FDA Panel deems OTC decongestant useless.

FDA Panel deems OTC decongestant useless.

Over-the-Counter Cold Remedies: A Sneezing Mirage?


For many years, people suffering from colds and congested noses have turned to over-the-counter remedies to seek relief. However, a key advisory panel for the U.S. Food and Drug Administration (FDA) recently made a unanimous decision: nonprescription oral medications containing phenylephrine, such as Sudafed PE, Vicks Sinex, and Benadryl Allergy Plus Congestion, provide no relief for congestion. This decision could potentially lead to the removal of these products from store shelves, leaving cold sufferers with limited options.

The inclusion of phenylephrine in cold remedies dates back to the 1970s, and it can be found in liquid, pill, and nasal spray forms. The prominence of medications containing phenylephrine increased when pseudoephedrine, a highly effective decongestant, became more difficult to purchase due to legislation aimed at combating the meth epidemic. In 2022, over 242 million bottles or packages of phenylephrine-containing cold remedies were sold in comparison to about 51 million containing pseudoephedrine, according to FDA briefing documents.

However, recent clinical trials, lab studies, and evidence reviews have raised doubts about the effectiveness of phenylephrine. The FDA reviewed the studies that originally approved phenylephrine and found significant methodological and statistical issues. One of the main problems seems to be that the body does not absorb phenylephrine well enough to make it useful. Higher doses might be effective, but they would also significantly raise blood pressure. As a result, the FDA concluded that phenylephrine, even at higher doses, may not be a viable nasal decongestant.

The potential removal of phenylephrine-containing cold medications from the market has generated mixed reactions. The Consumer Healthcare Products Association (CHPA) argues against the FDA’s position, citing data from multiple clinical trials demonstrating effectiveness and decades of positive in-market experience. They emphasize the potential impact on consumers and the already-strained U.S. healthcare system, urging the FDA panel to consider the real-world experience and needs of consumers.

On the other hand, some doctors have already been moving away from recommending medications containing phenylephrine. In their practices, they have found that other alternatives like pseudoephedrine, oxymetazoline nasal spray, or antihistamines are more effective. Pseudoephedrine, although subject to purchasing restrictions in most states, is still available from pharmacists with a valid driver’s license. While these restrictions may pose a barrier, they help prevent the illicit use of pseudoephedrine in the production of methamphetamine.

In conclusion, the effectiveness of phenylephrine as a nasal decongestant is being questioned, and the FDA panel’s recent decision raises concerns about the future availability of over-the-counter cold remedies containing this ingredient. While the decision regarding the removal of products from store shelves has not been finalized, it is clear that alternatives like pseudoephedrine, oxymetazoline nasal spray, and antihistamines are viable options for those seeking relief from congestion. Cold sufferers need reassurance that they can find medications that effectively treat their symptoms and help them on the journey to recovery.