How to feel better when you have a cold?
FDA advisers rejected common cold medication efficacy
How to get better from colds if common cold medication is ineffective?
In a recent article published by Roll Call, FDA advisers on Tuesday unanimously concluded that oral phenylephrine, the decongestant found in many common cold medications, is ineffective.
A common cold medication Phenylephrine, used in a broad array of over-the-counter medications like Sudafed PE and Dimetapp. The drug brought in nearly $1.8 billion in sales in 2022, according to an FDA briefing document, a number that is likely an undercount. Phenylephrine is different from pseudoephedrine, which is found in common cold medication that are kept behind the pharmacy counter.
The Nonprescription Drugs Advisory Committee voted 16-0 that the common cold medication Phenylephrine was ineffective, clearing the way for the agency to remove the common cold medication Phenylephrine from store shelves following years of studies that show it has no benefit.
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The Consumer Healthcare Products Association defended the common cold medication Phenylephrine in front of the panel, arguing the FDA has repeatedly concluded the ingredient is safe and effective. CHPA also argued that the common cold medication pseudoephedrine is not a sufficient alternative, given the purchase restrictions that prevent its sale on convenience store shelves.
The burdens created from decreased choice and availability of these common cold medication would be placed directly onto consumers, which is why CHPA encourages the panel to consider the real-world experience and needs of consumers for common cold medication when making decisions that will have such broad implications.
Patient representative Jennifer Schwartzott, a member of the committee drug said that the oral dose of the common cold medication Phenylephrine should have been removed from the market a long time ago. She added that the patient community deserves common cold medication that treat their symptoms safely and effectively. The FDA did not respond to a request about timing on a decision to potentially remove the common cold medication Phenylephrine from stores.
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