Pharmacies across the United States are taking a bold step in response to an advisory committee’s ruling that oral phenylephrine, a common decongestant ingredient, is ineffective in treating congestion. The advisory committee’s recommendation does not apply to nasal sprays and other medications that are not taken orally. Weeks after the committee’s verdict, CVS Health has announced that it will no longer sell oral medication containing phenylephrine as the sole active ingredient. This decision comes amidst growing concerns about the efficacy of such medications. While CVS is voluntarily removing these products from its store shelves, it remains uncertain if other pharmacies will follow suit.
The FDA Advisory Committee’s Position
The advisory panel to the Food and Drug Administration (FDA) unanimously agreed on the ineffectiveness of phenylephrine, marking a significant turning point in the debate surrounding its use in over-the-counter cold medicines. Phenylephrine is a key ingredient in various popular cold and flu remedies, including Dayquil, Mucinex Sinus-Max, Sudafed PE Sinus Congestion, and Theraflu. The committee’s vote now sets the stage for the FDA to consider banning the ingredient altogether. This move would result in the removal of hundreds of products containing phenylephrine from stores.
CVS’s Response
CVS Health, one of the largest pharmacy chains in the United States, is taking a proactive stance in response to the FDA advisory committee’s ruling. The company has decided to remove oral cough and cold products that solely rely on phenylephrine as the active ingredient from its pharmacy stores. By doing so, CVS aims to align with the FDA’s position and comply with all applicable laws and regulations.
A statement from CVS to CBS MoneyWatch said, “We are removing certain oral cough and cold products that contain phenylephrine as the only active ingredient from CVS Pharmacy stores.” However, the company reassured customers that other oral cough and cold products will continue to be available to meet consumer needs.
Pharmacies Monitoring the Situation
While CVS has taken the lead in pulling phenylephrine-containing products, it remains uncertain if other major pharmacies, such as Walgreens, will follow suit. Walgreens has stated that it follows FDA regulations but has not explicitly indicated whether it will discontinue the sale of medications containing phenylephrine. As of the writing of this post, the pharmacy is closely monitoring the situation and working with suppliers to determine the appropriate next steps.
Potential Impact on Medicine Availability
The potential ban on phenylephrine could have significant implications for both consumers and manufacturers. Medicine makers warn that if the FDA orders the removal of phenylephrine, certain versions of popular products like Tylenol, Mucinex, and Benadryl could become temporarily scarce as companies scramble to reformulate their remedies with alternative ingredients.
Such a reformulation process may take time and involve rigorous testing to ensure the efficacy and safety of the new formulations. As a result, consumers may experience delays in accessing their preferred cold and flu medications.
In opposition to the FDA statement, the Consumer Healthcare Products Association said that removing the products from pharmaceutical shelves would have additional “negative unintended consequences” such as forcing consumers to see doctors or pharmacists for symptoms they otherwise could have treated at home.
FDA’s Decision-Making Process
While the FDA generally follows the recommendations of its advisory panels, it does not always do so. The agency will carefully consider the committee’s findings before making a final decision regarding the fate of phenylephrine in over-the-counter cold medicines. This decision-making process may take several months, and the findings could be subject to further debate and contestation.
Stay Healthy, Stay Informed
As the FDA reviews the committee’s findings, the future of phenylephrine in over-the-counter cold medicines remains uncertain. Regardless of the ultimate decision, consumers need to remain informed about ineffective products and potential alternatives, especially amid flu season. With resources such as this, the law offices of Panter, Panter, and Sampedro hope to supply clients, friends, and neighbors with the information they need to be safe and healthy.
Panter, Panter & Sampedro is a leading personal injury law firm dedicated to protecting Florida’s families. For over 30 years, our experienced trial attorneys have worked one-on-one with clients to successfully get the justice, recovery, and compensation they deserve.
Sources:
https://www.healthday.com/health-news/conditions/common-cold-2665225802.html
https://medlineplus.gov/druginfo/meds/a606008.html
https://www.cbsnews.com/news/cvs-cold-medicine-phenylephrine-pulled-from-shelves/#
https://www.chicagobusiness.com/health-pulse/walgreens-holding-pattern-cvs-pulls-oral-phenylephrine
