The FDA will review whether phenylephrine, a common decongestant, truly works to relieve nasal congestion.
The Food and Drug Administration (FDA) is set to re-assess the effectiveness of phenylephrine, a widely used ingredient in over-the-counter decongestants, including Sudafed PE and Vicks Sinex. Despite being approved for use in the 1970s, phenylephrine’s ability to relieve nasal congestion has been questioned by many doctors and pharmacists.
A two-day meeting with an FDA advisory panel next week will focus specifically on the oral formulations of phenylephrine, as opposed to nasal sprays. If the panel concludes that phenylephrine is ineffective when taken orally, the FDA could revoke its status as a “Generally Recognized as Safe and Effective” ingredient, potentially leading to its removal from store shelves. This designation allows drugs containing phenylephrine to be sold without a detailed FDA application process.
Experts, including allergists and primary care physicians, have long criticized the oral form of phenylephrine for its lack of effectiveness. Dr. Purvi Parikh, an allergist, stated that oral phenylephrine “should almost never be used,” and many doctors refrain from prescribing it. As the review continues, patients may soon see significant changes in the availability of medications containing the ingredient.
