CVS Pulls Multiple Cold And Cough Treatments From Shelves

WOONSOCKET, RI — CVS Health will remove multiple cold and cough treatments from its shelves after doctors and researchers determined that its active ingredient is ineffective, the Associated Press reported Friday.

The drug store chain said it is only removing the small number of oral decongestants that contain phenylephrine as the only active ingredient, according to the outlet.

A CVS spokeswoman declined to say exactly how many products will be pulled, but told the Associated Press that CVS will still sell "many other oral cough and cold products to meet consumer needs."

CVS Health runs more than 9,000 stores in the United States. Its rival, Walgreens, has not pulled any products to date, according to the Associated Press.

In 2021, medicines with phenylephrine generated nearly $2 billion in sales, according to the United States Food and Drug Administration. However, after a September meeting during which the FDA’s Non-prescription Drug Advisory Committee deemed phenylephrine—a common ingredient in over-the-counter oral decongestants—ineffective, the market quickly began to change.

Oral decongestants work by reducing swelling in blood vessels surrounding the nasal cavity. This committee's decision to remove phenylephrine's "Generally Regarded As Safe and Effective" designation after lab results indicated its oral form almost completely metabolized in the bloodstream before reaching nasal passages.

While these findings are not the final word on the fate of over-the-counter oral decongestants containing the ingredient, they do raise concerns about other commonly used medications with similar GRASE status. If an ingredient such as phenylephrine has no proven effectiveness, are current over-the-counter decongestants containing it little more than harmless placebos?

"This study is critical, yet not surprising, for many reasons," Dr. Danielle Kelvas, MD, told the Associated Press. "You’d be surprised how many medications genuinely don’t work but only seem to make a difference due to the placebo effect… If someone thinks a medication will help, and this can be anything from an antidepressant to a pain pill, then the patient will experience a statistically significant difference in their symptoms."

The results of the phenylephrine study, according to Monica Amin, PharmD, MBAc, a pharmacist with Marley Drug, could have a ripple effect as scrutiny turns to other over-the-counter medications.

"It is important to know that phenylephrine has been called into question multiple times in the past and was approved by the FDA based on studies conducted by pharmaceutical companies rather than from clinical trials," Amin told The Associated Press. "Accordingly, there may be an increased focus on approving new OTC products based on independent clinical trials, rather than potentially conflicted studies conducted by drugmakers themselves."

For peace of mind, Amin said that "it is important to note that phenylephrine was determined to be ineffective, not unsafe."

"Consumers should also know that there is a range of alternative products that are available for temporary relief of congestion symptoms, including intranasal steroids, such as Flonase and Nasacort," she added.

The Associated Press contributed to this report.