The Food and Drug Administration (FDA) is taking steps to ban phenylephrine, a common ingredient in over-the-counter decongestants, citing its ineffectiveness when taken orally.
At a Glance
- FDA advisory panel concludes phenylephrine is ineffective for nasal congestion relief when taken orally
- Decision could impact $1.8 billion market for OTC cold and allergy remedies
- Phenylephrine is found in popular drugs like Sudafed PE, Vicks Nyquil Sinex, and Benadryl Allergy Plus Congestion
- FDA may revoke phenylephrine’s OTC designation as “generally recognized as safe and effective”
- Alternatives include pseudoephedrine, nasal sprays, and saline solutions
FDA Panel Finds Phenylephrine Ineffective
An FDA advisory panel has determined that phenylephrine, a common ingredient in many over-the-counter cold and allergy medications, is ineffective for nasal congestion relief when taken orally. The decision could significantly impact the market for OTC cold and allergy remedies, as many consumers prefer pills over nasal sprays.
Phenylephrine is found in popular drugs like Sudafed PE, Vicks Nyquil Sinex, and Benadryl Allergy Plus Congestion. Sales of these products reached nearly $1.8 billion last year. The FDA may now revoke phenylephrine’s OTC designation as “generally recognized as safe and effective,” potentially leading to its removal from store shelves.
FDA to pull common but ineffective cold medicine from market https://t.co/9o2J6pYmiD
— CBS News (@CBSNews) November 11, 2024
History and Effectiveness of Phenylephrine
Phenylephrine became popular in the early 2000s as a substitute for pseudoephedrine, which was restricted due to its misuse in methamphetamine production. However, FDA studies over two decades found oral phenylephrine no more effective than a placebo, with initial supporting studies deemed methodologically unsound.
According to public health specialist Susan Blalock, the evidence is “pretty compelling that this medication is not effective. I don’t think additional data are needed to support that conclusion.”
Phenylephrine can cause side effects like headaches, insomnia, and increased blood pressure at higher doses. The panel does not question the effectiveness of phenylephrine in nasal spray form.
The Consumer Healthcare Products Association argued that removing oral phenylephrine would burden consumers, citing a survey showing high usage and preference for oral decongestants. However, advisory committee members noted that pseudoephedrine remains an effective alternative, though it requires a request from a pharmacist.
“‘We do have an effective alternative in pseudoephedrine,'” Dr. Maryann Amirshahi said.
The FDA must follow a public process to remove phenylephrine from approved over-the-counter drugs, which could take over a year. This decision is supported by researchers, including those from the University of Florida, who have questioned the drug’s effectiveness since 2007.
Other alternatives for congestion relief include over-the-counter nasal sprays, saline drops, nasal steroids, and antihistamine sprays. Phenylephrine is ineffective orally because it is broken down in the stomach and doesn’t reach the bloodstream.
And the Democrats tell us to follow the science. Don’t they see how often the scientists get things wrong?