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FDA Panel Declares Decongestant Phenylephrine Ineffective: Overview and Product Containing Details

FDA advisory board declares that the popular decongestant ingredient phenylephrine is not effective in treating nasal congestion.

A board of advisers convened by the Food and Drug Administration (FDA) has recently concluded that the most commonly used decongestant ingredient on the market is not effective in treating nasal congestion. The group of experts, assembled by the FDA, unanimously voted to declare that phenylephrine, the ingredient in question, is no more effective than a placebo pill.

Phenylephrine can be found in various over-the-counter medications that are designed to target congestion, including popular brands like Sudafed, Allegra, and Dayquil. It became the primary ingredient in these medications after a 2006 law restricted access to pseudoephedrine, an older ingredient that can be used to produce methamphetamine.

The efficacy of orally administered phenylephrine in relieving nasal discomfort has been called into question multiple times in the past, including in 2007. However, the FDA allowed the drugs to remain on store shelves at that time, pending further research. The recent findings may finally prompt the FDA to demand that drugmakers like Johnson & Johnson and Bayer remove these oral medications from the market.

While this outcome could lead to the removal of phenylephrine from the list of federally approved decongestants, consumers are unlikely to see an immediate impact. The panel vote is merely a suggestion and does not have the binding power of an agreement or determination.

Even if the phenylephrine versions of these drugs remain available for some time, previous studies have shown that they offer no discernible benefits beyond what a placebo can provide.

So, what is phenylephrine supposed to do?

Phenylephrine is a decongestant commonly used to relieve nasal pressure and stuffiness associated with colds or allergies. It is believed to work by stimulating alpha-1 adrenergic receptors in the arteries, causing the dilated blood vessels in the nose to shrink. This, in turn, is meant to prevent fluid in the blood vessels from draining into the nasal tissues, thereby relieving congestion. Phenylephrine can also be used to increase blood pressure when administered in a specific manner.

In 2006, phenylephrine became the primary ingredient in over-the-counter decongestants after pseudoephedrine-containing medicines were moved behind the counter due to their association with methamphetamine production.

Many products on the market are formulated to address multiple symptoms, such as cold and flu medications that treat fever, headache, and congestion. The presence of phenylephrine in these products does not affect the efficacy of other ingredients in treating other targeted symptoms.

It is important to note that there are multiple versions of these products available, some containing phenylephrine and others containing the older ingredient pseudoephedrine. Therefore, it is always advisable to check the label for active ingredients.

The main difference between pseudoephedrine and phenylephrine is that the former has been proven effective in addressing congestion when taken orally, while the latter has not been substantiated as a form of treatment.

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