The Food and Drug Administration (“FDA”) said on Thursday that they will seek to pull the common ingredient phenylephrine off the market. Phenylephrine in many popular over-the-counter cold and allergy medications, however per the FDA, the ingredient fails to actually relieve nasal congestion.
The agency said an extensive review of available data determined that that oral phenylephrine doesn’t actually relieve nasal congestion. The FDA said the proposed order is not based on safety concerns, but a final order from the FDA would force pharmacies to cease from selling hundreds of products containing oral forms of the ingredient, which is found in versions of drugs such as NyQuil, Benadryl, Sudafed and Mucinex.
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 need to seek out spray versions of the drug, or other medications with different ingredients. Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a news release: “Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”
Retail pharmacy chain CVS said last year that they had already moved to pull certain medicines containing oral phenylephrine; a final order from the FDA would also require drugmakers such as Procter & Gamble, Bayer, and Johnson & Johnson spinoff Kenvue to reformulate many of their oral cold and allergy products.
The meeting of FDA advisors last year was prompted by researchers at the University of Florida, who found in studies that products containing phenylephrine failed to outperform placebo pills in patients with cold and allergy congestion. In briefing documents posted ahead of the panel meeting last year, FDA staff concluded that oral formulations of phenylephrine do not work at standard or higher doses, with only a very small amount of phenylephrine actually working to relieve congestion.
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