Nasal decongestant used by millions ‘doesn’t work,’ U.S. FDA advisors say

Advisors to the FDA voted unanimously on Tuesday against the effectiveness of the key drug found in popular versions of Sudafed, Allegra and other medications.

The leading decongestant used by millions of Americans looking for relief from a stuffy nose is no better than a dummy pill, according to government experts who reviewed the latest research on the long-questioned drug ingredient.

Advisers to the Food and Drug Administration voted unanimously on Tuesday against the effectiveness of the key drug found in popular versions of Sudafed, Allegra, Dayquil and other medications stocked on store shelves.

“Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine,” said Dr. Mark Dykewicz, an allergy specialist at the Saint Louis University School of Medicine.

The FDA assembled its outside advisers to take another look at phenylephrine, which became the main drug in over-the-counter decongestants when medicines with an older ingredient — pseudoephedrine —were moved behind pharmacy counters. A 2006 law had forced the move because pseudoephedrine can be illegally processed into methamphetamine.

Those original versions of Sudafed and other medicines remain available without a prescription, but they’re less popular and account for about one-fifth of the $2.2 billion market for oral decongestants. Phenylephrine versions — sometimes labeled “PE” on packaging — make up the rest.

If the FDA follows through on the panel’s recommendations, Johnson & Johnson, Bayer and other drugmakers could be required to pull their oral medications containing phenylephrine from store shelves. That would likely force consumers to switch to the behind-the-counter pseudoephedrine products or to phenylephrine-based nasal sprays and drops.

In that scenario, the FDA would have to work with drugstores, pharmacists and other health providers to educate consumers about the remaining options for treating congestion, panelists said Tuesday.

The group also told the FDA that studying phenylephrine at higher doses was not an option because it can push blood pressure to potentially dangerous levels.