Title: FDA Considers Removing Ingredient from Popular Cold and Flu Medications
Subtitle: Long-debated ingredient’s effectiveness questioned, potential impact on consumers
(Date)
The Food and Drug Administration (FDA) is currently deliberating whether to remove a commonly used ingredient from popular cold and flu medications. The ingredient in question, phenylephrine, has been a staple in medicine cabinets across America for decades. However, recent research and a presentation by the FDA suggest that the ingredient may not be as effective as previously believed.
According to the FDA’s presentation, phenylephrine is present in at least 250 products, generating close to $1.8 billion in sales last year alone. Cold and flu medications such as Sudafed Sinus Congestion, Tylenol Cold & Flu Severe, NyQuil Severe Cold & Flu, Theraflu Severe Cold Relief, Mucinex Sinus Max, and others contain this decongestant.
For years, the ingredient has been considered safe and effective under an outdated agency standard. However, the FDA now questions its efficacy based on recent studies. Other remedies that include phenylephrine often contain more effective medicines as well, indicating that the ingredient may not be the primary reason for their effectiveness.
Despite the FDA’s doubts about phenylephrine, medications targeting sinus and nasal congestion continue to include nasal sprays with phenylephrine, such as Afrin, oral pseudoephedrine like Sudafed, or nasal steroids like Flonase. On the other hand, many popular cold and flu products that do not specifically address congestion do not include the ingredient.
The potential removal of phenylephrine from over-the-counter cold and flu medications could disrupt the market for these products if manufacturers do not have enough time to find suitable replacements. Additionally, this move could lead to a resurgence in the use of pseudoephedrine, an alternative that had been regulated due to its connection with illegal meth labs.
The controversy surrounding phenylephrine has been ongoing for decades, with researchers and experts expressing concerns about its effectiveness. In 2007, a petition was submitted to the FDA by pharmacists at the University of Florida, including Dr. Leslie Hendeles, calling for the removal of the ingredient. The FDA has now concluded that phenylephrine, when taken orally, is “not effective as a nasal decongestant.”
While the FDA believes that eliminating phenylephrine would prevent consumers from using an ineffective product, the Consumer Healthcare Products Association argues that the ingredient is safe and effective. The association believes that removing phenylephrine would burden consumers and strain the healthcare system.
The FDA’s decision on whether to remove phenylephrine from cold and flu medications is still pending. The agency will consider comments and opinions from its panel experts before making a final determination. It is expected that there may be efforts to delay the decision through lawsuits and lobbying from corporations affected by the potential change. The FDA may also provide a grace period for drug companies to replace the ingredient in their products if deemed necessary.
As the future of phenylephrine hangs in the balance, consumers and healthcare providers anxiously await the FDA’s final decision, which could have a significant impact on the cold and flu medication market and the millions of Americans who rely on these products during cold and flu season.