Oral Decongestants Under Fire
Cold and flu season is making its rounds again and some of the products that may have provided relief in the past have come under scrutiny. Dr. Aaron Workman, a patient favorite at one of the highest rated auto injury medical clinics in Lexington, Kentucky, brings to light the recent concerns regarding oral decongestants. Many people turn to over-the-counter cold and allergy medications containing the nasal decongestant phenylephrine. We have used these different decongestants for years in our household and I have never questioned their efficacy. Unfortunately, a recent unanimous vote by a panel of advisors to the Food and Drug Administration (FDA) has called into question just how well this common ingredient works in popular medications such as Nyquil, Benadryl, Sudafed, and Mucinex.
The advisor’s decision highlights the ineffectiveness of oral phenylephrine (this is the pill form) in relieving a stuffy nose. They have noted too much of the pill form is broken down in the body and does not reach the nose for relief. While the FDA typically follows the guidance of its advisory committees, there are instances where it does not. This has not happened yet with oral phenylephrine but should be watched.
This could impact the manufacturers of Nyquil, Tylenol, and Benadryl products. Retail and pharmacy stores may miss out on the popular decongestant profits if the decision is made to pull the medicines. Information from FDA reveals that retail stores in the U.S. sold 242 million bottles of drugs containing phenylephrine last year, which was an increase from 2021. These sales generated substantial revenue.
The recent advisory meeting was prompted by researchers at the University of Florida, who petitioned the FDA to eliminate phenylephrine products. Their request was based on studies that demonstrated the inability of phenylephrine to outperform placebo pills in patients with cold and allergy congestion. The data shows the ineffectiveness of the oral medications at regular dosing and even higher dosing. These documents suggested that only a small amount, if any, of the drug reaches the nasal passages to provide congestion relief. Since it is labeled as a decongestant the product needs to change in the oral form.
Next the FDA will look over the details of the advisory meeting and their recommendations. In the end this will drive the use of phenylephrine containing over-the-counter medications. If oral phenylephrine is removed from the market, it could mark a large shift in the landscape of cold and allergy relief products. Patients may need to explore alternative options, including liquid and spray versions, to address nasal congestion effectively.
This decision could have impacts across the industry and the FDA’s final determination will change from that point forward in how these medications are used to combat nasal congestion. Patients should keep this in mind in choosing particular decongestants this cold and flu season as previous favorites may eventually become unavailable or reformulated. If you typically purchase nasal sprays or liquid forms of the decongestant, you should still be able to purchase those for now.
— This article is written by Aaron Workman, DC, one of the members of Chambers Medical Group’s team of car accident chiropractors who offer a variety of treatments and therapies ranging from diagnostic testing to various soft tissue therapies for car accidents and injuries in Kentucky.
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