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These 7 cold and flu medications are about to be banned by the FDA
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These 7 cold and flu medications are about to be banned by the FDA

With flu season in full swing, finding effective medications to help with troubling symptoms is essential to finding out how to recover faster from the flu. There are a lot of 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 shrink. US Food and Drug Administration (FDA) announced that it plans to ban products containing phenylephrine, an ingredient found in many over-the-counter (OTC) oral cold and flu medications.

The FDA has announced a proposal to remove from the shelves oral phenylephrine, which is found in many popular OTC decongestants. The reason for the ban is that the ingredient is simply not effective, the FDA says.

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 – Head and Neck Surgery at Harvard Medical School and an otolaryngologist at Massachusetts Eye and Ear

“The FDA’s role is 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 the available data and consistent with the advisory committee’s opinion, we are taking the next step in the process of proposing to eliminate oral phenylephrine because it is not effective as a nasal decongestant.”

This is not out of nowhere: Last year, an FDA advisory committee determined that phenylephrine was ineffective. CVS announced after that, it will no longer stock products that contained oral phenylephrine, but many other major pharmacies still sell the drugs.

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

What is phenylephrine?

Phenylephrine is a drug that has been used to relieve nasal congestion caused by colds, allergies, and hay fever, according to US National Library of Medicine.

The drug is designed to constrict blood vessels, he explains Jamie Alan, Ph.D., associate professor of pharmacology and toxicology at Michigan State University. “In congestion, this will constrict the blood vessels in the nose and there will be less ‘leakage’ of fluid, thus relieving congestion,” says Alan.

Phenylephrine is an OTC drug.

What products contain phenylephrine?

There are many. These are some of the more popular products that list oral phenylephrine:

  • Sudafed PE
  • Vicks DayQuil
  • Mucinex Sinus-Max
  • Theraflu
  • Sinus Tylenol
  • Congestion Advil
  • NyQuil Severe Cold and Flu

What does this mean if you have products containing phenylephrine?

As of this second, it means nothing. The proposed ban has nothing to do with safety issues, per se. And the FDA ban wouldn’t take effect immediately — if at all. Instead, the proposal will launch a six-month public comment period. After that, the FDA will make a final decision on whether to remove the phenylephrine-containing products.

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, such as acetaminophen or ibuprofen, which may help you feel better, FDA explain.)

What does the evidence say about phenylephrine?

The data showed that phenylephrine does not work to relieve congestion. One randomized, placebo-controlled study with 39 people exposed to grass sensitizers to grass pollen. They then gave them drugs containing either phenylephrine, pseudoephedrine (another decongestant), or a placebo. The researchers found that phenylephrine was about as effective as placebo in relieving congestion.

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

Why was phenylephrine approved in the first place?

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

Phenylephrine was originally approved by the FDA in 1976 based on reports that suggested the drug helped reduce congestion. Of note: the overwhelming “EVIDENCE” to support this was from a drug company that produced phenylephrine. But much research since then has found that this drug does nothing for congestion when taken by mouth.

Things got a little stickier in 2006 when The Act to Combat the Methamphetamine Epidemic was signed. This law prohibited the sale of over-the-counter drugs containing pseudoephedrine (a decongestant that has actually been shown to be effective) and the amount of pseudoephedrine a person could buy in a month. You will also be asked to show ID if you want to buy a medicine that contains pseudoephedrine.

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

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

Instead of using phenylephrine, consider the following for nasal congestion, per Linda N. Lee, MD., an assistant professor of Otolaryngology – Head and Neck Surgery at Harvard Medical School and an 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 heavy blood flow to the nose,” she explains.

Of course, if congestion is a regular problem for you. or if you feel really uncomfortable, it’s a good idea to contact a doctor. They’ll probably want to give you an assessment and give you personalized guidance from there.