FDA proposes to ban popular decongestants in frigid medicines, citing ‘ineffectiveness’

The US Food and Drug Administration (FDA) has proposed a ban on the oral exploit of phenylephrine, the lively ingredient in popular decongestants and frigid medications, citing its lack of effectiveness.

Several frigid medications, including Advil, Vicks NyQuil, Sudafed PE, Robitussin, Benadryl Allergy Plus Congestion, Tylenol, and Theraflu, contain oral phenylephrine. In some cases it is the only lively ingredient, while in others it is combined with acetaminophen or dextromethorphan.

Officials clarified that the proposed ban is unrelated to the safety of phenylephrine and does not affect phenylephrine nasal spray.

Companies may continue to sell products containing oral phenylephrine until the order is finalized. The public can submit comments on the FDA’s proposal until May 7, 2025. However, after this period, when the FDA finalizes its decision to revoke oral phenylephrine’s “Generally Recognized as Sheltered and Effective” (GRASE) status, manufacturers will have to either remove or change the formula of products containing this ingredient. The FDA has stated that it will provide manufacturers with an appropriate transition period in such cases.

“The role of the FDA is to ensure the safety and effectiveness of drugs. Based on our review of the available data and in line with the advice of the advisory committee, we are taking the next step in the process of proposing the removal of oral phenylephrine because it is not effective as a nasal decongestant,” said Dr. Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research (CDER). ) FDA in the study press release.

Meanwhile, officials are urging consumers to be mindful of the ingredients in over-the-counter (OTC) medicines, advising them to read drug labels and follow crucial warnings and directions for exploit.

“Consumers should know that a range of unthreatening and effective medicines and other treatments are available to temporarily relieve the symptoms of airway obstruction caused by allergies or the common frigid. Consumers can also talk to their doctor or pharmacist about ways to treat these symptoms, Dr. Theresa Michele, director of the Office of Over-the-Counter Drug Products at CDER.

However, Consumer Healthcare Products Association (CHPA) officials. he said are “disappointed” with the proposed ban and maintain their position that “no change to the GRASE status of oral PE (phenylephrine) for the treatment of nasal congestion is warranted.”

“PE should remain an available option for consumers because Americans deserve to be able to choose the unthreatening and effective OTC medicines they prefer and rely on,” CHPA said in a news release.