The Food and Drug Administration announced Wednesday that it would seek to pull a widely used ingredient in cough and cold medicines from the market, after the agency’s scientists concluded that the oral version of the drug is ineffective as a nasal decongestant.
The FDA’s proposal comes more than a year after the agency’s outside advisers voted against continued use of the ingredient, called oral phenylephrine, citing concerns with the initial data used to support its approval and new data questioning its effectiveness.
A number of common over-the-counter nasal decongestants have relied on phenylephrine alone or in combination with other ingredients for years, including some cold and cough versions of Advil, NyQuil, Sudafed, Robitussin, Tylenol and Theraflu.
“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,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a news release.
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