Sudafed, Mucinex, Benadryl, Advil, Tylenol, Vicks and DimetApp.
This popular brand name appears in the oral congestion, which is an essential element of cold and flu channel in the US pharmacy.
November 2024, US Food and Drug Administration (FDA) proposal The order to remove the oral phenylprin from the single cold, cough, allergies, bronchial extensions and anti -substance drug products that can be used today. About one quarter of all oral red blood removal.
The proposal is open for public opinion, and when it is completed, the ruling is Hundreds of Purchased in the country -A About US $ market share17.6 billion 2022.
Popular products affected by this proposal include Advil sinus congestion and pain, Sudafed pe nasal decongestant, vicks dayquil and nyquil, and tylenolt & flue severes.
The proposed order began a year after an independent advisory agency for the FDA unanimately unanimously concluded.
For almost 20 yearsSome scientists have I asked for removal Oral phenyl prin in the market. When the FDA finally reviewed the medicine, the drug was kept on the shelf.
“Checking whether the drug is safe and effective is the role of the FDA.” Say Patrizia Cavazzoni, the administration’s drug evaluation and research center (CDER).
“In line with the review of the available data and the advisory committee’s advice, we are performing this step to propose oral phenylprin removal because it is not effective due to nasal collisions.”
To understand how many useless red blood markets are dominated, it is necessary to look back on the history of cold and flu drugs.
PHENYLEPHRINE was first approved by the FDA as a safe and effective congestion in 1976. Industrial funding After that, they were criticized for their methodology.
Prior to 2006, Pseudoepheedrine was a major component of boundaries that could not be purchased without prescription. In the early 2000s, according to the federal law, the state had to take comprehensive measures to control drug sales because of concerns used to manufacture metomphetamine.
Since then, local law has been required to prescribe a medicine containing Shudo Epedrin or the amount that can be sold behind the counter.
After this ruling, pharmacies, groceries, and nationwide convenience stores replaced Pseudoephedrine with phenylephrine.
In 2005, some scientists We reviewed existing evidence It showed that it was not effective in removing the nose when the prin was taken in the dose of the prinyl on the phenyl.
2007 A Petition We asked the FDA to require better efficacy evidence. At the time, however, officials in the administration demanded more research on higher doses.
Clinical trial from 2015 I tried four times Although it is the dose of oral phenyl, this drug is still useless as a red blood removal, and the petitions of other citizens have urged petitions to remove these products from the market.
At the end of the debate over the years, the institution was shaken with overwhelming evidence. In 2023, the FDA Committee analyzed three large clinical trials showing that the oral phenyl is not effective for any capacity.
Even if research is swallowed at high doses, Nearly nothing reaches the nasal cavity. It is mainly broken in the intestine.
The proposed command that removes phenylprin from the oral hypertrophy does not apply to the nasal spray or in the lower descent. These products deliver the same drug in a more effective way than oral purification.
But most consumers do not know these differences. 2022 Cold treatment products with more than 245 million pieces Containing phenylprin was sold in the United States.
Since it is a proposed order, the FDA does not have to do anything yet. But they are notified of additional measures, which may soon be withdrawn from a product containing phenylprin as the only active ingredient.
You can find a list of oral red blood materials containing prin in phenyl. here.
The previous version of this article was published in November 2024.
