"It is the FDA's role to ensure that drugs are safe and effective," Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said in a statement. "Based on our review of available data and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant."
The slow-moving abandonment of phenylephrine is years in the making. The decongestant was originally approved by the FDA in 1976, but it came to prominence after the 'Combat Methamphetamine Epidemic Act of 2005' came into effect.
For now, the order is just a proposal. The FDA will open up a public comment period, and if no comments can sway the FDA's previous conclusion that the drug is useless, the agency will make the order final.
Researchers had questions. In 2007, an FDA panel reevaluated the drug, which supposedly works by shrinking blood vessels in the nasal passage, opening up the airway. While the panel upheld the drug's approval, it concluded that its effectiveness was uncertain.
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