FDA issues proposal to remove oral phenylephrine from OTC cold and cough syrups
On Thursday the Food and Drug Administration announced it is proposing to remove oral phenylephrine as an active ingredient that can be used in over-the-counter monograph drug products for the temporary relief of nasal congestion after an agency review of the available data determined that oral phenylephrine is not effective for this use. For now, FDA said companies may continue to market OTC monograph drug products containing oral phenylephrine as a nasal decongestant.
This is a proposed order. Only a final order will affect what products can be marketed. The proposed order is based on effectiveness concerns, not on safety concerns, the FDA said.
Currently, oral phenylephrine is widely used as a nasal decongestant active ingredient in many OTC monograph drug products. It is important to note that some products only contain oral phenylephrine as a single, active ingredient. Others contain oral phenylephrine and another active ingredient (e.g., acetaminophen or dextromethorphan), and the presence of oral phenylephrine in these medicines does not affect how other active ingredients work to treat the symptoms for which they are intended, FDA said.
“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.”
The agency noted that it conducted a comprehensive review of all available data on the safety and efficacy of oral phenylephrine, including the historical data that were used to support the determination made 30 years ago that oral phenylephrine was effective as a nasal decongestant, as well as newer clinical data on oral phenylephrine that have since become available.
Last fall, the FDA also held a Nonprescription Drug Advisory Committee meeting to discuss the ‘Generally Recognized as Safe and Effective’ (GRASE) status of oral phenylephrine as a nasal decongestant. The committee discussed new data on the effectiveness of orally administered phenylephrine and unanimously concluded that the current scientific data do not support that the recommended dosage in the OTC cold, cough, allergy, bronchodilator and antiasthmatic drug products monograph for orally administered phenylephrine’s effectiveness as a nasal decongestant.
“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,” said Theresa Michele, M.D., director of the Office of Nonprescription Drug Products in CDER. “Consumers can also talk to their doctor or pharmacist about ways to treat these symptoms.”
FDA also stated, "Because a variety of different drug products may be sold under the same brand name, consumers should always read the Drug Facts label to determine which ingredients are in a medication, and to be aware of important warnings and directions for use. Phenylephrine is also an ingredient in nasal sprays to treat congestion. The FDA’s action is only related to orally administered phenylephrine and not the nasal spray form."
The FDA is seeking public comments on this proposed order. Instructions on how to submit comments are found in the proposed order available on OTC Monographs@FDA. If, after considering the comments, the FDA concludes oral phenylephrine is not effective as a nasal decongestant, the FDA will issue a final order removing oral phenylephrine from the OTC monograph, and drug products thereafter could no longer contain oral phenylephrine as a nasal decongestant. The FDA would provide manufacturers with appropriate time to either reformulate drugs containing oral phenylephrine or remove such drugs from the market.
The Consumer Healthcare Products Association responded swiftly to the proposal issuing the following statement from Scott Melville, president and CEO:
“CHPA is disappointed in FDA’s proposal to reverse its long-established view of oral PE. For decades, people have relied on oral PE to relieve their nasal congestion. We believe Americans deserve access to safe and effective OTC medicines and the option to choose the products they prefer for self-care.
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“This proposed change is at odds with previous FDA decisions and Advisory Committee recommendations. OTC manufacturers have responsibly adhered to FDA’s acceptance of oral PE as “generally recognized as safe and effective” (GRASE), the scientific and regulatory standard for OTC ingredients. FDA’s long-held determination was based on a thorough review of multiple double-blind placebo-controlled trials, supported by two previous FDA advisory panels, and validated by a meta-analysis of relevant clinical studies. CHPA maintains its position that no changes to the GRASE status of oral PE for nasal decongestion are warranted based on data made available since the previous review in 2007. As science and methods advance, new data should be considered in the context of the full weight of available evidence, not as a complete replacement of the previous body of evidence—especially when considering an ingredient as safely and widely used as PE. CHPA will review the Proposed Order and submit comments accordingly.
“PE is the only oral OTC decongestant available without purchase restrictions and is included in numerous OTC cough and cold medicines labeled with a decongestant claim. Consumers need options for self-care, and freedom of choice for self-care is a core attribute of our nation’s healthcare system. PE should remain an available option for consumers, because Americans deserve the option to choose the safe and effective OTC medicines they prefer and rely on.”
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