HEALTH
CVS Stops Selling Oral Decongestants With Phenylephrine After FDA Panel Finds It Ineffective
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CVS will no longer sell over-the-counter cold and allergy medications that contain phenylephrine as the only active ingredient, after the Food and Drug Administration concluded last month that the common decongestant is no more effective than a placebo when taken orally.
“We are aware of the FDA Advisory Committees 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 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,” the pharmacy chain said.
The drug is the most popular oral decongestant in the U.S., found in medications including Benadryl Allergy Plus Congestion and Sudafed PE, generating nearly $1.8 billion in sales last year, according to the FDA.
Phenylephrine is supposed to alleviate nasal congestion, but it doesn’t do the job when taken orally, even at doses well above recommended, according the latest FDA review of more than a dozen studies and trials.
The drug is still effective in its nasal spray form, according to the agency. It is meant to work by temporarily constricting blood vessels, and the data presented at a meeting this week showed that when taken orally, not enough of the active drug reaches its target, referred to as bioavailability.
Phenylephrine took over the market in the early 2000s when pseudoephedrine, the decongestant in Sudafed, was moved behind the pharmacy counter to prevent its use as an ingredient in illegal methamphetamine.
When the drug was originally declared effective, an FDA panel reviewed the data for oral doses between 5 mg and 40 mg across 14 studies. The latest panel noted that 11 of those were sponsored on behalf of a single drug manufacturer. The latest panel also noted that the science has since evolved and that those evaluations used an outdated methodology.
The panel looked at three large, adequately controlled trials conducted after 2007, and determined that the efficacy of PE was not significantly different from that of a placebo.
We have now come to the initial conclusion that orally administered PE is not effective as a nasal decongestant, the advisory panel stated in its report.
If the FDA follows the panel’s recommendation and revokes PE’s status as generally recognized as safe and effective, many common cold and allergy products would disappear from store shelves.
The FDA advisory panel noted that education would be required to remind people that pseudoephedrine is still available to consumers from pharmacists upon request.
TMX contributed to this article.
