A common ingredient in over-the-counter cold and cough medicines may not last long for the world. The Food and Drug Administration is trying to decide whether oral phenylephrine should remain among over-the-counter nasal decongestants. Outside experts will discuss the issue and give their recommendations this week, but FDA scientists have argued that oral phenylephrine is virtually useless.
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This week, the FDA will host an advisory committee meeting on over-the-counter drugs, with one of the topics being whether oral phenylephrine should be removed from the market as a nasal decongestant. The ingredient is found in many brands of cold and allergy medications, such as Sudafed PE and some formulations of Nyquil. The specific change discussed is whether phenylephrine should lose its current “generally recognized as safe and effective,” or GRASE, designation. Before this meeting, the agency’s own researchers detailed their findings in a report. was released on Thursday.
This same issue was debated in 2007. Although there was some evidence at the time that oral phenylephrine might not be effective, the advisory committee and the FDA were ultimately convinced otherwise by the overall data as well as arguments from the manufacturers. of medicine. the drug is stored in his I may re-examine the decision in the future once further research is completed. In 2015, the FDA was asked by University of Florida researchers to do just that, which led to this new meeting.
Since 2007, several studies have been conducted on the subject, including three large clinical trials. And as the data is now much more definitive. These large placebo-controlled trials show no evidence that standard and higher doses of oral phenylephrine relieve nasal decongestion. While the drug may have a decongestant effect when taken intranasally, other data cited by the FDA found that our bodies barely absorb it when taken orally. In other words, no amount of oral phenylephrine is likely to help with nasal congestion, at least not in a dose that is practical or safe to take instead. FDA scientists also determined that some of the earlier positive studies on the drug had methodological flaws and/or apparent biases.
“We believe that these new pharmacological and clinical data are consistent, substantial, and reliable, and confirm that orally administered (phenylephrine) is ineffective at any dose that can be developed and still provide a reasonable margin of safety, ” reviewers wrote. of the agency in its report. report.
The FDA review is not the final word on the issue. The advisory committee may again recommend that oral phenylephrine remain on the shelves. But even if the panel recommends that, the FDA could still choose to ignore its advice and recall the drug.