The Food and Drug Administration (FDA) is taking the battle over Sudafed and other decongestants to the streets.
The agency announced Thursday that it will allow the public to comment on the recent finding that phenylephrine, the active ingredient in dozens of oral decongestants, simply doesn’t work.
On Tuesday of this week, an FDA advisory panel announced — after examining decades of documentation and clinical trial results — that oral phenylephrine is no better than a placebo at reducing nasal congestion.
The advisory panel’s shocking report is not binding, although the FDA generally sides with the opinion of such panels when determining the safety or effectiveness of drugs.
Nasal sprays containing phenylephrine are unaffected by the ruling and would remain available for over-the-counter (OTC) purchases.
“Many OTC medicines, including phenylephrine, are sold because they have an ingredient that FDA generally recognizes as safe and effective (GRASE) when used as recommended,” the agency said in a news release.
If the FDA sides with their advisory panel, then the agency would issue a proposed order to remove all oral drugs containing phenylephrine from store shelves.
“The public would then have the opportunity to comment on the proposed order. If, after considering the comments, FDA continued to conclude phenylephrine is not effective, the agency would issue a final order … and phenylephrine would no longer be considered GRASE,” the FDA announced.
The FDA, founded over 100 years ago with the passage of the 1906 Pure Food and Drugs Act, must by law allow public comments on its rules.
“FDA routinely allows plenty of time for public input (typically 60 days) and carefully considers these comments when it draws up a final rule,” the agency says on its website. The public can submit comments about any proposed regulations directly to the agency through the mail or online at www.regulations.gov.
Phenylephrine is found in many familiar, brand-name OTC oral preparations, including:
- Sudafed PE
- Alka-Seltzer Plus Severe Cold & Flu Formula
- Mucinex
- Robitussin Peak Cold Nighttime Nasal Relief
- Sinex
- Dayquil
- Benadryl
- Tylenol sinus
- Advil sinus congestion
- Lusonal
- Many store brands such as Equate, Walgreens, CVS, etc.
Phenylephrine first came to prominence in 2006 after another decongestant, pseudoephedrine, was taken off drugstore shelves because it’s an ingredient in the illegal stimulant methamphetamine.
After the passage of the Combat Methamphetamine Epidemic Act of 2005, pseudoephedrine was available only behind the counter, so drugmakers replaced it with phenylephrine-based OTC products.
However, when the FDA panel analyzed the early studies used to support phenylephrine’s OTC use, they found that study results were inconsistent, did not meet modern standards for study design or had flawed data.
“[W]e do believe that the original studies were methodologically unsound and do not match today’s standard,” said Dr. Peter Starke, an FDA official who led the recent review of phenylephrine.
“By contrast, we believe the new data are credible and do not provide evidence that oral phenylephrine is effective as a nasal decongestant,” Starke added.
The market for OTC decongestants is huge: A consumer study of 100,000 US households showed that about half purchased medications with phenylephrine over the course of the year, and most of those did so several times a year.
