, Bayer and other drugmakers would be required to pull their oral medications containing phenylephrine from store shelves, a move that would force consumers to switch to the behind-the-counter pseudoephedrine products or to phenylephrine-based nasal sprays and drops.
With only the drops and nasal sprays available, the FDA would have to work with drugstores, pharmacists and other health providers to educate consumers about the remaining options for treating congestion, warns the panel of government advisors
Studying phenylephrine at higher doses is not an option because it can push blood pressure to potentially dangerous levels, the committee told the FDA.
The common cold “medicines” remain on shelves at Walgreens and Rite Aid.
Executives at Walgreens are “closely monitoring the situation and actively partnering with the Walgreens Office of Clinical Integrity and suppliers on appropriate next steps,” a spokesperson for the pharmacy retail giant told FOX Business.
The FDA assembled its outside advisers to examine phenylephrine after researchers at the University of Florida petitioned the FDA to remove nearly all phenylephrine products based on numerous recent studies indicating they failed to outperform placebo pills in patients with cold and allergy congestion.
