The U.S. Food and Drug Administration (FDA) has proposed the removal of oral phenylephrine as an active ingredient in over-the-counter (OTC) nasal decongestants. The FDA’s decision comes after a comprehensive review of available data, which concluded that oral phenylephrine is not effective for relieving nasal congestion. The proposal is based on concerns about effectiveness, not safety.
Phenylephrine is currently a widely used active ingredient in many OTC nasal decongestants, including popular brands such as Sudafed PE, Vicks Sinex, and Benadryl Allergy Plus Congestion. Some products contain only oral phenylephrine as a single active ingredient, while others combine it with other active ingredients like acetaminophen or dextromethorphan.
“It is the FDA’s role to ensure that drugs are safe and effective,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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,” she stated in an FDA news release.
The FDA’s proposal is currently open for public comments. If, after considering the comments, the FDA concludes that oral phenylephrine is not effective as a nasal decongestant, it will issue a final order to remove the ingredient from the OTC monograph. Following this, drug products could no longer contain oral phenylephrine as a nasal decongestant. The FDA will provide manufacturers with appropriate time to either reformulate drugs containing oral phenylephrine or remove such drugs from the market.
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