FDA to phase Out Ineffective Cold Medicine: What You Need to Know
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Get ready for a shake-up in the cold adn flu aisle. The U.S. Food and Drug administration (FDA) is proposing to remove phenylephrine, a common decongestant found in numerous over-the-counter medications, due to a lack of evidence supporting its effectiveness in relieving nasal congestion. This decision follows years of scrutiny and research questioning the efficacy of oral phenylephrine.
Phenylephrine, a key ingredient in many popular brands like sudafed and Dayquil, has been under the microscope for some time.The FDA’s formal proposal to revoke its status as a generally recognized as safe and effective (GRASE) ingredient for oral use signals a critically important shift in the treatment of cold and allergy symptoms. This action will likely force manufacturers to reformulate or remove phenylephrine from their products.
This move is a victory for researchers who have long voiced concerns about phenylephrine’s efficacy. Studies dating back to the 1960s and 70s, initially cited to support its use, have been re-evaluated and found to contain significant flaws. More recent, large-scale studies have consistently shown that oral phenylephrine is no more effective than a placebo in relieving nasal congestion.
The impact on consumers will be a shift towards choice treatments. Doctors suggest that Americans will ultimately benefit from the removal of an ineffective ingredient. “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.”
The Rise and Fall of Phenylephrine
Before phenylephrine became the dominant decongestant,pseudoephedrine held that position. However,the Combat Methamphetamine Epidemic Act of 2005 mandated that pseudoephedrine be sold behind the pharmacy counter due to its potential use in methamphetamine production.This led to many manufacturers reformulating their products with phenylephrine, ofen marketing them as “PE” versions of familiar brands.
What Are the Alternatives?
Consumers seeking relief from nasal congestion now have several options. Pseudoephedrine-based products remain available over the counter at pharmacies, but require photo identification for purchase. For those seeking non-oral solutions, nasal sprays offer a viable alternative. Saline solutions provide quick relief, while nasal steroids like Flonase, Nasacort, and Rhinocort offer longer-term relief from seasonal allergies. Dr. Schroer notes, “These medicines are by far the most effective daily treatment for nasal congestion and stuffiness,” but adds, ”The biggest issue is they’re not great when used on an as-needed basis.”
Antihistamine nasal sprays, such as Astepro, provide faster-acting relief for short-term needs. Importantly, phenylephrine nasal sprays will remain available.
the key takeaway from the experts is that phenylephrine’s effectiveness is significantly diminished when ingested. As Leslie Hendeles, professor emeritus at the university of florida, succinctly stated, “This is a good drug, but not when it’s swallowed.”
Phenylephrine Under FDA Scrutiny: Is Your Cold Medicine Effective?
The effectiveness of phenylephrine, a common ingredient in over-the-counter decongestants, is under intense scrutiny by the Food and Drug Administration (FDA).Research suggests the ingredient may be ineffective at treating nasal congestion, prompting a potential removal from the market.
Studies have shown that phenylephrine, even at significantly higher doses, fails to alleviate nasal stuffiness. A University of Florida professor, Randy Hatton, who co-led research on the ingredient, explains the issue: “If you’re using very high doses, the risk is raising blood pressure so high that it could be hazardous to patients.”
This finding is supported by research conducted at a prominent College of Pharmacy,where studies indicated that phenylephrine “is inactivated in the gut and doesn’t get into the bloodstream,so it can’t get to the nose.” This means the drug doesn’t reach the nasal passages to provide relief, rendering its use in decongestants questionable.
While initially, researchers suggested a higher dose might improve efficacy, subsequent studies disproved this theory. The FDA and independent researchers concur that increasing the dosage carries unacceptable safety risks due to the drug’s impact on blood pressure. ironically, phenylephrine’s cardiovascular effects are sometimes utilized medically to treat dangerously low blood pressure during surgical procedures, as noted by Professor Hatton.
