Phenylephrine: FDA moves to pull popular decongestant from shelves amid effectiveness concerns

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CNN
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The US Meals and Drug Administration introduced a proposal to take away oral phenylephrine – a typical ingredient in lots of in style over-the-counter decongestants – from the market, citing evidence that it doesn’t work.

Phenylephrine, present in merchandise like Sudafed PE, Vicks DayQuil and Mucinex Sinus-Max, has been extensively used as a nasal decongestant for many years. The FDA’s proposal isn’t an instantaneous order; it launches a six-month public remark interval, after which the company will make a last resolution on whether or not to tug it from cabinets.

In a preemptive transfer, CVS stopped selling products with phenylephrine final yr after an FDA advisory committee declared that it was ineffective. Different main pharmacies, together with Walgreens and Ceremony Support, nonetheless inventory merchandise containing the drug for now.

Though phenylephrine obtained FDA approval for over-the-counter use within the Nineteen Seventies, its reputation surged in 2005 after laws moved merchandise that use the same decongestant, pseudoephedrine – which, in massive portions, may also be used to make methamphetamine – behind pharmacy counters.

The security of phenylephrine isn’t a priority, however its effectiveness has been debated for years. In 2007, an FDA advisory panel that reviewed obtainable research deemed that phenylephrine “could also be efficient” as a decongestant, though it really helpful additional analysis.

Since then, a number of massive scientific trials have proven that the drug is ineffective when taken orally. In September 2023, an FDA advisory committee concluded that the proof was clear that phenylephrine is ineffective at its typical oral dosage.

If the FDA in the end decides to ban the ingredient, it can enable producers time to “both reformulate or take away drug merchandise containing oral phenylephrine from the market,” Dr. Theresa Michele, director of the FDA’s Workplace of Nonprescription Medication, mentioned Thursday.

Phenylephrine can be utilized in nasal sprays for congestion aid, however Michele famous that the FDA’s proposal targets solely oral types of the drug.

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The Client Healthcare Merchandise Affiliation, which represents producers of over-the-counter medicines, mentioned it was upset by the FDA’s transfer.

“CHPA maintains its place that no adjustments to the GRASE [generally recognized as safe and effective] standing of oral PE for nasal decongestion are warranted primarily based on information made obtainable for the reason that earlier evaluation in 2007. … PE is the one oral OTC decongestant obtainable with out buy restrictions and is included in quite a few OTC cough and chilly medicines labeled with a decongestant declare,” the affiliation said in an announcement.

“Shoppers want choices for self-care, and freedom of selection for self-care is a core attribute of our nation’s healthcare system. PE ought to stay an obtainable choice for shoppers, as a result of People deserve the choice to decide on the protected and efficient OTC medicines they like and depend on.”

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