The FDA wants to pull common cold and flu medications from pharmacies after studies found the main ingredient was useless in treating viruses.
The agency on Thursday proposed suspending the use of phenylephrine, an ingredient in common medications such as Sudafed and Benadryl, in over-the-counter products because it is “not effective” in treating or relieving symptoms of the virus, such as nasal congestion.
The key ingredient in a wide variety of over-the-counter nasal decongestants has been thought to be ineffective for years, and in March 2023, the FDA began reviewing the use of phenylephrine after a meta-analysis found it was no more effective than a placebo. .
When metabolized in the intestine, phenylephrine cannot reach the bloodstream in sufficient levels, making it useless in providing relief.
Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER), said in the agency’s report warning: ‘The FDA’s role is to ensure that medications are safe and effective.
“Based on our review of the available data, and in accordance with the advice of the advisory committee, we are taking the next step in the process to propose the elimination of oral phenylephrine because it is not effective as a nasal decongestant.”
The proposed order only applies to the active ingredient phenylephrine, which is sold under brand-name products.
However, phenylephrine is sometimes used in products along with other medications and the FDA said it “does not affect the way other active ingredients work to treat the symptoms for which they are intended.”
Phenylephrine is the main active ingredient in common over-the-counter cold medicines, such as Sudafed.
Common active ingredients that phenylephrine is used with include acetaminophen, which is sold as a pain reliever, and dextromethorphan, which is sold as a cough suppressant.
This is only a “proposed order” and will not have an immediate impact on the medications. Only a ‘final order’ will affect the products sold.
The FDA added: “The proposed order is based on efficacy issues, not safety issues.”
The proposal is based on “a comprehensive review of all available data on the safety and effectiveness of oral phenylephrine,” dating back three decades, when the drug was first thought to be effective as a decongestant, as well as in most recent research.
Last fall, the FDA’s Nonprescription Drug Advisory Committee met to discuss the “Generally Recognized as Safe and Effective” (GRASE) status of phenylephrine and, based on new data, unanimously concluded that “current scientific data do not support…the effectiveness of phenylephrine.” as a nasal decongestant.
The FDA noted, however, that its conclusion only applies to phenylephrine taken orally, not intranasally in common nasal decongestants.
The agency is seeking public comment on the matter, and if, after considering input, the FDA concludes that phenylephrine is not effective as an oral decongestant, it will issue a final order removing it from over-the-counter medications.
Following that ruling, pharmaceutical products could no longer contain oral phenylephrine.
Dr. Theresa Michele, director of CDER’s Office of Nonprescription Drugs, said, “Consumers should know that a variety of safe and effective medications and other treatments are available to temporarily relieve congestion symptoms due to allergies or a cold. common.
“Consumers can also talk to their doctor or pharmacist about ways to treat these symptoms.”