Recent FDA findings highlight that a major ingredient in popular cold fighters, phenylephrine, may not offer genuine relief.
Each year, as temperatures drop and sniffles spread, Americans turn to their trusted cold remedies, creating a $40 billion industry. But recent FDA findings have brought to light a sobering fact: a major ingredient in our go-to cold fighters might be more smoke and mirrors than genuine relief.
Enter phenylephrine, a potent vasoconstrictor that's been a mainstay in our OTC cold remedies for decades. Old studies hailed its abilities to clear nasal congestion. Fast-forward to 2023, and an FDA Advisory Committee has sounded the alarm bell: when taken orally, phenylephrine doesn't do the job.
How did we get here? A mixture of legacy, regulations, and a thirst for market share has kept phenylephrine center stage. Originally, this drug was grandfathered onto our shelves, even before the FDA started regulating drug efficacy.
When regulations in the 2000s pushed competitors such as pseudoephedrine behind the pharmacy counter, phenylephrine's unrestricted status made it manufacturers' favorite. It's an irony that an industry built around alleviating discomfort relied on such discomforting truths.
By 2007, the FDA had expressed reservations. The research was, at best, inconclusive. Yet, it was only in 2023 that the final verdict arrived: phenylephrine, when consumed orally, wasn't up to the mark. Now, we're faced with a dilemma: what do we do with a drug that's entrenched in our OTC landscape but fails the efficacy test?
Beyond this revelation, there's another pressing concern: patient safety. With adverse effects such as heart palpitations and insomnia, can we justify phenylephrine's place in our medicine cabinet? There's a silver lining, however.
In our quest for relief, we've stumbled upon a chance to innovate. It's high time we revitalized the cold remedy market, which hasn't seen groundbreaking changes in half a century. Some pioneers are already showing the way, with repurposed molecules that may reduce cold severity and duration by remarkable margins.
In rethinking our approach to the common cold, we have a golden opportunity: to harness new insights, to innovate, and to deliver real relief to millions. After all, isn't that what medicine is all about?
About the Author
Jackie Iversen, RPh, MS, co-founder and chief clinical officer, Sen-Jam Pharmaceutical.