Is Cold Medicine Useless? FDA Finds Ingredient In Common Nasal Decongestants Ineffective

The Food and Drug Administration (FDA) announced on Thursday that it is looking to remove oral phenylephrine from over-the-counter medications because it doesn't work. Phenylephrine is a common ingredient in cold and allergy medications.

The decision was made following the FDA's comprehensive review of available data on the efficacy and safety of oral phenylephrine. It included information spanning over three decades--from studies 30 years ago that proved the ingredient was an effective nasal decongestant, to newer clinical data.

The agency emphasized that the ingredient is not a health hazard and that the proposal to remove it from shelves is based on its effectiveness in treating symptoms as intended, not because of safety concerns.

"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," explained Patrizia Cavazzoni, M.D., FDA director for Center for Drug Evaluation and Research, in a news release.

The agency added that action is being proposed only for oral medication and not phenylephrine in nasal form.

The products may continue to be sold in stores until a final order is made by the agency. The FDA also welcomes comments from experts and the public on the proposed order which it will consider until May 7, before it makes its final decision.

Phenylephrine was approved by the FDA to be used for relief from nasal congestion in 1976, Fox 26 noted. Three decades later, it had become the main ingredient in many OTC medications, including some of the leading brands available in the market.