LOUISVILLE, Ky. — A key ingredient in most popular decongestants medication has been ruled non-effective by a panel of FDA advisers. 

What You Need To Know

  • 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
  • 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

  •  The FDA says it will review the expert's findings

  • Pharmacists emphasize phenylephrine is still safe to take

Earlier this week the 16-person panel unanimously concluded phenylephrine does not do what it says it does on the label and should not be sold.

The FDA says it will now review the panel’s findings.

Phenylephrine is found in popular versions of Sudafed, Allegra, Dayquil and other medications.

Following this ruling, pharmacists emphasize products containing phenylephrine are still safe to take.

 
 
 
 
Amanda Thurman is a clinical pharmacist with Norton Healthcare in Louisville. (Spectrum News 1/Mason Brighton)

“No, there is no safety concern with taking phenylephrine. It will just not be effective for treating those nasal congestion symptoms,“ Amanda Thurman, a clinical pharmacist with Norton Healthcare said.

Thurman says the efficacy of phenylephrine has been questioned for years. She recommends speaking with your doctor to find an alternative medication that’s right for you.

“Pseudoephedrine can pose risks for certain people with cardiac conditions. So that is where talking to your care provider and or your pharmacist, whether that is safe for you, would be important before moving forward,“ Thurman said. 

Thurman adds typically the FDA takes recommendations from experts seriously. The agency has not given a timeline for when we can expect a decision.

“Next step would be if the FDA chooses to accept that recommendation and then remove those products from the market,” Thurman said.

The common use of drugs containing phenylephrine became widespread after medications containing pseudoephedrine were moved behind pharmacy counters in 2006.

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