United States: An advisory committee under the aegis of the US health agency decided that phenylephrine is useless against nasal congestion.
The US FDA has suggested that it should be stripped from popular over-the-counter decongestants.
More about the news
According to the FDA, as a matter of fact, “it is important to note that some products only contain oral phenylephrine as a single, active ingredient,” US News reported.
Nevertheless, according to the data available to the science, it is high time customers stopped wasting their hard-earned money on such products, pointed out the FDA.
FDA statements
According to Dr. Patrizia Cavazzoni, who directs the FDA’s Center for Drug Evaluation and Research (CDER), “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,” Cavazzoni added.
The agency said its experts studied data compiled over the years on whether phenylephrine could actually help unblock congestion.
However, they could not even provide any facts to prove that or to back up the idea that phenylephrine may enhance the impact of other medicines added to decongestants, like acetaminophen or dextromethorphan.
Currently, the FDA action is still only in a proposed form; the agency will be accepting comments on the proposed rule until May 7, after which time the agency may proceed to a final rule to remove phenylephrine from the shelves.
Arising from the current proposal by the FDA only concerns phenylephrine in capsule or syrup formulation and not the nasal spray form.
As Jennifer Schwartzott, the patient representative on the panel, said, “I feel this drug in this oral dose should have been removed from the market a long time ago. Patients require and deserve medications that treat their symptoms safely and effectively, and I don’t believe that this medication does that.”
Those containing phenylephrine were more popular after pseudoephedine – a very effective decongestant – became less available in 2005 due to measures claiming to tackle the meth problem.
Nearly 242 million bottles or packages of phenylephrine containing cold remedies are reportedly sold in 2022 while about 51 million cold products containing pseudoephedine, FDA briefing documents of the meeting presented.
“We believe that these new clinical pharmacology and clinical data are consistent, substantial, and believable, and they confirm that orally administered phenylephrine is not effective at any dose that can be developed and still provide a reasonable margin of safety,” the documents added.