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FDA Moves to Remove Ineffective Decongestant in Cold and Cough Medications • Hollywood Unlocked

rmtsa by rmtsa
December 24, 2024
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FDA Moves to Remove Ineffective Decongestant in Cold and Cough Medications • Hollywood Unlocked
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The Food and Drug Administration announced plans to phase out phenylephrine, a decongestant found in several over-the-counter medications after research indicated it does not relieve nasal congestion.

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Last month, the agency officially proposed revoking the use of phenylephrine in pills and liquid solutions. This decision will likely require drug manufacturers to remove or reformulate hundreds of products containing this ingredient. According to the Associated Press, the proposal comes after years of skepticism from experts. Researchers at the University of Florida even petitioned the FDA back in 2007 to review the drug’s effectiveness. Recent studies have shown that phenylephrine is no more effective than a placebo in relieving nasal congestion.

Experts explained that the decongestant, when taken orally, is quickly broken down in the stomach, making it ineffective. While nasal sprays containing phenylephrine remain effective, they are far less popular than pill-based solutions. This change will mean switching to alternatives such as the older decongestant pseudoephedrine, which was moved behind pharmacy counters in 2006 due to its potential misuse in methamphetamine production, remains available.

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Medications like Sudafed and Claritin-D containing pseudoephedrine can still be purchased without a prescription but require showing a photo ID. For longer-term congestion management, doctors recommend nasal steroids like Flonase, Nasacort, and Rhinocort. While these treatments need daily use to be effective, they are considered the gold standard for combating stuffiness and seasonal allergies.

The FDA has to follow a public process to remove oral phenylephrine from its approved drug list, including a six-month comment period and further reviews. For now, phenylephrine-based medications remain on shelves, but experts warn against relying on them



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