FDA set to ban certain over-the-counter cold medications
The U.S. Food and Drug Administration (FDA) would like products containing phenylephrine, the primary drug in popular over-the-counter nasal decongestants and cold medications, to be removed from store shelves.
The FDA said its proposed order comes after mounting evidence showing the drug is ineffective. The determination is not based on concerns over safety.
“It is the FDA’s role to ensure that drugs are safe and effective,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER) said in a statement. “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.”
Notably, the order applies only to phenylephrine in oral products, such as capsules and liquids. Nasal sprays that contain the drug would not be subject to the order, as the evidence for their efficacy is more substantial.
The FDA released documents to support its reasoning, including a long-running review that showed oral phenylephrine is not effective. The results, based on multiple clinical studies, were released last year and spurred the FDA to initially comment on the lack of evidence for the drug’s effectiveness.
Regardless of the FDA’s wishes, oral phenylephrine products will remain available for now, and companies are free to continue marketing them. A final determination has not been made, and the proposed order is now subject to public comment.
The full proposed order is available here.
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