2 weeks Ago By Debosmita Ghosh
The Food and Drug Administration proposed to end the use of a common ingredient, oral phenylephrine, in over-the-counter cold and allergy medications. The agency said that an extensive review of available data determined that the ingredient doesn’t actually relieve nasal congestion, according to a report in NBC News. This comes more than a year after advisors to the FDA unanimously reached the same conclusion.
Dr Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research in a release said that based on the data, “we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.” The agency said that the order is not based on safety concerns and is not final yet, which means companies can still market over-the-counter drugs containing oral phenylephrine for now. However, a final decision would force pharmacies to clear shelves of hundreds of products containing oral forms of the ingredient, which is found in versions of drugs such as NyQuil, Benadryl, Sudafed and Mucinex.
A final order would also require drugmakers such as Procter & Gamble, Bayer, and Johnson & Johnson spinoff Kenvue to reformulate many of their oral cold and allergy products, said an NBC News report. 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 scramble to seek out spray versions of the drug, or other medications with different ingredients, both of which the FDA’s decision does not affect.
The meeting of FDA advisors last year was prompted by researchers at the University of Florida, who petitioned the agency to remove phenylephrine products from the market based on studies showing they failed to outperform placebo pills in patients with cold and allergy congestion. The researchers also challenged the drug’s effectiveness in 2007. However, the FDA allowed the products to remain on the market pending additional research.
Representatives for the Consumer Healthcare Products Association which is a group that represents over-the-counter drug manufacturers did not offer any new evidence to counter the FDA staff’s conclusion about phenylephrine during the 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 U.
S. used an oral decongestant over the last year. It also found people prefer oral decongestants over nasal spray by a 3-to-1 margin.
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