FDA Declares Common Cold Medicine Ingredient Ineffective

FDA Declares Popular Decongestant Ineffective: What You Need to Know

Changes are coming to the cold and cough medicine aisle at your local pharmacy. The U.S. Food and Drug Administration (FDA) is phasing out phenylephrine, the primary decongestant found in many over-the-counter (OTC) cold medications, as it doesn’t effectively relieve nasal congestion.

What’s Happening?

Phenylephrine is an active ingredient in well-known products like Sudafed, DayQuil, and others. While widely used, its effectiveness has been questioned for years. The FDA recently proposed revoking its use in pills and liquid medications, a decision that could lead drugmakers to either reformulate or discontinue affected products.

This decision is a win for researchers and academics, including University of Florida experts who have been urging the FDA to revisit the drug’s approval since 2007.

For consumers, the phase-out means a shift toward alternatives, such as the older decongestant pseudoephedrine, which has been restricted to behind-the-counter sales since 2006 due to its potential use in methamphetamine production.

Why Does Phenylephrine Fall Short?

Studies show that phenylephrine is ineffective when taken orally because it’s quickly broken down in the stomach, preventing it from entering the bloodstream and reaching the nasal passages.

“This is a good drug, but not when it’s swallowed,” explained Leslie Hendeles, professor emeritus at the University of Florida. Even increasing the dosage to 400% of the current recommendation failed to alleviate nasal congestion, and higher doses could pose serious risks, such as dangerously elevated blood pressure.

Why Now?

The FDA’s decision follows unanimous recommendations from federal advisors last year. These advisors reviewed recent large-scale studies as well as older research from the 1960s and 1970s, identifying numerous flaws in the earlier data that supported phenylephrine’s approval.

While phenylephrine nasal sprays remain effective, they are far less popular than pills and syrups, which account for an estimated $1.8 billion in annual U.S. sales.

What Are the Alternatives for Congestion Relief?

Here’s what you can consider:

Behind-the-Counter Options:
- Medications with pseudoephedrine, such as Sudafed and Claritin-D, are available without a prescription but require a photo ID for purchase.
Nasal Sprays and Rinses:
- Saline Drops/Rinses: Quickly clear mucus and relieve congestion.
- Nasal Steroids: Products like Flonase, Nasacort, and Rhinocort provide effective long-term relief for seasonal congestion and allergies. These must be used daily for optimal results.
- Antihistamine Sprays: Fast-acting sprays like Astepro work well for short-term relief.
Phenylephrine Sprays: These remain available and effective for immediate nasal relief.

What’s Next?

Phenylephrine-based oral medications will remain on shelves for now. The FDA must undergo a public process to remove the drug from its list of approved OTC ingredients. This includes a six-month period for comments from consumers and manufacturers, followed by additional review.

Even after the FDA finalizes its decision, drugmakers will likely have over a year to reformulate or discontinue their products. Manufacturers could also delay the process further by requesting additional hearings.

The Consumer Healthcare Products Association, representing drugmakers, argues that Americans should retain the option to choose these products. However, researchers like Randy Hatton from the University of Florida disagree. “Choosing from something that doesn’t work isn’t really a choice,” Hatton said.

Takeaway

Doctors agree that removing phenylephrine from shelves will simplify the decision-making process for consumers. “People walk into the drugstore and pick something that definitely won’t work,” said Dr. Brian Schroer of the Cleveland Clinic. “This change will guide them toward effective treatments.”