By Michael DePeau-Wilson
Source Medpagetoday
The FDA announcedopens in a new tab or window on Thursday a proposed order to remove oral phenylephrine as an active ingredient in over-the-counter (OTC) nasal decongestion drugs after a comprehensive review of the available data showed it was not effective.
The agency pointed out that since this is a proposed orderopens in a new tab or window companies can continue to market these products until the final order is announced. The order is not based on safety concerns.
“It is the FDA’s role to ensure that drugs are safe and effective,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER). “Based on our review of available data, and consistent with the advice of the advisory committeeopens in a new tab or window, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”
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