USA Daily News
Top US news in one place!

USA DN

CVS Announces Discontinuation of Medications Solely Containing Phenylephrine as Active Ingredient

post-title

Заголовок: "CVS Responds to FDA Advisory: Removing Ineffective Phenylephrine-Based Medications from Shelves"

Text: In response to a recent declaration by an independent advisory committee to the US Food and Drug Administration (FDA) stating that phenylephrine, a common ingredient in over-the-counter allergy and cold medicines, is ineffective when taken orally, CVS has taken proactive measures. One month after the committee's announcement, CVS has announced the removal of specific oral cough and cold products containing phenylephrine as the sole active ingredient from its shelves.

A spokesperson for CVS informed CNN in a statement that while certain products are being discontinued, the pharmacy chain will continue to offer other oral cough and cold products to meet consumer needs. The decision aligns with the FDA Advisory Committee's position on oral phenylephrine, and CVS expresses its commitment to complying with all laws and regulations set forth by the FDA.

The move by CVS raises questions about potential actions by other retail pharmacies. CNN reached out to Walgreens, and a spokesperson stated, "Walgreens follows FDA regulations. We are closely monitoring the situation and actively partnering with the Walgreens Office of Clinical Integrity and suppliers on appropriate next steps."

Despite the FDA confirming the safety of phenylephrine, the effectiveness of this ingredient has been under scrutiny by many doctors for years. The products in question accounted for nearly $1.8 billion in sales last year. During the FDA advisory committee's meeting in September, the committee voted against the effectiveness of orally administered phenylephrine as a nasal decongestant.

While the FDA has not issued a final decision on phenylephrine, CVS's proactive stance underscores the importance of consumer health and adherence to evolving scientific insights. As the situation develops, it remains to be seen if other pharmacies will take similar steps and how the FDA will ultimately respond to the advisory committee's findings.

Заголовок: "Industry Opposition Persists: Over-the-Counter Medicine Association Disappointed by FDA Committee's Decision on Phenylephrine"

Text: The Consumer Healthcare Products Association (CHPA), representing manufacturers of over-the-counter medicines, dietary supplements, and consumer medical devices, continues to voice opposition following an advisory committee's recent declaration on the effectiveness of phenylephrine in oral medications. The CHPA, which stands against regulatory changes, expressed disappointment in the committee's decision and urged the FDA to consider the comprehensive evidence supporting the longstanding use of oral phenylephrine (PE).

In a statement, the CHPA emphasized the importance of the FDA being mindful of the totality of evidence supporting the over-the-counter ingredient, highlighting potential negative unintended consequences associated with any regulatory alteration to oral PE's status. Logan Ramsey Tucker, a spokesperson for the CHPA, told CNN that, pending the FDA's determination on the committee's recommendation, oral PE remains categorized as a Category 1 over-the-counter ingredient, recognized as generally safe and effective (GRASE).

The industry's steadfast opposition and the call for a thorough evaluation of evidence underscore the complexity surrounding the potential regulatory changes concerning phenylephrine. As the FDA considers the advisory committee's recommendation, the stance of organizations like the CHPA adds a layer of nuance to the ongoing debate, emphasizing the need for a balanced approach that considers both efficacy and potential consequences. CNN's Jen Christensen contributed to this report.

In summary, the recent developments regarding the effectiveness of phenylephrine in oral medications have sparked a significant response from key stakeholders. The decision by CVS to remove certain over-the-counter cough and cold products containing phenylephrine from its shelves reflects a proactive stance in light of an independent advisory committee's declaration that the ingredient is ineffective when taken orally.

The pharmaceutical industry, represented by the Consumer Healthcare Products Association (CHPA), has expressed disappointment with the committee's decision and continues to oppose regulatory changes. The CHPA emphasizes the importance of the FDA considering the entirety of evidence supporting oral phenylephrine's longstanding use and cautions against potential negative unintended consequences associated with any regulatory alterations.

As the FDA deliberates on the committee's recommendation, oral phenylephrine remains classified as a Category 1 over-the-counter ingredient, recognized as generally safe and effective (GRASE). The ongoing dialogue between industry representatives, regulatory bodies, and pharmacies highlights the complexity of the issue, requiring a delicate balance between ensuring the safety and efficacy of medications and acknowledging potential consequences of regulatory shifts.

The industry's unwavering stance and the call for comprehensive evidence evaluation underscore the need for a nuanced approach in addressing the efficacy of phenylephrine. The outcome of these deliberations will likely shape future regulations and practices within the over-the-counter medication landscape, with implications for both consumers and manufacturers. The situation warrants continued monitoring as stakeholders navigate the path forward in light of evolving scientific insights and regulatory considerations.

News