The leading decongestant used by millions of people seeking relief from stuffy noses is no better than a placebo, according to government experts who reviewed the latest studies on the substance in question.
Advisors to the US Food and Drug Administration voted unanimously Tuesday against the effectiveness of the main drug found in popular versions of Sudafed, Dayquil and other drugs available on store shelves. .
“Modern studies, if done well, do not show improvement in congestion with phenylephrine,” said Dr. Mark Dykewicz, an allergist at Saint Louis University School of Medicine.
The FDA brought together outside advisers to take another look at phenylephrine, which became the leading over-the-counter decongestant drug when drugs containing an older ingredient – pseudoephedrine – began to be sold only by prescription. . A 2006 law requires this because pseudoephedrine can be illegally converted into methamphetamine.
Those original versions of Sudafed and other drugs are still available without a prescription, but they are less popular and account for about a fifth of the $2.2 billion market for oral decongestants. Versions containing phenylephrine, sometimes labeled “PE” on the packaging, make up the rest.
If the FDA follows the panel’s recommendations, Johnson & Johnson, Bayer and other manufacturers could be forced to remove oral medications containing phenylephrine from the shelves. This forces consumers to use over-the-counter products that contain pseudoephedrine or sprays and nasal drops that contain phenylephrine.
In that case, the FDA should work with pharmacies, pharmacists and other health care professionals to inform consumers about remaining options for treating congestion, group members said Tuesday.
The group also told the FDA that studying phenylephrine at higher doses was not an option because it could raise blood pressure to dangerous levels.