The Road to Removal: A Lengthy process
The removal of phenylephrine from FDA-approved over-the-counter decongestants is a complex, multi-stage process. The FDA will accept public comments on its proposal for six months, allowing consumers and pharmaceutical companies to voice their opinions.following this period, the agency will review the feedback and issue a final order. Even after the final decision, manufacturers will likely have over a year to reformulate or remove phenylephrine from their products.
Further delays are possible if drug manufacturers request additional FDA hearings. The Consumer Healthcare Products Association, representing numerous medicine makers, advocates for maintaining the availability of phenylephrine-containing products, arguing that Americans deserve “the option to choose the products they prefer for self-care.” Though, Professor Hatton and his colleagues strongly disagree, stating, “Our position is that choosing from something that doesn’t work isn’t really a choice.”
This ongoing review highlights the importance of informed consumer choices and the FDA’s commitment to ensuring the safety and efficacy of over-the-counter medications. The outcome of this process will significantly impact the cold and allergy medication market in the United states.
FDA to Remove Ineffective Decongestant: What Consumers Should Know
The U.S. Food and Drug Management (FDA) is proposing to remove phenylephrine, a common ingredient in many over-the-counter cold and allergy medications, due to a lack of evidence supporting its effectiveness as a nasal decongestant. This decision follows years of research questioning its efficacy and could lead to notable changes in the cold and flu aisle.
Senior Editor of world-today-news.com, sarah Jennings, sat down with Dr. Michael Thompson, a board-certified pharmacologist and expert on over-the-counter medications, to discuss the implications of this groundbreaking proposal.
Why is the FDA Considering Removing Phenylephrine?
Sarah Jennings: Dr.Thompson, thank you for joining us today.The FDA’s proposal to remove phenylephrine from over-the-counter decongestants has generated a lot of buzz. can you shed some light on the reasons behind this decision?
Dr. Michael Thompson: Absolutely, Sarah. The FDA’s primary concern is ensuring the safety and efficacy of medications available to the public. After reviewing extensive research, including large-scale clinical trials, the FDA concluded that there isn’t sufficient evidence proving that oral phenylephrine effectively relieves nasal congestion.
Many studies dating back decades have shown inconsistent results, and recent research has highlighted serious flaws in the methodologies used to initially support its use. Essentially, the science no longer supports the claim that swallowing phenylephrine effectively reduces stuffiness.
What Does This Mean for Consumers?
Sarah Jennings: This is definitely a significant shift for consumers who rely on these medications. What are some of the alternative options available?
Dr. Michael Thompson: This is an opportunity for consumers to explore more evidence-based options for relieving nasal congestion.
Pseudoephedrine: This is a proven decongestant, but because of its potential for misuse in illegal methamphetamine production, it’s kept behind the pharmacy counter and requires identification.
Nasal Sprays: These offer a direct route to the nasal passages. Saline solutions provide quick relief, while nasal steroids like Flonase, Nasacort, and Rhinocort are effective for long-term allergy symptoms.
* Antihistamine Nasal sprays like Astepro provide faster relief for short-term congestion.
Sarah Jennings: Are there any downsides to these alternatives?
Dr. Michael Thompson: Nasal sprays, while effective, might not be suitable for everyone, and some people experience a temporary stinging sensation. It’s important to consult with your doctor or a pharmacist to determine the best option for your needs.
Sarah Jennings: What about phenylephrine nasal sprays? Will those still be available?
Dr. Michael Thompson: Yes, those will likely remain on the market. The FDA’s concern is primarily with the oral form of phenylephrine.
Looking Ahead
Sarah Jennings: Dr. Thompson, what is your overall outlook on this FDA proposal?
dr.Michael Thompson: I believe this is a positive step towards ensuring that consumers have access to truly effective medications. It’s important to rely on scientific evidence when making decisions about our health. While change can be tough, ultimately, I believe this move will lead to better outcomes for people seeking relief from nasal congestion.
Sarah Jennings: Thank you for your insights, Dr.Thompson. This conversation has certainly provided our readers with valuable information about this important topic.
