Sudafed, Mucinex, Benadryl, Advil, Tylenol, Vicks, and DimetApp.
These popular brand names are listed in Oral Antler, a staple food in the cold and flu aisles at American drugstores, but many contain ingredients that don’t function as promised.
In November 2024, the US Food and Drug Administration (FDA) proposed an order to remove oral phenylephrine from all cold, cough, allergy, bronchodilators and anti-asthma drug products available today. Approximately 4/5 of the definitive layer of all oral intestine.
The proposal is currently open for public comments and, if completed, the judgment is Hundreds of commercial oral laminae Available in the country – a Market share is equivalent to approximately US$1.76 billion 2022.
Popular products affected by the proposal include crowds and pain from Advil Sinus, Sudafed PE Nasal Decongestant, Vicks Dayquil and Nyquil, and severe Tylenol Cold & Flu.
The proposed order comes a year after the independent FDA advisory body unanimously concluded that oralphenylephrine is safe to consume, but it is better to clean a stifle than a placebo.
Nearly 20 yearssome scientists have I called for removal of oral phenylephrine from the market. When the FDA last reviewed the medicine, it kept the medicine on the shelf.
“It is the FDA’s role to ensure that drugs are safe and effective.” say Director of Patrizia Cavazzoni, Centre for Drug Evaluation and Research (CDER).
“Based on a review of available data, consistent with the advice of the Advisory Committee, we are taking the next step in this process to propose the removal of oral phenylephrine, as we are not effective as oral gut urinators.”
To understand how much of the drug market has been dominated by useless waste producers, we need to look back at the history of cold and flu drugs.
Phenylephrine was first approved by the FDA in 1976 as a safe and effective detritus layer, based on most cases. Industry funding Since then, research has been criticized for its methodology.
Before 2006, Pseudoephedrine was the main ingredient in commercially available slits. In the early 2000s, federal law called on states to take comprehensive measures to control drug sales due to concerns being used in the manufacture of methamphetamine.
Since then, local laws have either required a prescription for a drug containing pseudoephedrine or limited amounts available to sell from behind the counter.
After this ruling, commercially available strips of drug stores, grocery stores and convenience stores nationwide were replaced with phenylephrine.
Some scientists in 2005 Existing evidence has been reviewed It showed that phenylephrine was ineffective in removing the nose when taken verbally at the advised dose.
2007, a Citizen’s petition I asked the FDA to need better evidence of effectiveness. But at the time, administration officials sought more research into higher doses.
Clinical trials since 2015 I tried Quadrupling The oral phenylephrine dosage has proven that the drug remains unhelpful as an intestinal release agent, prompting another citizen’s petition to remove these products from the market.
After years of debate, government agencies were swayed by overwhelming evidence. In 2023, the FDA committee analyzed three large clinical trials showing that oral phenylephrine is not effective at any dose.
Research has shown that even if swallowed at higher doses, Few medicines reach the nose passages. It is mainly broken down in the intestines.
The proposed order of removing phenylephrine from the oral branch layer does not apply to nasal sprays or eye drops. These products provide the same drug in a more effective way than oral tablets.
However, most consumers do not recognize these differences. 2022, Over 242 million cold remedy products In the United States, which includes phenylephrine, more than four times as many pseudoephedrine was sold.
Because it is a proposed order, the FDA has not yet requested that businesses do anything. However, they must immediately draw out products containing phenylephrine as the only active ingredient, as they have been notified for further action.
You can find a list of oral branch layers containing phenylephrine here.
An earlier version of this article was published in November 2024.
