FDA to Phase Out Ineffective Phenylephrine, Shifting Focus to Reliable Cold Remedies

December 23, 2024
FDA to Phase Out Ineffective Phenylephrine, Shifting Focus to Reliable Cold Remedies
  • U.S. officials are taking steps to phase out phenylephrine, a common decongestant in over-the-counter medications, after determining it does not effectively relieve nasal congestion.

  • This decision follows a unanimous vote by federal advisers in 2023, which was influenced by recent studies and earlier flawed research from the 1960s and 1970s.

  • Despite the impending changes, current regulations allow oral phenylephrine medications to remain available during a lengthy review process that includes public comment and potential product reformulation.

  • Experts explain that phenylephrine is ineffective when taken orally because it is rapidly broken down in the stomach, preventing it from entering the bloodstream.

  • Phenylephrine became the go-to decongestant after pseudoephedrine was moved behind pharmacy counters in 2006 due to its potential misuse in methamphetamine production.

  • Experts maintain that ineffective options like phenylephrine do not constitute real choices for consumers, despite arguments from industry advocates.

  • Concerns about phenylephrine's efficacy have been raised since 2007 by researchers, including those from the University of Florida, prompting petitions to the FDA in 2007 and 2015.

  • Doctors believe that eliminating phenylephrine will help consumers choose more effective alternatives for treating cold, flu, fever, and allergies.

  • Even higher doses of phenylephrine have proven ineffective and could pose safety risks, such as elevated blood pressure.

  • The Consumer Healthcare Products Association argues for the continued availability of phenylephrine, claiming consumers should have access to all products, even those that may not be effective.

  • Nasal steroids like Flonase and Nasacort are recommended for long-term relief, but they require daily use, while antihistamine sprays can offer quicker short-term relief.

  • The FDA's actions represent a significant victory for researchers who have long questioned the effectiveness of phenylephrine.

Summary based on 11 sources


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