Sudafed, Benadryl, Robitussin donât work, FDA advisory panel suggests
A Food and Drug Administration advisory panel said Tuesday that many over-the-counter decongestants don’t work.
The FDA panel found that phenylephrine — the active ingredient in Sudafed, Benadryl, Robitussin and other popular decongestants — doesn’t reduce nasal congestion. It was noted, however that nasal sprays containing phenylephrine are not impacted by the findings.
“This drug and this oral dose should have been removed from the market a long time ago,” Jennifer Schwartzott, a patient advocate from New York, told NBC News.
Some suggest the panel’s findings may lead to certain products being pulled off store shelves nationwide.
“The patient community requires and deserves medications that treat their symptoms safely and effectively and I don’t believe that this medication does,” Schwartzott added.
According to The Post, recent studies found that phenylephrine didn’t reduce nasal congestion much more than a placebo.
“In conclusion, we 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 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.”
Mark Heim is a reporter for The Alabama Media Group. Follow him on Twitter @Mark_Heim. He can be heard on “The Opening Kickoff” on WNSP-FM 105.5 FM in Mobile or on the free Sound of Mobile App from 6 to 9 a.m. daily.