FDA advisory panel’s declaration paves way for removal of dozens of medicines in the U.S
Sept. 14, 2023 — America’s most popular oral nasal decongestant, phenylephrine, is not effective and no better than a placebo, an FDA panel said Tuesday.
Phenylephrine — found in drugs like Sudafed PE, Dayquil, Nyquil, Mucinex, Robitussin, and Benadryl Allergy Plus Congestion. This is the most popular oral decongestant in the United States, generating almost $1.8 billion in sales last year.
The drug is thought to relieve congestion by reducing the swelling of blood vessels in the nasal passages.
Phenylephrine gained popularity in the early 2000s as a replacement for pseudoephedrine, the decongestant used in Sudafed, which was moved behind the pharmacy counter in 2006 in an attempt to curb its misuse as an ingredient to make methamphetamine.
The panel’s vote reflects damning evidence provided by the FDA. They found that when taken orally, a very small amount of the drug actually reaches the nose to relieve congestion.
FDA scientists presented the results of five studies conducted over the past two decades. All the studies concluded that the decongestant was no more effective than a placebo.
They also re-evaluated the initial findings used to support its OTC use. They found the results were inconsistent, did not meet modern standards, and may have had data integrity issues.
The FDA will now decide whether to revoke the drug’s designation as “generally recognized as safe and effective.” The designation, allows drugmakers to include an ingredient in OTC products without the need to file an FDA application.
Without the designation, products containing the ingredient may need to be removed from store shelves, or manufacturers may have to develop new formulations.
“In conclusion, we do believe that the original studies were methodologically unsound and do not match today’s standard. By contrast, we believe the new data are credible and do not provide evidence that oral phenylephrine is effective as a nasal decongestant,” said Dr. Peter Starke, an FDA official who led the review of phenylephrine.
The concern goes beyond ineffectiveness; phenylephrine can come with side effects such as headaches, insomnia and nervousness. At higher doses, it can increase blood pressure.
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Source: nbcnews.com nytimes.com fda.gov