These 7 Cold & Flu Medicines Are About to Be Banned by the FDA

These 7 Cold & Flu Medicines Are About to Be Banned by the FDA

Of flu season in full swing, finding effective medications to help bothersome symptoms is the key to sorting it out how to recover faster from the flu. There are plenty 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 getting smaller. The US Food and Drug Administration (FDA) announced that it plans to ban products containing phenylephrine, an ingredient found in many over-the-counter cold and flu medications.

The FDA has announced a proposal to remove oral phenylephrine, found in many popular over-the-counter decongestants, from the shelves. 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 medications 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 in accordance with the advisory committee’s advice, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”

This doesn’t come out of nowhere: Last year, an FDA advisory committee determined that phenylephrine was ineffective. CFS announced after that, it would no longer stock products containing oral phenylephrine, but many other major pharmacies still sell the drugs.

The news raised many questions about phenylephrine and which 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 medication used to relieve nasal congestion caused by colds, allergies, and hay fever. US National Library of Medicine.

The drug is designed to constrict blood vessels, explains Jamie Alan, Ph.D., an associate professor of pharmacology and toxicology at Michigan State University. “If there is congestion, this will constrict the blood vessels in the nose, and less fluid will ‘leak’ out, reducing congestion,” says Alan.

Phenylephrine is an OTC medication.

Which products contain phenylephrine?

There are many. These are some of the most popular products that mention oral phenylephrine:

  • Sudafed PE
  • Vicks DayQuil
  • Mucinex Sinus-Max
  • Theraflu
  • Tylenol sinus
  • Advil congestion
  • NyQuil Severe colds and flu

What does this mean if you have products containing phenylephrine?

From this moment on it means nothing. The proposed ban is not itself related to safety concerns. And the FDA’s ban wouldn’t take effect immediately — if at all. Instead, the proposal will trigger 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), it’s unlikely that the drug will do anything for your stuffy nose, at least based on the phenylephrine alone. (Some of these products contain other ingredients, such as acetaminophen or ibuprofen, that may help you feel better FDA explains.)

What does the evidence say about phenylephrine?

Data has shown that phenylephrine is not effective in relieving congestion. One randomized, placebo-controlled study where 39 people exposed people who are sensitive to grass to grass pollen. They then gave them medications containing phenylephrine, pseudoephedrine (another decongestant), or a placebo. The researchers found that phenylephrine performed about the same as the placebo in relieving congestion.

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

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 Association recently called it a “fake decongestant.”

Phenylephrine was originally approved by the FDA in 1976 based on reports suggesting the drug helped reduce congestion. Worth noting: the overwhelming “proof” to support this was from a pharmaceutical company that made phenylephrine. But numerous studies conducted since then have shown that this drug does nothing for congestion when taken orally.

Things got a little trickier in 2006, when the Combat the Methamphetamine Epidemic Act was signed. This law banned the sale of over-the-counter medications containing pseudoephedrine (a decongestant that has actually been found to be effective) and limited the amount of pseudoephedrine a person can purchase in a month. Therefore, you will also be asked to show proof of identity if you want to buy a medicine containing pseudoephedrine.

What’s behind that law? People were buying pseudoephedrine and using it to make meth.

Due to all the limitations, phenylephrine became 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 nasal steroid spray
  • Flonase nasal steroid spray

Using saline sprays and elevating your head while sleeping can also help, says Dr. Lee. Elevating your head “is a more natural way to relieve congestion by reducing the strong blood flow to the nose,” she explains.

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

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