The FDA wants to pull cold and flu medications from drugstore shelves after research showed the main ingredient was useless in treating the viruses.
The agency on Thursday proposed discontinuing the use of phenylephrine, an ingredient in common medications such as Sudafed and Benadryl, because it is “ineffective” in treating or relieving virus symptoms such as a stuffy nose.
The key ingredient in a wide variety of over-the-counter oral decongestants has been thought to be ineffective for years, and in March 2023, the FDA began reviewing the use of phenylephrine after a meta-analysis found it was no more effective than a placebo. .
When phenylephrine is metabolized in the intestines, it cannot reach the bloodstream in sufficient amounts, rendering it useless in providing relief.
Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER), said in the FDA release: notification: ‘The FDA’s role is to ensure that medications are safe and effective.
“Based on our review of the available data, and in accordance with the advisory committee’s advice, we are taking this next step in the process of proposing to remove oral phenylephrine because it is not effective as a nasal decongestant.”
Phenylephrine is the main active ingredient in common over-the-counter cold medications, such as Sudafed
This is only a ‘proposed order’ and will have no immediate impact on the medications. Only a ‘final order’ affects which products are sold.
The FDA added, “The proposed order is based on effectiveness concerns, not safety concerns.”