A popular nasal congestion drug turned out to be useless
The Food and Drug Administration reviewed data on phenylephrine, an ingredient in many popular nasal decongestants in the United States, and found it ineffective when taken orally.After reviewing years of data, the Food and Drug Administration's Over-the-Counter Drugs Advisory Committee (NDAC) concluded that phenylephrine does not help with nasal congestion when taken orally. However, it will relieve nasal congestion when delivered directly to the nose - such as with a nasal spray.
When phenylephrine is taken orally, less than 1% of the drug actually enters the bloodstream and nasal tissues. That said, it is a key ingredient in popular decongestants such as Sudafed PE, Benadryl Allergy Plus Congestion and DayQuil Cold & Flu.
The FDA explained how an ineffective drug ended up among the approved drugs. "Past studies of the drug had inconsistent results and sample sizes that were too small, and they relied on outdated statistical methods and technology that regulators will no longer accept," Dr. Peter Stark, an FDA official who led the review, told the Associated Press.