If you watch the news at all, you know about this but, more importantly for anyone that has taken phenylephrine, the lack of efficacy should have been very noticeable, especially if you have ever taken pseudoephedrine. The FDA has just issued a statement (here), clarifying the Advisory Committee’s recommendation regarding the lack of efficacy of oral phenylephrine and how it will proceed to a final decision. The FDA noted that phenylephrine nasal spray is not affected by the Ad Com’s findings.

I can remember when pseudoephedrine was the go-to decongestant (remember those little red 30 mg pills?) until the product went behind the counter, and only in pharmacies, to prevent large purchases for diversion purposes as the drug can easily be converted to methamphetamine. Well, it is still my go-to decongestant because it works and is very effective! But to obtain the drug, you must present your driver’s license, even as an OTC product. There is a national screening program that instantly tells the pharmacist, once your license is swiped, the last time you purchased the drug. There is, as you likely know, also a limit on how much of the drug you can buy in a single transaction. God forbid that you have a really long-lasting cold or nasal problem as you may run into a problem being able to access the product in sufficient quantity to fully treat your symptoms.

This change in the law regarding the sale of pseudoephedrine precipitated the need to find another decongestant that could replace pseudoephedrine in the hundreds of single-entity and combination products that were being marketed OTC. Because phenylephrine was an ingredient originally found in the OTC monograph and the only other decongestant product generally recognized as safe and effective (GRASE), the industry moved forward and reformulated many of the OTC products that contained pseudoephedrine, and pseudoephedrine moved behind the counter with strict controls on its availability. Since that time, new research has demonstrated the apparent lack of efficacy of phenylephrine, resulting in the Ad Com’s recommendation.

The FDA notes the following in clarifying the recommendation:

  • “The committee discussed new data on the effectiveness of oral phenylephrine and concluded that the current scientific data do not support that the recommended dosage of orally administered phenylephrine is effective as a nasal decongestant. However, neither FDA nor the committee raised concerns about safety issues with use of oral phenylephrine at the recommended dose.”
  • “If FDA determined that oral phenylephrine is not effective, the agency would first issue a proposed order removing phenylephrine from this monograph.”
  • “The public would then have the opportunity to comment on the proposed order. If, after considering the comments, FDA continued to conclude phenylephrine is not effective, the agency would issue a final order removing this ingredient from the monograph, and phenylephrine would no longer be considered GRASE.”
  • “FDA would then work closely with manufacturers to reformulate products as needed to help ensure availability of safe and effective products to treat symptoms of colds or allergies.”

So, while the FDA has not made a final determination, my guess is that it’s a fait accompli. The only question in my mind is, how long it will take the Agency to reach its final decision given what could be a rather lengthy process as outlined above? We will keep you informed but, If I were a betting man, I would advise manufacturers to watch their inventories of these products until the final path is clear.