CVS is pulling popular cough and cold products with phenylephrine as the only active ingredient from shelves.
The pharmacy chain is voluntarily removing the products after a US Food and Drug Administration advisory panel last month refused to review the effectiveness of oral over-the-counter (OTC) medicines made with the ingredient, which is commonly used in cold and cough syrups. to support. .
The US Food and Drug Administration (FDA) has not yet removed phenylephrine from its list of ingredients for over-the-counter use and plans to consult public opinion before making a decision.
“Additional cough and cold products will be offered to meet consumer needs,” CVS said.
CVS will begin removing popular cough and cold products that contain phenylephrine as the only active ingredient from shelves. Pictured: Empty CVS shelves in New York today
The drugstore chain is voluntarily removing the products after a US Food and Drug Administration advisory panel last month refused to support the effectiveness of oral, over-the-counter medications containing the ingredient
Rival drugstore chain Walgreens said Thursday it would follow FDA regulations and monitor the situation.
Benadryl, Kenvue’s Tylenol, and GSK’s Advil are some of the best-known cough and cold syrups that contain phenylephrine and are sold in the United States.
The FDA announced it will consider removing phenylephrine from medications after a panel of outside experts unanimously ruled that the ingredient, commonly used in cold and cough syrups, is ineffective.
If the FDA agrees with the panel’s position, it will propose removing phenylephrine from the list of ingredients approved in over-the-counter drugs and seek public comment on the proposal.
If the FDA, after reviewing public comments, still believes that phenylephrine doesn’t work, it will issue a final order and work with manufacturers to reformulate products to effectively treat cold or allergy symptoms.
The FDA has not indicated how it will assess public opinion. DailyMail.com has contacted the agency for clarification.
The ingredient is protected by the FDA’s GRASE (Generally Recognized as Safe and Effective) designation, but a withdrawal of the approval could require manufacturers such as Bayer, Johnson and Johnson to reformulate the formula.
Phenylephrine is ubiquitous, so much so that almost every nasal decongestant on pharmacy shelves contains it.
Drugs containing it generated nearly $1.8 billion in sales last year, according to FDA officials.
Phenylephrine is ubiquitous, so much so that almost every nasal decongestant on pharmacy shelves contains it
A unanimous vote by the 16-member OTC Drug Advisory Council could be a major blow to the industry.
The FDA’s decision applies only to oral formulations of phenylephrine.
If the agency decides to revoke the GRASE label for oral phenylephrine, major manufacturers of drugs like Sudafed PE and Benadryl could be forced to reformulate them.
Phenylephrine was approved by the FDA in the 1970s to shrink dilated blood vessels in the nose, thereby relieving nasal and sinus congestion.
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However, there has since been further research questioning whether oral formulations of the drug offer any measurable benefit given the way it is metabolized in the body.
The drug is metabolized in the gut, with only some entering the bloodstream and reaching the nose.
In fact, information documents compiled by the FDA show that a concentration of less than one percent of the drug can enter the nose after it breaks down in the intestines.
The documents detail shortcomings in studies of the ingredient in the 1960s and 1970s, which relied on small sample sizes and used drug approval techniques that are no longer used by the FDA.
The unanimous decision does not include another popular decongestant, pseudoephedrine.
In 2006, a law was passed that restricted access to pseudoephedrine, the active ingredient in many versions of Sudafed, by placing it behind pharmacy counters.
The ingredient is used to illegally process methamphetamine.
The original Sudafed, which contains pseudoephedrine, is less popular than versions that do not require a visit to the pharmacy, and American consumers overwhelmingly prefer pills to nasal sprays.
Phenylephrine seems to work better when applied directly to the nose.
In 2007, pharmacy professors at the University of Florida filed a petition asking the FDA to investigate whether a 10-milligram phenylephrine pill has a decongestant effect.
In a meta-analysis of the available data, they said: “The results of the studies published after the 2007 advisory committee meeting clearly show this.” [phenylephrine ] is no more effective than placebo in reducing nasal congestion and quadrupling the dose provided no additional benefit.”
Since then, a number of studies have emerged suggesting its ineffectiveness.
In 2015, a study sponsored in part by the New Jersey-based pharmaceutical company Merck & Co found that the 10-milligram dose and 20-, 30-, or 40-milligram doses “were not significantly better than placebo in relieving not constipation.” . Nose’. ‘ in a sample of 539 adults.
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Crystal Leahy is an author and health journalist who writes for The Fashion Vibes. With a background in health and wellness, Crystal has a passion for helping people live their best lives through healthy habits and lifestyles.
