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, in over-the-counter products 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 nasal 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.’
The proposed order only applies to the active ingredient phenylephrine, which is sold under brand-name products.
However, sometimes phenylephrine is used in products alongside other drugs and the FDA said it ‘does not affect how other active ingredients work to treat the symptoms for which they are intended.’
Phenylephrine is the main active ingredient in common over-the-counter cold medications like Sudafed
Common active ingredients phenylephrine is used with include acetaminophen – sold as a pain reliever – and dextromethorphan – sold as a cough suppressant.
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.’
The proposal is based on ‘a comprehensive review of all available data on the safety and efficacy of oral phenylephrine,’ which dates back three decades when the drug was first thought to be effective as a decongestant, as well as more recent research.
Last fall, the FDA’s Nonprescription Drug Advisory Committee met to discuss the ‘Generally Recognized as Safe and Effective’ (GRASE) status of phenylephrine, and based on new data, it unanimously concluded that ‘current scientific data do not support… phenylephrine’s effectiveness as a nasal decongestant.’
