Q&A: As FDA panel deems decongestants ineffective, experts discuss impact on allergy care
Click Here to Manage Email Alerts
Key takeaways:
- An FDA advisory panel deemed oral phenylephrine no more effective than placebo in treating decongestion.
- Patients should speak with their physician before seeking alternatives.
An FDA advisory panel has deemed oral phenylephrine, an ingredient in many cold and allergy medications sold over the counter to treat decongestion, no more effective than placebo.
The FDA is not required to follow the recommendations of its advisory panels, but it often does so. In this case, that may mean calling for the removal of oral phenylephrine from many OTC cold and allergy medicines.
We spoke with Douglas H. Jones, MD, FAAAAI, FACAAI, cofounder of Global Food Initiative and a Healio Allergy/Asthma Peer Perspective Board Member; Marilyn Li, MD, associate professor of pediatrics and clinician educator at the University of Southern California; and Zachary E. Rubin, MD, pediatric allergist and spokesperson for the American College of Allergy, Asthma & Immunology, to find out what impact this decision will have on patients with allergy.
Healio: Were you surprised by the FDA’s decision?
Jones: I was not surprised by the findings at all. Allergists have known this for many years. I was pleasantly surprised the FDA actually reviewed it, took another look and had the courage to make the decision they did. I would encourage more of this, including not only whether a medication is effective but also the safety profiles and data behind alternatives.
Li: No, the decision was not too surprising, given that both popular opinion and the data point to the fact that oral phenylephrine does not relieve symptoms.
Rubin: I was not surprised by the FDA’s Nonprescription Drug Advisory Committee’s decision. Multiple randomized, placebo-controlled clinical trials did not show that oral phenylephrine was superior to placebo in treating nasal congestion. This medication has been under scrutiny for quite some time.
The American Academy of Allergy, Asthma & Immunology and the ACAAI have supported the Nov. 4, 2015, Citizen’s Petition submitted to the FDA by Leslie Hendeles, PharmD, and Randy C. Hatton, PharmD. I have not recommended oral phenylephrine for my patients.
Healio: Do patients with allergies often turn to these drugs for relief?
Jones: Yes, patients turn to these drugs and others for relief. They are looking for that quick relief while congested and for an option so they do not have to go to the doctor. That is understandable. I think so often, we as a society are led by marketing more than actual science or evidence. Tony Robbins, a global entrepreneur, often says, “Where focus goes, energy flows.” I think that quote could be rephrased, “Where the dollar goes, information flows.”
Li: My thoughts are that these medications are used commonly because they are over the counter. Because oral pseudoephedrine is “behind the counter,” and sold in small quantities, oral phenylephrine is likely used more often.
Rubin: Many patients with allergies, colds and sinus issues turn to oral phenylephrine for relief, but many do not even know that they are taking this medication. Oral phenylephrine is found in numerous OTC medications, such as Sudafed PE (Johnson & Johnson), DayQuil (Procter & Gamble), Tylenol Cold + Flu Severe for Day and Night Time (Johnson & Johnson), Alka-Seltzer Plus Cold (Bayer), Mucinex Maximum Strength Fast-Max Day Cold & Flu and Night Cold & Flu (Reckitt), and Vicks Sinex Nighttime (Procter & Gamble). In 2022, more than 240 million bottles and packages containing phenylephrine were sold in the United States.
Healio: Would you agree that these drugs have no impact on allergic symptoms?
Jones: I agree they have had very little actual impact.
Li: The medications containing oral phenylephrine usually have other medications including antihistamines, so some people might feel that their symptoms are better. The FDA analysis is specific for oral phenylephrine alone not improving nasal stuffiness, and it correlates with my personal experience with phenylephrine. The FDA evaluated five studies over 2 decades and found no difference from placebo.
Rubin: I agree that this drug does not have an impact on nasal congestion. Patients who do report benefit likely are experiencing a placebo effect.
Healio: Do these drugs present any dangers for patients with allergies?
Jones: There are some side effects occurring at very large doses of the medications.
Li: Common side effects are insomnia and headaches, and they can worsen issues with high blood pressure. There are no particular additional issues in patients with allergies, other than the possibility of people with allergies not using their prescribed or recommended allergy medication because they are using OTC phenylephrine.
Rubin: Phenylephrine may cause anxiety, nervousness, headache, trouble sleeping, heart palpitations, increased blood pressure and even allergic reactions.
Healio: What would you recommend for patients looking for alternatives?
Jones: I recommend that patients talk with their doctor or an allergist/ENT who specializes in nasal congestion and is most familiar with the variety of products available. Often, it is not a cookie-cutter answer. Depending on the individual’s particular history, some alternatives may be more appropriate for some people.
Li: Oral pseudoephedrine is available and more effective. Topical phenylephrine and oxymetazoline hydrochloride (nasal spray) are still available and effective for very short-term use.
Rubin: Fortunately, there are other decongestants that are available. As an example, there is a nasal decongestant spray called oxymetazoline hydrochloride (eg, Afrin, Bayer) that can be used. This is also an oral decongestant called pseudoephedrine (eg, Sudafed, Johnson & Johnson) that is sold behind the counter. Keep in mind that decongestant medications should only be used on a short-term basis and may not be safe for everyone to use. For example, you should talk with your doctor if you have a history of heart disease, high blood pressure or diabetes or are pregnant before starting these medications.
Healio: In the long term, what solutions would you recommend?
Jones: I would advise patients to consult with their doctor to devise a plan most suited for them and their particular health circumstances. I would be wary of products that make vague claims about being an “immune booster” or “supporting the immune system.” These phrases are red flags to me, as they really do not mean anything. What are they boosting? What are they supporting? Does the boosting and supporting make a clinical difference? I have yet to see a product with credible and reproducible data showing that they make a significant difference. If it is out there, I have not seen it.
Li: As an allergist I recommend an evaluation by a specialist for allergies to work on a personalized allergy treatment plan for each person suffering from allergies.
Rubin: If someone is struggling with nasal congestion and finds that OTC medications are not helping, then talking with their doctor about further treatment options would be helpful. They may need to see a specialist such as an allergist to address these issues.
For more information:
Douglas H. Jones, MD, FAAAAI, FACAAI, can be reached at jonesallergy@gmail.com.
Marilyn Li, MD, can be reached at marilyn@usc.edu.
Zachary E. Rubin, MD, can be reached at zrubin@gmail.com.