FDA Considers Pulling Ineffective Oral Phenylephrine from Over-the-Counter Medicines

The FDA is considering pulling oral phenylephrine from over-the-counter nasal decongestants due to evidence it may be ineffective.
Oral phenylephrine is commonly found in brands like Sudafed PE and Nyquil. The FDA previously approved it in 2007.
Recent placebo-controlled trials found no evidence that standard or higher doses of oral phenylephrine relieve nasal congestion.
The FDA now believes new data shows oral phenylephrine is not absorbed by the body and thus ineffective against nasal congestion.
The FDA advisory panel will make recommendations this week, but the FDA can still decide to remove oral phenylephrine regardless of their advice.

gizmodo.com

Relevant topic timeline:

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