The Food and Drug Administration (FDA) has initiated the process to remove oral phenylephrine from the list of drugs that can be included in over-the-counter (OTC) products, following conclusions that it is ineffective in relieving nasal congestion. This action comes after years of debate and reevaluation of the drug's efficacy.
Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, stated, "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 proposal is open for public comment, after which the FDA will decide whether to finalize the order. If finalized, drug manufacturers will be given time to reformulate their products.
History of Phenylephrine
Phenylephrine was initially approved by the FDA in 1976 but became a leading OTC decongestant after the "Combat Methamphetamine Epidemic Act of 2005" restricted access to pseudoephedrine, a key ingredient in Sudafed, due to its use in methamphetamine production. This shift led to increased reliance on phenylephrine as an alternative.
Efficacy Concerns and Studies
In 2007, an FDA panel reevaluated phenylephrine, which is purported to work by constricting blood vessels in the nasal passages to alleviate congestion. While the panel upheld the drug's approval at the time, it called for further studies to fully assess its effectiveness. Subsequently, three large, well-designed studies—two by Merck for seasonal allergies and one by Johnson & Johnson for the common cold—found no significant difference between phenylephrine and a placebo.
