The U.S. Food and Drug Administration (FDA) is proposing to remove a common ingredient in nasal decongestants used by millions of Americans, citing data that shows it’s not effective.
Oral phenylephrine is used in over-the-counter products like Sudafed and Dayquil to help temporarily relieve the common symptom of colds and allergies. Phenylephrine has been sold for more than 75 years, predating the agency’s own regulations on drug effectiveness. “It is the FDA’s role to ensure that drugs are safe and effective,” Dr.
Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, said in a statement . “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.” For now, companies may still market products containing oral phenylephrine as a nasal decongestant.
Only a final order will affect what products can be marketed. Some products only contain oral phenylephrine as a single, active ingredient, and others contain oral phenylephrine and another active ingredient. The FDA notes the proposed order is not based on safety concerns, and that the presence of oral phenylephrine in these medicines does not affect how other active ingredients treat symptoms.
In addition, its action is only related to orally administered phenylephrine, and not the nasal spray form. Last fall, .
