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These 7 Cold and Flu Drugs Are About to Be Banned by the FDA
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These 7 Cold and Flu Drugs Are About to Be Banned by the FDA

With flu season booming, finding effective medications to relieve pesky symptoms is essential to understanding how to recover faster from the flu. There are many cold and flu medications on the market, and it can be difficult to know what to take when you’re sick. But the pool may be about to get smaller. The United States Food and Drug Administration (FDA) announcement that it is considering banning products containing phenylephrine, an ingredient found in many over-the-counter oral cold and flu medications.

The FDA announced a proposal to remove oral phenylephrine, found in many popular over-the-counter decongestants, from shelves. The reason for the ban is that the ingredient simply isn’t effective, according to the FDA.

Meet the experts: Jamie Alan, Ph.D., is an associate professor of pharmacology and toxicology at Michigan State University; Linda N. Lee, MD., is an assistant professor of otolaryngology and head and neck surgery at Harvard Medical School and an otolaryngologist at Massachusetts Eye and Ear.

“It is the FDA’s role to ensure that drugs are safe and effective,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “Based on our review of available data and consistent with the advice of the advisory committee, we are taking the next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant. »

This didn’t come out of nowhere: Last year, an FDA advisory committee determined that phenylephrine was ineffective. CVS announcement it subsequently no longer stocked products containing oral phenylephrine, but many other major pharmacies still sell these drugs.

The news has raised many questions about phenylephrine, as well as products that contain it. Here’s what you need to know, including a list of products containing the ingredient.

What is phenylephrine?

Phenylephrine is a medication used to relieve nasal congestion caused by colds, allergies and hay fever, according to the United States National Library of Medicine.

The drug is designed to constrict blood vessels, explains Jamie Alan, Ph.D., associate professor of pharmacology and toxicology at Michigan State University. “If there is congestion, this will tighten the blood vessels in the nose and there will be less fluid leaking, easing the congestion,” says Alan.

Phenylephrine is an over-the-counter medication.

What products contain phenylephrine?

There are many. Here are some of the most popular products containing oral phenylephrine:

  • PE Sudafé
  • Vicks DayQuil
  • Mucinex Sinus-Max
  • Théraflu
  • Tylenol Sinus
  • Advil Congestion
  • NyQuil Severe cold and flu

What does it mean if you have products containing phenylephrine?

From this second on, it no longer means anything. The proposed ban has nothing to do with security concerns per se. And the FDA ban would not take effect immediately, if it happens. Instead, the proposal will launch a six-month public comment period. After that, the FDA will make a final decision on whether to remove products containing phenylephrine.

However, based on what the FDA has said (and what the evidence suggests), the drug is unlikely to do anything for your nasal congestion, at least, based on phenylephrine alone. (Some of these products contain other ingredients like acetaminophen or ibuprofen that may help you feel better, FDA explain.)

What does the evidence say about phenylephrine?

Data has shown that phenylephrine does not work to relieve congestion. A Randomized, Placebo-Controlled Trial study with 39 people exposed to grass pollen. They then gave them medications containing either phenylephrine, pseudoephedrine (another decongestant), or a placebo. Researchers found that phenylephrine had about the same results as placebo in relieving congestion.

A scientific journal of 33 clinical trials of phenylephrine also found that the drug did not provide “substantial relief” compared to a placebo. And there is a lot others like it.

Why was phenylephrine approved in the first place?

Phenylephrine has been recognized for years as ineffective by many in the medical community. In fact, the American Chemical Society recently called it a “fake decongestant.”

Phenylephrine was initially approved by the FDA in 1976 based on reports suggesting the drug helped reduce congestion. Note: the overwhelming “evidence” to support this came from a pharmaceutical company that made phenylephrine. But much research since then has shown that this drug does nothing for congestion when taken orally.

Things got a little trickier in 2006, when the Methamphetamine Epidemic Act was signed. This law prohibits the sale of over-the-counter medications containing pseudoephedrine (a decongestant that has been shown to be effective) as well as the amount of pseudoephedrine a person can purchase in a month. This is also why you will be asked to show identification if you wish to purchase a medicine containing pseudoephedrine.

What is behind this law? People were buying pseudoephedrine and using it to make meth.

Because of all these restrictions, phenylephrine has become a more popular decongestant.

Instead of using phenylephrine, consider the following for nasal congestion, e.g. Linda N. Lee, MD., assistant professor of otolaryngology – head and neck surgery at Harvard Medical School and otolaryngologist at Massachusetts Eye and Ear:

  • Zyrtec
  • Nasocort Steroid Nasal Spray
  • Flonase Steroid Nasal Spray

Using saline sprays and elevating your head when you sleep can also help, says Dr. Lee. Elevating the head “is a more natural way to reduce congestion by reducing the heavy blood flow to the nose,” she explains.

Of course, if congestion is a regular problem for you or you’re feeling really uncomfortable, it’s a good idea to see a doctor. They will likely want to give you an assessment and offer personalized advice from there.