The Food and Drug Administration proposed eliminating the use of oral phenylephrine, a common ingredient in over-the-counter cold and allergy medications. According to a report by NBC News, the agency said a comprehensive review of available data showed that the ingredient does not actually relieve nasal congestion.

This comes after more than a year of advisors fda Reached the same conclusion unanimously. Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a release that based on the data, “we are taking this next step in the process of proposing removal of oral phenylephrine as a nasal decongestant.” Is not effective.”

The agency said the order is not based on safety concerns and is not yet final, meaning companies can still market over-the-counter medications containing oral phenylephrine. However, a final decision would force pharmacies to clear the shelves of hundreds of products containing oral forms of the ingredient, which are found in versions of drugs such as NyQuil, Benadryl, Sudafed and Mucinex.

An NBC News report said the final order would require drugmakers like Procter & Gamble, Bayer and Johnson & Johnson’s spinoff Kenview to reformulate many of their oral cold and allergy products. Phenylephrine is thought to relieve congestion by reducing the swelling of blood vessels in the nasal passages. Without oral phenylephrine on the market, patients will likely struggle to find spray versions of the drug, or other drugs with different ingredients, both of which are not affected by the FDA’s decision.

Last year’s meeting of FDA advisors was organized by University of Florida researchers who petitioned the agency to remove phenylephrine products from the market based on studies that showed they were as effective as placebo pills in patients with colds and allergies. Had failed to perform better than. Researchers also challenged the drug’s effectiveness in 2007. However, the FDA allowed the products to remain on the market pending additional research.

Representatives from the Consumer Healthcare Products Association, a group that represents over-the-counter drug makers, presented no new evidence to counter the FDA staff’s conclusions about phenylephrine during a meeting last year. . However, the group argued that pulling oral phenylephrine from the market would be a significant burden to consumers.

According to the group, a survey found that 1 in 2 households in the US had used an oral decongestant in the past year. It also found that people preferred oral decongestants over nasal sprays by a margin of 3 to 1.

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