A common ingredient in over-the-counter cold and cough remedies may not be around for much longer. The FDA is trying to decide whether oral phenylephrine should remain in over-the-counter nasal decongestants.External experts will review and made their recommendations this week, FDA scientists have concluded that oral phenylephrine is virtually useless.
This week, the FDA will host an Over-the-Counter Drugs Advisory Committee meeting, and one of the topics at the meeting will be whether oral phenylephrine should be withdrawn from the market as a nasal decongestant. This ingredient is found in many brands of cold and allergy medicines, such as Sudafed PE and certain formulations of Nyquil. The specific change being discussed is whether phenylephrine should lose its current “generally recognized as safe and effective,” or GRASE, designation. Ahead of the meeting, the agency’s own researchers detailed their findings in a report. freed last Thursday.
The same issue was debated in 2007. some evidence At the time, oral phenylephrine was likely ineffective, and the advisory committee and FDA were ultimately convinced that was not the case based on aggregate data and arguments from the cold medicine manufacturers, so the drug was retained. Who may re-evaluate this decision in the future once more studies are completed. In 2015, the FDA required Researchers at the University of Florida did just that, which led to this new conference.
Since 2007, several studies have been conducted on this topic, including three large clinical trials. And today’s data seems even more conclusive.These large placebo-controlled trials showed No evidence Oral phenylephrine at standard or even higher doses may relieve nasal congestion. While the drug may have decongestant effects 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 relieve nasal congestion, at least not at doses that are practical or safe to take. FDA scientists also determined that some early positive studies on the drug had methodological flaws and/or apparent bias.
“We believe these new pharmacological and clinical data are consistent, substantial and credible and confirm that oral (phenylephrine) is ineffective at any dose that can be developed but still provides a reasonable margin of safety, ” the reviewer wrote. the agency noted 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 shelf. But even if the panel recommends doing so, the FDA could still choose to ignore its advice and recall the drug. .
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