Why it matters: These are popular medicine cabinet staples.
Every cold and flu season, millions of Americans turn to these products, some for decades. According to an agency presentation, the decongestant is found in at least 250 products that generated nearly $1.8 billion in sales last year. Products include: Sudafed Sinus Congestion, Tylenol Cold & Flu Severe, NyQuil Severe Cold & Flu, Theraflu Severe Cold Relief, Mucinex Sinus Max and others.
The ingredient has long been considered safe and effective under an old, outdated regulatory standard, and the FDA still says it is safe.
Many medicines that contain phenylephrine also contain other, more effective medicines.
Medications considered effective for sinus infections and nasal congestion still include phenylephrine nasal sprays such as Afrin, oral pseudoephedrine such as Sudafed, or nasal steroids such as Flonase.
Many popular cold and flu products that do not specifically treat congestion do not contain this ingredient.
And it is still widely considered effective when used in surgery and to dilate the eyes. However, scientists have concluded that it is destroyed in the intestines.
If the agency decides that the decongestant should be removed from products, it could significantly disrupt the market for cold medicine makers if they don’t have enough time to replace it in popular items.
What’s more, it could potentially renew the widespread use of an alternative, pseudoephedrine, which has been placed behind counters or in locked cabinets because it was commonly used in illegal meth labs.
Background: Researchers have been trying to get rid of this ingredient for years.
This problem has been simmering at the FDA for decades. In 2007, Dr. Leslie Hendeles and several other University of Florida pharmacists asked the authority to withdraw the drug from the market.
Dr. Hendeles, now a professor emeritus, said in an interview Tuesday that he has been evaluating the ingredient since 1993.
“The bottom line is that high-quality research has told the real story about phenylephrine,” he said.
The FDA has now officially concluded that phenylephrine is “not effective as a nasal decongestant” when taken orally.
The potential benefits to consumers of ceasing use of the ingredient, the agency said, include avoiding unnecessary costs or delays in treatment caused by “taking a drug that provides no benefit.”
The Consumer Healthcare Products Association, which represents companies that make over-the-counter medicines, disagreed, saying in a statement that the ingredient was safe and effective. The organization said eliminating the ingredient would result in the “negative unintended consequences” of patients being sent to doctors and pharmacists for problems they would otherwise treat themselves – or receiving no treatment at all.
“Simply put, the burdens created by reduced choice and availability of these products would be placed directly on consumers and an already strained U.S. health care system,” said the statement from Marcia D. Howard, the U.S. vice president for regulatory and science Group Affairs.
What’s next: It’s up to the FDA to withdraw the ingredient.
It may take a while for changes to be announced.
But the authority has already made its mark by declaring the ingredient ineffective. But now FDA officials will consider the comments and opinions of their panel experts before preparing a final decision.
As is often the case when the FDA wants to push through a regulatory move that will impact the bottom lines of large companies, there will likely be attempts to delay a decision, including lawsuits and lobbying in Congress and the White House. If necessary, the authority can also give pharmaceutical companies a deadline to replace ingredients in products.