BREAKING NEWS: FDA Phases Out Popular Decongestant in Cold Medicines Due to Ineffectiveness.giang

U.S. authorities are preparing to phase out a common decongestant, which is present in hundreds of over-the-counter medications, after coming to the conclusion that it doesn’t truly reduce nasal congestion.

Although phenylephrine is an ingredient in many well-known drugs, including Dayquil and Sudafed, its efficacy has long been questioned by experts. Drug manufacturers will probably be forced to withdraw or reformulate their goods as a result of the Food and Drug Administration’s formal proposal last month to revoke its use in pills and liquid solutions.

It’s a victory for skeptics, such as University of Florida researchers who asked the FDA to reexamine the drug’s use in 2007 and 2015. Customers will probably have to switch to other options, such as an older decongestant that was moved over 20 years ago behind the pharmacy counter.

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Phenylephrine, which is frequently used in combination with other medications to treat colds, flu, fevers, and allergies, will be better off without it, according to doctors.

“People walk into the drugstore today and see 55,000 medicines on the shelf and they pick one that is definitely not going to work,” said Dr. Brian Schroer of the Cleveland Clinic. “You take away that option and it will be easier for them to self-direct toward products that really will help them.”

Last year, government experts unanimously decided that oral phenylephrine drugs had not been proven to reduce congestion, which set the stage for the FDA’s conclusion.

Experts examined a number of recent, sizable studies that showed phenylephrine did not cleanse nasal passages any more effectively than a placebo. They also reexamined research from the 1960s and 1970s that provided evidence for the drug’s original use, but they discovered several errors and dubious information.

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Only oral drugs containing phenylephrine, which generate around $1.8 billion in sales annually in the United States, were covered by the panel’s ruling. Although nasal sprays are far less common, the medication is nevertheless thought to be beneficial in them. When it came to cold and allergy remedies, phenylephrine wasn’t always the best option. Many were first made with pseudoephedrine, a different medication.

However, because pseudoephedrine drugs could be converted to methamphetamine, a 2006 regulation mandated that pharmacies relocate them behind the counter. In order to maintain their products’ availability on shop shelves, companies like Johnson & Johnson and Bayer reformulated several of their products and referred to them as “PE” versions of well-known brand names.

The pseudoephedrine-containing versions of Sudafed, Claritin D, and other medicines are still accessible without a prescription at the pharmacy counter, so customers who still wish to take pills or syrups for relief will likely have to go there. Buyers must have a photo ID.