The Food and Drug Administration (FDA) has announced a proposal to remove oral phenylephrine from the market, a widely used ingredient in over-the-counter cold and cough medicines, after determining it is ineffective as a nasal decongestant when taken orally. This decision follows a comprehensive review of available data and aligns with the recommendations of the agency's advisory committee.
Scientific Basis for the Proposal
The FDA's decision is rooted in scientific evidence indicating that oral phenylephrine is poorly absorbed into the bloodstream. A recent FDA review concluded that less than 1% of the drug is absorbed after being swallowed, a figure significantly lower than previously estimated. This minimal absorption renders the drug ineffective at the doses currently approved for over-the-counter use.
"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," stated Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, in a press release.
Impact on Consumers and Manufacturers
The proposed order would remove oral phenylephrine from the "monograph" of ingredients that drugmakers are allowed to use in over-the-counter cough and cold medicines. The public has until May 7 of next year to submit comments on the proposal. If the FDA finalizes the proposal, drug manufacturers will be required to either reformulate their products or remove them from the market. The FDA has stated that it will provide manufacturers with sufficient time to make these changes.
Industry Response
The Consumer Healthcare Products Association (CHPA), a trade group representing over-the-counter drug manufacturers, expressed disappointment with the FDA's proposal. They maintain that oral phenylephrine should remain available to consumers as a safe and effective option. Scott Melville, CHPA's president and CEO, stated that "Americans deserve the option to choose the safe and effective OTC medicines they prefer and rely on."
Historical Context and Prior Actions
The FDA's proposal comes after years of scrutiny and debate regarding the effectiveness of oral phenylephrine. Pharmacy professors at the University of Florida have been vocal critics, presenting data that showed phenylephrine performed no better than a placebo in clinical trials. In light of these concerns, CVS, a major pharmacy chain, had previously removed products containing only phenylephrine from its shelves.
Safety Considerations
It is important to note that the FDA's concerns relate to the drug's effectiveness, not its safety. As stated by University of Florida professor, Hatton, "Let me be clear, oral phenylephrine is not a safety risk. It just doesn't work."
Alternative Treatments
While oral phenylephrine may be removed from the market, other decongestant options remain available. Nasal sprays containing phenylephrine, which deliver the drug directly to the nasal passages, are not affected by this proposal. Additionally, other decongestant ingredients, such as pseudoephedrine, are available, though often kept behind the pharmacy counter due to regulatory restrictions.
