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FDA Advisors Claim Decongestant in Common Cold and Allergy Medicines Lacks Efficacy

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Advisory Panel Declares Ineffectiveness of Common Decongestant in Cold and Allergy Medications

An advisory panel to the Food and Drug Administration (FDA) has unanimously declared that the main ingredient found in many over-the-counter cold and allergy medications does not effectively alleviate nasal congestion. The panel of 16 advisors concluded that oral versions of phenylephrine, a nasal decongestant present in popular drugs like Nyquil, Benadryl, Sudafed, and Mucinex, are ineffective in relieving a stuffy nose. While the FDA typically follows the advice of its advisory committees, it is not obligated to do so. However, the agency may initiate a process to remove phenylephrine from the market, leading manufacturers to reformulate widely used cough and cold medications. This potential action could impact companies like Procter & Gamble, the manufacturer of Nyquil, and Kenvue, a Johnson & Johnson spinoff producing Tylenol and Benadryl products. Sales of drugs containing phenylephrine amounted to $1.8 billion last year.

Possible Implications and Consumer Impact

If cough and cold pills containing phenylephrine are pulled from the market, consumers may need to switch to alternative medications or opt for liquid and spray forms of phenylephrine, which were not included in the FDA advisory panel's review. The two-day panel meeting was prompted by researchers at the University of Florida, who petitioned the FDA to remove phenylephrine products based on recent studies demonstrating their failure to outperform placebo pills in patients with congestion from colds and allergies. Despite a previous challenge to the drug's effectiveness in 2007, the FDA allowed the products to remain on the market pending further research. However, FDA staff, in briefing documents released prior to the meeting, concluded that oral phenylephrine formulations do not work effectively even at standard or higher doses. They highlighted that only a minimal amount of the drug reaches the nose to provide congestion relief.

Conclusion: Implications for New Businesses

The advisory panel's declaration about the ineffectiveness of phenylephrine, a common decongestant in cold and allergy medications, could have significant implications for new businesses in the pharmaceutical industry. If the FDA decides to remove phenylephrine from the market, it could lead to a major shift in the industry landscape.

Opportunity for Innovation

This potential change could create opportunities for new businesses to innovate and develop effective alternatives to phenylephrine. It could also open up the market for new entrants, particularly those focusing on natural or non-traditional remedies for cold and allergy symptoms.

Consumer Trust and Expectations

New businesses must also consider the impact on consumer trust. The revelation that a commonly used ingredient is ineffective could lead to increased consumer skepticism. Therefore, new businesses will need to prioritize transparency and evidence-based claims about their products' effectiveness. In conclusion, while the advisory panel's declaration presents challenges, it also opens up opportunities for new businesses in the pharmaceutical industry. By focusing on innovation, evidence-based claims, and transparency, new businesses can navigate this shift and potentially emerge as leaders in the cold and allergy medication market.
Story First Published at: https://www.cnbc.com/2023/09/12/decongestant-phenylephrine-ineffective.html
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