FDA issue order against common ingredient found in cold and flu medicine

The US Food and Drug Administration (FDA) has proposed an order to ban a popular ingredient in cold and flu medicines as it is seemingly not as effective as other methods.

Oral phenylephrine is often found in many over-the-counter cold and flu treatments, including Benadryl, Advil, and Tylenol.

The FDA investigated all of the readily available data based on the safety and efficiency of oral phenylephrine dating back 30 years ago which suggested oral phenylephrine was effective as a nasal decongestant. They also looked at the latest findings.

The agency came to the unanimous decision that the latest data does not support orally administered phenylephrine’s effectiveness as a nasal decongestant.

"It is the FDA's role to ensure that drugs are safe and effective," Patrizia Cavazzoni, director of the administration's Center for Drug Evaluation and Research (CDER), said.

"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."

The FDA's order is only related to orally administered phenylephrine and not the nasal spray form.

"Consumers should know that a range of safe and effective drugs and other treatments is available to temporarily relieve congestion symptoms due to allergies or a common cold," Theresa Michele, M.D., director of the Office of Nonprescription Drug Products in CDER, said. "Consumers can also talk to their doctor or pharmacist about ways to treat these symptoms."

The FDA is now seeking public comments on the proposed order, explaining that once they've considered the comments and concluded its effectiveness, they will issue a final order to remove oral phenylephrine. This means many medicines could no longer contain oral phenylephrine as a nasal decongestant.

The FDA said they will ensure manufacturers will give appropriate time to remove such drugs from the market.

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