The FDA wants to pull common cold and flu medications from drugstore shelves after studies found the main ingredient was useless in treating the viruses.
The agency proposed on Thursday discontinuing the use of phenylephrine, an ingredient in common medications like Sudafed and Benadryl, because it ‘is not effective’ in treating or relieving virus symptoms such as nasal congestion.
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 metabolized in the gut, phenylephrine can’t reach the bloodstream in sufficient levels, rendering it useless in providing relief.
Dr Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER), said in the agency’s notice: ‘It is the FDA’s role to ensure that drugs are safe and effective.
‘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.’
Phenylephrine is the main active ingredient in common over-the-counter cold medications like Sudafed
This is only a ‘proposed order’ and will not have an immediate impact on the medications. Only a ‘final order’ will affect what products are sold.
The FDA added: ‘The proposed order is based on effectiveness concerns, not on safety concerns.’
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