Nationwide Removal Imminent for Ineffective Common Cold Medicines

The FDA panel has unanimously ruled against the effectiveness of phenylephrine, a popular decongestant found in common cold medicines. This decision could potentially lead to the removal of well-known drugs such as Benadryl, Sudafed, and several others from store shelves across the nation.

Phenylephrine is the most prevalent active compound in over-the-counter drugs like Benadryl Allergy Plus Congestion, Sudafed PE, and Tylenol Cold and Flu Severe Day & Night. It’s also present in Allegra and Dayquil.

The drug works by being broken down in the gut, allowing it to enter the bloodstream and subsequently the nose. However, FDA briefing documents reveal that less than one percent concentration of the phenylephrine reaches the nose after this process.

Phenylephrine, a common decongestant in medicines like Sudafed PE or NyQuil Severe Cold & Flu, is no better than a placebo when taken orally, says an FDA advisory panel. https://t.co/Hu80XFJgOi

— The Verge (@verge) September 13, 2023

This ruling was prompted by researchers from the University of Florida who presented recent studies indicating that phenylephrine products failed to outperform placebo pills in patients suffering from cold and allergy congestion.

These findings led them to lobby the FDA to remove these products from store shelves. Interestingly, this isn’t the first time these researchers have attempted to persuade the FDA. They made a similar push back in 2007, but their efforts were rebuffed by the agency.

While the FDA panel’s ruling is not binding, it’s highly likely the agency will heed the panel’s advice and withdraw its approval of phenylephrine.

If this happens, companies will be compelled to pull the affected drugs from store shelves. This would force consumers to switch to behind-the-counter pills or to nasal sprays and drops containing phenylephrine, which are currently not under review.

The FDA would rather you take an experimental vaccine than they would cold medicine.

— Matt Foxhunter (@mfoxhunter) September 13, 2023

Jennifer Schwartzott, the patient representative on the FDA panel, expressed her belief that the drug in its oral dose should have already been removed.

She stated, “Patients require and deserve medications that treat their symptoms safely and effectively, and I don’t believe this medication does that.”

The irony of this situation is not lost on observers. The FDA’s ruling on phenylephrine comes at a time when they just approved a new COVID shot, which raised questions about its efficacy for some Americans.

This development serves as a stark reminder of the importance of rigorous scientific research and regulatory oversight in ensuring the safety and effectiveness of over-the-counter drugs.

It also underscores the need for consumers to stay informed about the medications they use regularly.

This article appeared in The Patriot Brief and has been published here with permission.