FDA proposes ending use of decongestant found in many cold, allergy medicines
The FDA has proposed ending the use of an ingredient in many over-the-counter cold and allergy medications because it doesn’t actually relieve nasal congestion.
The Food and Drug Administration on Thursday proposed ending the use of a common ingredient found in many popular over-the-counter cold and allergy medications.
The agency said an extensive review of available data determined that the ingredient, oral phenylephrine, doesn’t actually relieve nasal congestion. It comes more than a year after advisors to the FDA unanimously reached the same conclusion.
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,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a release.
The FDA said the proposed order is not based on safety concerns and not final yet, which means companies can still market over-the-counter drugs containing oral phenylephrine for now. But 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.
Last year, CVS said it has already moved to pull certain medicines containing oral phenylephrine.
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