FDA may pull popular allergy drugs off the market


An FDA advisory panel says the active ingredient doesn’t really work

Millions of Americans use over-the-counter (OTC) allergy medication to treat stuffy noses but a Food and Drug Administration (PDA) panel recommends that these drugs be pulled from the market.

The panel of scientists said the active ingredient in these medications, phenylephrine, is not effective against allergy symptoms.

The FDA is not required to follow an advisory panel’s recommendation but it usually does. As a result, medications such as Benadryl Allergy Plus Congestion, Sudafed PE, and Tylenol Cold and Flu Severe Day & Night could disappear from store shelves.

Following a two-day conference, panel members said their findings show the pills are not effective at treating allergy symptoms compared to a placebo, either at standard or high dosages.

While the drugs could disappear, experts say it is more likely that drug companies like Johnson & Johnson and Beyar would reformulate them to meet FDA approval. According to information presented to the advisory panel, sales of these drugs produced almost $1.8 billion in sales in 2022.

These drugs have been around for a while

Phenylephrine has been in Americans’ medicine cabinets for a long time. The FDA approved it in the 1970s to shrink the dilated blood vessels in the nose, relieving nasal and sinus congestion.

Some scientists have since questioned its effectiveness because of the way the body metabolizes the drug. However, they say the drug might be effective if taken in ways other than orally.

In what may have been the deciding factor for the panel, the research they reviewed suggests as little as 1% of the drug actually reaches the nose after it is metabolized in the stomach.

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