In a long-sought move, the Food and Drug Administration on Thursday formally began the process of phasing out oral doses of a commonly available over-the-counter decongestant that the agency concluded last year is ineffective at relieving stuffy noses.
Specifically, the FDA has issued a proposal to remove oral phenylephrine from the list of medications that drug manufacturers can include in over-the-counter products – also known as the OTC monograph. Once removed, drug manufacturers will no longer be able to include phenylephrine in products for the temporary relief of nasal congestion.
“The FDA's role is to ensure that medications are safe and effective,” Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said in a statement. “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 to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”
For now, the order is just a proposal. The FDA will open a public comment period, and if no comment could affect the FDA's previous conclusion that the drug is useless, the agency will make the order final. Drug manufacturers are given a grace period to reformulate their products.
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The slow-moving phaseout of phenylephrine has been in the works for years. The decongestant was originally approved by the FDA in 1976, but didn't gain fame until 2006. That was the year the Combat Methamphetamine Epidemic Act of 2005 went into effect and pseudoephedrine – the main ingredient in Sudafed – took a back seat. pharmacy counter to prevent it from being used to make methamphetamine. Because pseudoephedrine was not easily accessible at drugstores, phenylephrine became the main over-the-counter decongestant. And researchers had questions.
In 2007, an FDA panel re-evaluated the drug, which reportedly works by narrowing the blood vessels in the nasal cavity, thereby opening the airways. While the panel upheld the drug's approval, it concluded that more studies were needed for a full review. Three large, carefully designed studies were then conducted: two by Merck for the treatment of seasonal allergies and one by Johnson & Johnson for the treatment of the common cold. All three found no significant difference between phenylephrine and a placebo.
