FDA to Phase Out Common Decongestant: What You Need to Know
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Get ready for a shake-up in the cold and flu aisle.The Food and Drug Management (FDA) is proposing to remove phenylephrine, a widely used decongestant, from over-the-counter medications. This follows years of research questioning its effectiveness in relieving nasal congestion.
Phenylephrine is a key ingredient in many popular brands, including Sudafed and dayquil. The FDA’s move, announced last month, will likely force manufacturers to reformulate or discontinue these products. This decision comes after years of advocacy from researchers, including those at the university of Florida, who first petitioned the FDA in 2007 and again in 2015 to re-evaluate the drug’s efficacy.
For consumers, this means a shift towards choice congestion relief options. Many will likely turn to pseudoephedrine, a decongestant that’s been available behind the pharmacy counter since a 2006 law aimed at curbing methamphetamine production.
“People walk into the drugstore today and see 55,000 medicines on the shelf and they pick one that is definitely not going to work,” explained Dr. Brian Schroer of the Cleveland Clinic. “You take away that option and it will be easier for them to self-direct toward products that really will help them.”
Why the FDA’s Action Now?
The FDA’s decision follows a unanimous vote last year by federal advisors who concluded that oral phenylephrine medications haven’t demonstrated any notable benefit in relieving nasal congestion. Extensive reviews of recent studies showed phenylephrine to be no more effective than a placebo. Furthermore,re-examination of older studies supporting the drug’s initial approval revealed significant flaws and questionable data.
The FDA’s proposal targets oral phenylephrine medications, a market representing approximately $1.8 billion in annual U.S. sales.Nasal sprays containing phenylephrine remain unaffected, even though they hold a much smaller market share.
The shift away from phenylephrine is partly a consequence of the 2006 law restricting access to pseudoephedrine. This led many manufacturers, including Johnson & Johnson and Bayer, to reformulate their products using phenylephrine, often marketing them as “PE” versions of established brands.
Effective Alternatives for Congestion Relief
Consumers seeking oral decongestants will find pseudoephedrine-based options available behind the pharmacy counter, requiring photo ID verification. Beyond that, a range of over-the-counter nasal sprays and solutions offer effective alternatives.
Saline nasal sprays and rinses provide fast relief by clearing mucus. For longer-term relief from seasonal allergies, doctors frequently enough recommend nasal steroids like Flonase, Nasacort, and Rhinocort. “These medicines are by far the most effective daily treatment for nasal congestion and stuffiness,” Dr. Schroer noted, adding, “The biggest issue is they’re not great when used on an as-needed basis.”
For faster-acting short-term relief, antihistamine nasal sprays such as Astepro are a viable option. phenylephrine-based nasal sprays will remain available.
Why Oral Phenylephrine Fails
Experts attribute the ineffectiveness of oral phenylephrine to its rapid breakdown in the stomach. “This is a good drug, but not when it’s swallowed,” explained Leslie Hendeles, professor emeritus at the University of Florida’s College of Pharmacy. “It’s inactivated in the gut and doesn’t get into the bloodstream, so it can’t get to the nose.”
Phenylephrine’s Ineffectiveness Prompts FDA Review: What it Means for Consumers
Millions of Americans rely on over-the-counter decongestants to alleviate cold and allergy symptoms. A key ingredient in many of these medications, phenylephrine, is now under scrutiny following research revealing its ineffectiveness in treating nasal congestion. This raises important questions about consumer choice and the regulatory process governing over-the-counter medications.
Studies have shown that even significantly increased doses of phenylephrine fail to provide relief from stuffiness. In fact, research indicates that doses 400% higher than the currently recommended levels are still ineffective. This finding prompted the Food and Drug Administration (FDA) and other researchers to express concerns about the potential safety risks associated with higher dosages.
“If you’re using very high doses, the risk is raising blood pressure so high that it could be hazardous to patients,”
explained Randy Hatton, a university of Florida professor who co-led the research on phenylephrine. He further noted that the drug’s cardiovascular effects sometimes lead to its use in treating dangerously low blood pressure during surgical procedures.
The road Ahead: FDA Review and Consumer Impact
While the FDA investigates, oral phenylephrine medications will remain on store shelves for the foreseeable future. The removal of phenylephrine from the list of approved over-the-counter decongestants is a multi-step process. The FDA will accept public comments on its proposal for six months, allowing consumers and pharmaceutical companies to voice their opinions. Following this comment period, the agency will review the feedback and issue a final order. Even after a final decision, manufacturers will likely have over a year to reformulate or remove phenylephrine from their products.
the timeline could be further extended if drug manufacturers request additional hearings. The Consumer Healthcare products Association, representing numerous medicine makers, advocates for maintaining the availability of phenylephrine products, arguing that Americans deserve “the option to choose the products they prefer for self-care.”
“Our position is that choosing from something that doesn’t work isn’t really a choice,”
countered Professor Hatton, highlighting the discrepancy between consumer choice and the scientific evidence regarding phenylephrine’s efficacy.
This situation underscores the importance of evidence-based medicine and the ongoing dialog between regulatory bodies, researchers, and consumers in shaping the availability and use of over-the-counter medications in the United States.
Common Cold Medicine Under Scrutiny: What You Need to Know About the FDA’s Proposed Phenylephrine Ban
The FDA is proposing to remove phenylephrine, a common ingredient in over-the-counter decongestants, from the market due to concerns about its effectiveness. This decision could significantly impact how consumers treat nasal congestion and has sparked debate about the role of science in regulating medications.
A Conversation with Dr. Brian Schroer
Dr. Brian Schroer, a respected allergist and immunologist at the Cleveland Clinic, recently spoke with our Senior Editor about the FDA’s proposal and what it means for consumers.
What Prompted the FDA’s Decision?
Senior Editor: Dr. Schroer, the FDA is taking a bold step in proposing to ban phenylephrine.What led to this decision?
Dr. Schroer: For years, there’s been growing concern among researchers and specialists about the effectiveness of oral phenylephrine.Numerous studies have shown that it simply doesn’t work well to relieve nasal congestion compared to a placebo. The FDA’s action is a response to overwhelming scientific evidence demonstrating its lack of benefit.
What Are the Alternatives for Consumers?
Senior Editor: With phenylephrine potentially being removed from the market, what options will consumers have for congestion relief?
Dr.Schroer: Pseudoephedrine, which is found behind the pharmacy counter, is still a very effective oral decongestant. Beyond that, saline nasal sprays and rinses provide excellent fast-acting relief.For people with allergies, nasal steroid sprays like Flonase or Nasacort are highly effective for long-term management.
Why Doesn’t Oral Phenylephrine Work?
Senior Editor: Many people are surprised to learn that phenylephrine doesn’t work. Why is that?
Dr. Schroer: Oral phenylephrine is rapidly broken down in the stomach. It never reaches the bloodstream in sufficient quantities to effectively reach the nasal passages and provide relief.
What Message Do You Have for Consumers?
Senior Editor: What advice would you give to consumers who are used to relying on phenylephrine-containing products?
Dr. Schroer: I encourage people to talk to thier doctors or pharmacists about the best options for them. There are safe and effective alternatives available. This change is ultimately about empowering consumers with access to medications that truly work.
