An advisory panel to the Food and Drug Administration unanimously agreed on Tuesday that phenylephrine, a common decongestant ingredient found in many over-the-counter cold medicines, is ineffective for relieving nasal congestion.
This decision sets the stage for the agency to potentially ban phenylephrine from these products, leading to the removal of hundreds of items from store shelves, including popular brands like Tylenol, Mucinex, and Benadryl cold and flu remedies.
However, it may take several months for the FDA to finalize its decision, and there may be challenges to the findings. This could further delay any product substitutions or removal of stock from stores.
In the meantime, experts recommend that consumers remain calm and avoid discarding all the drugs in their medicine cabinets. While phenylephrine is ineffective for nasal congestion relief when taken orally, it is not considered dangerous. These products still contain other ingredients that can help alleviate cold symptoms.
The panel based their unanimous vote on a review of various studies, which concluded that phenylephrine is essentially useless and no better than a placebo.
Some advisers noted that taking phenylephrine only delays the use of more effective remedies.
“We have better options in the over-the-counter space to help our patients, and the studies do not support that this is an effective drug,” said Maria Coyle, chairwoman of the panel and associate professor of pharmacy at Ohio State University.
Dr. Leslie Hendeles, a pharmacist from the University of Florida, explained, “If you have a stuffy nose and you take this medicine, you will still have a stuffy nose.” He and his colleagues initially petitioned the FDA in 2007 to remove phenylephrine from the market.
Each cold and flu season, millions of Americans rely on at least 250 products containing phenylephrine, which generated nearly $1.8 billion in sales last year. Some examples include Sudafed Sinus Congestion, Tylenol Cold & Flu Severe, NyQuil Severe Cold & Flu, Theraflu Severe Cold Relief, and Mucinex Sinus Max.
These products typically contain two oral decongestants: phenylephrine and pseudoephedrine.
Under previous FDA standards, phenylephrine was considered safe and effective because it constricts blood vessels in the nasal passages. Nasal sprays with phenylephrine are still considered effective, as well as its use in surgery or eye dilation. Nasal sprays containing oxymetazoline are also effective for nasal congestion.
Other options for easing congestion during a cold include products containing oral pseudoephedrine, nasal steroids like Flonase, nasal antihistamines, and oral pseudoephedrine for hay fever or allergic rhinitis.
Many popular cold and flu products not specifically targeting congestion do not contain phenylephrine.
If phenylephrine is removed from these products, it could disrupt the market and potentially lead to increased use of pseudoephedrine, which is restricted due to its misuse in meth labs.
Buying pseudoephedrine products can be a tedious process, as they are kept behind store counters, have purchase limits, and require age verification.
Pseudoephedrine can also cause side effects such as increased blood pressure, jitters, and wakefulness, according to Dr. Hendeles.
The issue of phenylephrine’s effectiveness has been debated at the FDA for decades.
Dr. Hendeles, now an emeritus professor, has been evaluating the ingredient since 1993 and stated, “Quality research has told the true story about phenylephrine.”
The potential benefits of discontinuing phenylephrine use, as suggested by the FDA, include avoiding unnecessary costs and delays in care by not taking a drug without any benefit.
Consumers should not take additional doses of combination cold medicines containing phenylephrine if one dose does not provide relief. Excessive consumption of other ingredients in these products can be dangerous.
The Consumer Healthcare Products Association, representing companies that produce over-the-counter drugs, disagreed with the panel’s recommendation. They claim that phenylephrine is both safe and effective, and removing it would lead to negative consequences.
According to Marcia D. Howard, vice president of regulatory and scientific affairs for the Consumer Healthcare Products Association, removing phenylephrine would burden consumers and strain the U.S. healthcare system.
It may be some time before any changes are announced, but the FDA has already indicated that phenylephrine is ineffective. The agency will consider the comments and opinions of its panel experts before making a final decision.
As is often the case when the FDA proposes regulations that impact major corporations, efforts to delay the decision, such as lawsuits and lobbying, are expected. The agency may also provide a grace period for drug companies to replace ingredients if necessary.
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