The US Food and Drug Administration (FDA) has unveiled its plans to phase out oral phenylephrine as an active ingredient from cold medication, due to its ineffectiveness.
According to the FDA statement, oral phenylephrine is widely used in over-the-counter (OTC) monograph drug products for the temporary relief of nasal congestion.
Its proposal to withdraw the ingredient is based on a review of available data, which showed that oral phenylephrine is not effective for its intended use.
The agency currently allows the drugmakers to continue marketing their OTC monograph drug products containing oral phenylephrine as a nasal decongestant.
The proposed order will have no effect on what products can be marketed and is based on effectiveness concerns, not on safety concerns, said the US health agency.
FDA’s Centre for Drug Evaluation and Research (CDER) director Patrizia Cavazzoni said: “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.”
CDER office of nonprescription drug products director Theresa Michele said: “Consumers should know that a range of safe and effective drugs and other treatments is available to temporarily relieve congestion symptoms due to allergies or a common cold.”
FDA said it has conducted a review of all available data on the safety and efficacy of oral phenylephrine, including the historical data along with the latest clinical data.
The agency previously held a Nonprescription Drug Advisory Committee meeting to discuss the ‘Generally Recognised as Safe and Effective’ (GRASE) status of oral phenylephrine.
The committee unanimously concluded that the current scientific data do not support that orally administered phenylephrine is effective as a nasal decongestant.
FDA urged consumers to read the Drug Facts label to determine which ingredients are present in a medication and to be aware of important warnings and directions for use.
Furthermore, the agency is seeking public comments on the proposed order, with plans to issue a final order for preventing the use of oral phenylephrine from the OTC drug products.
