Key Ingredient In Over-The-Counter Decongestants Doesn't Work: FDA Advisors

Sudafed and Tylenol sit on the shelf at a Morton Williams Su

Photo: Bloomberg

A panel of advisors for the Food and Drug Administration said that a commonly used drug to treat nasal decongestion doesn't actually work. The drug, phenylephrine, is found in many over-the-counter decongestants, including Sudafed PE, Vicks Nyquil Sinex Nighttime Sinus Relief, and Benadryl Allergy Plus Congestion.

The Nonprescription Drugs Advisory Committee reviewed data from five studies that showed phenylephrine is not an effective treatment for nasal congestion when taken orally. The committee voted unanimously to declare phenylephrine ineffective in treating nasal congestion.

"In conclusion, we do believe that the original studies were methodologically unsound and do not match today's standard. By contrast, we believe the new data are credible and do not provide evidence that oral phenylephrine is effective as a nasal decongestant," said Dr. Peter Starke.

The review only looked at the oral version of phenylephrine and did not make a recommendation on nasal sprays that contain the drug.

The FDA will now review the panel's recommendation and decide whether to revoke the drug's designation as "generally recognized as safe and effective." If it does rescind the designation, the drug would have to be pulled off store shelves.

According to FDA data presented to the panel, drugs containing phenylephrine generated nearly $1.8 billion in sales last year.

Phenylephrine has been in use since the early 2000s as a replacement for pseudoephedrine. While pseudoephedrine is effective at treating congestion, the FDA ordered drugs containing it to be moved behind the counter in 2006 because it can also be used to manufacture methamphetamine.

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