FDA Proposes Removal of Common Oral Cold Medication Ingredient as ‘Ineffective’

The U.S. Food and Drug Administration (FDA) announced on Nov.

7 that it is proposing to remove oral phenylephrine, a widely used active ingredient in over-the-counter (OTC) cold medications, from the market. After an extensive review of scientific data, the FDA concluded that oral phenylephrine is ineffective for relieving nasal congestion. Oral phenylephrine is present in numerous OTC products, both as a standalone ingredient and in combination with others like acetaminophen or dextromethorphan.

Several over-the-counter medications contain oral phenylephrine as a nasal decongestant, including brands such as Sudafed PE, Vicks DayQuil, Tylenol Sinus Congestion & Pain, and Robitussin Peak Cold Nasal Relief. The FDA emphasized that the ineffectiveness of phenylephrine does not impact the efficacy of these other ingredients in treating symptoms such as pain or cough. “It is the FDA’s role to ensure that drugs are safe and effective,” said Patrizia Cavazzoni, M.

D., director of the FDA’s Center for Drug Evaluation and Research. “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.

” Until a final order is issued, manufacturers can continue to market OTC products containing oral phenylephrine. The FDA is seeking public comments on the proposal, which focuses on effectiveness concerns rather than.