It may not be long before common ingredients in over-the-counter cold and cough medicines are common throughout the world. The Food and Drug Administration is deciding whether oral phenylephrine should be included in over-the-counter nasal decongestants.Considered by external experts However, FDA scientists have already claimed that oral phenylephrine is virtually worthless.
This week, the FDA is hosting a meeting of its OTC Advisory Committee, and one of the topics on the agenda is whether oral phenylephrine should be taken off the market as a nasal obstruction drug. This ingredient is found in many cold and allergy medicine brands, including certain formulations of Sudafed PE and Nyquil. The specific change being discussed is whether phenylephrine should lose its current designation of “generally recognized as safe and effective,” or GRASE. Prior to the meeting, agency researchers detailed their conclusions in a report. released Last Thursday.
This same issue was discussed in 2007 as well. some evidence At the time, it was thought that oral phenylephrine might not be effective, but the advisory committee and the FDA ultimately believed otherwise based on the overall data and discussions with cold medicine manufacturers, and the drug It was used as is.However, the agency stated that The decision may be reevaluated in the future once further research is concluded. In 2015, the FDA petitioned This new conference, proposed by researchers at the University of Florida, is aimed at doing just that.
Since 2007, several studies have been conducted on this topic, including three large clinical trials. And today’s data seems more solid. These large-scale, placebo-controlled trials no evidence Standard and even higher doses of oral phenylephrine reduce nasal congestion. While the drug may be effective at clearing nasal congestion when taken intranasally, other data cited by the FDA found that our bodies absorb very little when taken orally. In other words, no amount of oral phenylephrine may improve nasal congestion, at least at doses that are practical or safe to take over the counter. FDA scientists also determined that some previous positive studies of the drug had obvious methodological flaws and biases.
“We believe these new clinical pharmacology and clinical data are consistent, substantive and reliable, supporting efficacy with oral administration. [phenylephrine] “Any dose that can be developed that still provides a reasonable margin of safety is ineffective,” the agency’s reviewers wrote in their report.
The FDA review is not the final decision on this matter. The advisory committee may again recommend that oral phenylephrine remain on the shelves. But even if a committee recommends it, the FDA can choose to ignore their advice and discontinue the drug anyway.
