U.S. pharmacy chain CVS said Thursday that it will no longer sell some of the most common cold and cough medicines with phenylephrine as the only active ingredient.
After a two-day review last month, the Food and Drug Administration’s (FDA) panel of advisers deemed the common over-the-counter (OTC) ingredient as “not effective as a nasal decongestant.”
Following the panel’s decision, CVS has voluntarily chosen to remove products from its shelves that only contain phenylephrine as an active ingredient. The pharmacy chain stated that “other oral cough and cold products will continue to be offered to meet consumer needs,” reported CBS News.
Phenylephrine is also an ingredient in nasal sprays to treat congestion and drops. However, the FDA panel’s advice only related to decongestants taken orally. Nasal sprays and drops are still considered effective.
“Phenylephrine-containing nasal sprays will not be affected by any possible actions taken for phenylephrine in orally administered products (such as tablets or capsules that contain phenylephrine),” the FDA stated.
In a release last month, the FDA stated that neither its officials nor the committee “raised concerns about safety issues with [the] use of oral phenylephrine at the recommended dose.”
The FDA has yet to make a final determination on removing phenylephrine from the market, a process that may take several months.
“Advisory committees provide independent advice and recommendations to FDA, but the agency makes the final decision,” the agency stated. “FDA will consider the input of this advisory committee, and the evidence, before taking any action on the status of oral phenylephrine.”
Phenylephrine is an active ingredient in a number of popular OTC drugs sold at pharmacies across the United States, such as Sudafed PE Sinus Congestion, Dayquil, Mucinex Sinus-Max, Benadryl Allergy Plus Congestion, Theraflu, and Tylenol Cold+Head.
These medicines may become unavailable if FDA officials follow the recommendation of the advisory panel to pull phenylephrine’s GRASE (generally recognized as safe and effective) designation.
Manufacturers may choose to reformulate medications that include phenylephrine at significant financial cost.
The main problem is that when taken orally, phenylephrine undergoes metabolism in the gut. This significantly diminishes the amount that ultimately enters the bloodstream, leaving only a fraction insufficient to alleviate congestion.
“Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine,” Dr. Mark Dykewicz, an allergy specialist at the Saint Louis University School of Medicine, said last month.
Phenylephrine was substituted for pseudoephedrine as the common ingredient in many OTC decongestants after a 2006 law restricted the latter amid reports of its use in methamphetamine production.
The FDA panel’s decision does not mean phenylephrine is harmful, the agency said.
Nor is it harmful if phenylephrine is contained in other drugs as an additional ingredient, such as in medicines that also contain acetaminophen or ibuprofen, which treat symptoms other than congestion like headaches or muscle aches.
“The presence of phenylephrine in these products does not affect how other active ingredients work to treat those symptoms,” the FDA stated. The agency said consumers should read the drug labels for ingredients and important warnings and directions for use.
Diane Ginsburg from the University of Texas at Austin College of Pharmacy said it’s important for consumers to know that any medicines they currently have at home with phenylephrine will not bring them harm.
“Patients need to know for certain that harm will definitely not come to them,” Ms. Ginsburg said. “That reassurance is going to be absolutely critical.”
Consumers who prefer OTC products with phenylephrine can still use decongestants such as Neo-Synephrine, Nostril, Pretz-D, Rhinall, Tur-Bi-Cal, and Vicks Sinex.
Decongestants with phenylephrine account for roughly $1.8 billion in annual sales, according to the FDA.
It’s advisable to consult a health care professional if you have underlying medical conditions or allergies before trying such relief.
