The FDA is moving to phase out the decongestant phenylephrine found in many over-the-counter cold medicines due to its ineffectiveness in relieving nasal congestion.
Examples of medications that contain phenylephrine include Sudafed and Dayquil, but experts have long doubted its efficacy in treating congestion.
The big picture: The FDA proposed revoking phenylephrine’s use in tablets and liquid solutions, which may lead to drugmakers reformulating or removing products containing the decongestant.
- Researchers at the University of Florida had petitioned the FDA in 2007 and 2015 to reevaluate the use of phenylephrine, and now their efforts have led to the proposed phase-out.
- Consumers will likely have to switch to alternatives, with an older decongestant that was moved behind pharmacy counters nearly 20 years ago being one of the options.
- Doctors believe that eliminating phenylephrine will help consumers make better choices when selecting medications that truly provide relief.
- Studies have shown that phenylephrine lacks efficacy in relieving nasal congestion when taken orally and is no more effective than a placebo.
Go deeper: While the drug remains effective in nasal sprays, oral versions have not shown significant benefits in clearing nasal passageways.
- Pseudoephedrine-containing products like Sudafed and Claritin D, available behind pharmacy counters, are alternatives for those seeking relief from congestion.
- Other over-the-counter options for congestion relief include nasal sprays, saline drops, and nasal steroids like Flonase, Nasacort, and Rhinocort for long-term relief.
- Daily use of nasal steroids is considered the most effective treatment for congestion, while antihistamine sprays like Astepro provide faster relief for short-term symptoms.
- Despite phenylephrine’s continued availability in nasal sprays, oral ingestion renders the drug ineffective due to quick breakdown in the stomach.