FDA Panel Rules That Popular Decongestant Found in Cold Medicines Does Not Work – Benadryl, Sudafed, and Several More Drugs Face Removal from Stores
Most Gateway Pundit readers at some point have used products such as Benadryl and DayQuil to relieve symptoms caused by a cold or the flu. Now these and other popular medicines could soon be unavailable at stores nationwide thanks to a ruling today.
The Associated Press reported that one of the agency’s panels voted unanimously Tuesday against the effectiveness of an ingredient called phenylephrine. As the Daily Mail notes, phenylephrine is the most common active compound in over-the-counter drugs like Benadryl Allergy Plus Congestion, Sudafed PE, and Tylenol Cold and Flu Severe Day & Night.
The drug is also found in Allegra and Dayquil as well.
Oral phenylephrine is broken apart in the gut, which allows the medicine to enter the bloodstream. From there, the drug enters the nose.
The Daily Mail reveals that the FDA put together briefing documents showing that less than a one percent concentration of the phenylephrine is able to reach the nose after being broken down in the gut.
While the ruling is not binding, the Daily Mail reports the agency is likely to heed the panel’s advice and pull its approval of phenylephrine. Should this happen, companies will have to pull Benadryl, Sudafed, and several more drugs from store shelves.
Consumers would be forced to switch to behind-the-counter pills or to nasal sprays and drops that contain phenylephrine. These are not currently not under review.
The Associated Press reported this meeting was prompted by University of Florida researchers who cited recent studies showing that phenylephrine products failed to outperform placebo pills in patients with cold and allergy congestion. Due to this research, they lobbied the FDA to remove the products from store shelves.
The news outlet notes that the researchers previously pressed the FDA to remove phenylephrine products back in 2007 but the agency rebuffed them.
Jennifer Schwartzott, the patient representative on the FDA panel, said the drug in its oral dose should have already been removed.
I feel this drug in this oral dose should have been removed from the market a long time ago. Patients require and deserve medications that treat their symptoms safely and effectively and I don’t believe that this medication does that.
Some will certainly note the irony of the FDA ruling phenylephrine ineffective when they just approved a brand new COVID shot which has questionable efficacy for at least some Americans.