A uncouth factor in over - the - comeback cold and cough medicine might not be long for this globe . The Food and Drug Administration is about to make up one’s mind whether unwritten phenylephrine should remain in OTC nasal decongestant drug . external expert will debate the topic and bid their recommendations this hebdomad , but FDA scientists have already fence that unwritten phenylephrine is practically worthless .
This workweek , the FDA is hosting an consultive citizens committee meeting on nonprescription drug , with one of the subject being whether oral phenylephrine should be pulled from the market as a nasal decongestant . The fixings is found in many cold and allergy medicine brands , such as Sudafed PE and certain formulation of Nyquil . The specific modification being deliberate is whether phenylephrine should lose its current appointment of being “ Generally Recognized as good and Effective , ” or GRASE . In advance of this meeting , the federal agency ’s own researchers detailed their conclusions in a reportreleasedlast Thursday .
This same interrogative sentence was debated in 2007 . Though there wassome evidenceback then that oral phenylephrine might be ineffective , the consultatory committee and FDA were ultimately convinced otherwise by the overall data point as well as the arguments made by cold medicinal drug makers , so the drug stayed put . However , the agency did state that it might reevaluate the decision in the future once more inquiry was concluded . In 2015 , the FDA waspetitionedby researchers from the University of Florida to do just that , which has led to this new meeting .
Image: Ground Picture (Shutterstock)
Since 2007 , there have been several studies on the topic , including three large clinical trials . And it appear that the data nowadays is much more authoritative . These large placebo - controlled trial have shownno evidencethat standard and even higher dose of oral phenylephrine relieve nasal decongestion . While the drug might have a decongestant result when taken intranasally , other information cited by the FDA has found that our bodies barely absorb it when taken by word of mouth . In other words , it ’s likely that no amount of unwritten phenylephrine will help your stuffy nozzle , at least not at a dosage that would be hardheaded or safe to take over - the - counter . The FDA scientist also determined that some of the past positive studies on the drug had glaring methodological flaws and/or biases .
“ We trust that these new clinical pharmacological medicine and clinical datum are consistent , substantial , and credible , and they corroborate that orally administered [ phenylephrine ] is not effective at any dose that can be developed and still leave a reasonable tolerance of prophylactic , ” the agency ’s commentator wrote in their report .
The FDA ’s review is not the last countersign on the subject . It ’s possible that the consultatory committee will recommend once again that unwritten phenylephrine remains on shelf . But even if the control panel does urge that , the FDA can still take to ignore their advice and pull the drug anyway .
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