A Food and Drug Administration (FDA) advisory committee held a meeting on Sept. 11-12 to decide if the drug phenylephrine should continue to be sold as a treatment for nasal decongestion. This drug is found in many cold and allergy medicines.
The committee voted that the data demonstrate that oral versions of phenylephrine are not effective. The FDA will now decide whether or not it will continue to allow the medicine to be sold in oral formulations to treat nasal congestion.
This is important for people with nasal allergies (allergic rhinitis, or “hay fever”) because this could affect the medicines easily available as part of allergy treatment.
What Is Phenylephrine?
Phenylephrine is a medicine you can buy over the counter (OTC) for nasal congestion caused by allergic rhinitis or the common cold. It is sold by itself or in combination medicines that treat cold, flu, and allergy symptoms.
Medicines that contain phenylephrine include:
- Eye drops
- Nasal sprays
Some examples of medicines that contain oral phenylephrine include SUDAFED® PE, Mucinex® SINUS-MAX®, and Benadryl Allergy Plus Congestion.
Why Is the FDA Reviewing Oral Phenylephrine for Nasal Congestion?
The FDA is reviewing the use of oral phenylephrine because there is a concern that it is not effective as a nasal decongestant. The medicine has been around since the 1970s. Many of the older studies done on the drug were not sound or used older methods. Newer studies do not show oral phenylephrine to be effective as a nasal decongestant.
The FDA is only reviewing the oral versions (liquid and tablets) and not nasal sprays and eye drops. Versions used to treat other conditions will not be affected by this vote.
In fact, data do demonstrate that nasal sprays with phenylephrine are effective at reducing nasal congestion. But they should not be used for more than three days at a time. Continued use of nasal phenylephrine can lead to “rebound” phenomenon. This is a situation where stopping the medicine could lead to worsening symptoms, as well as the fact that more medicine is needed to achieve the same level of decongestant effect.
What Happens If the FDA Reclassifies Oral Phenylephrine?
If the FDA reclassifies oral phenylephrine, the drug will no longer be sold as a nasal decongestant. That means many popular OTC oral cold and allergy medicines will no longer be sold.
This may be concerning for people with nasal allergies. Nasal decongestants, used for a short time period, can be part of a treatment plan for allergic rhinitis and colds.
If you currently rely on an oral medicine that contains phenylephrine, talk with your doctor about other more effective treatment options. (And remember, decongestants should only be used for one to three days.)
Can a Nasal Corticosteroid Spray Help My Nasal Congestion?
A nasal corticosteroid spray is a safer option for treating your nasal congestion. They work by reducing inflammation (swelling) in your nose and block allergic reactions. (Examples include Nasacort®, FLONASE®, and RHINOCORT®.)
Nasal corticosteroids work better and have fewer side effects. Unlike nasal decongestants, they are designed to be taken for a long time. Many are available over the counter. Just note that nasal steroids do not give immediate relief and may take up to a week to 10 days before having a full effect. Using them regularly keeps nasal symptoms under control.
What Other Treatments Can I Use for Nasal Congestion?
If you have nasal congestion due to allergies, you do have other options to help manage your symptoms. A combination of treatments while reducing your exposure to your allergens can help you manage your allergic rhinitis symptoms.
The first and best option to manage allergic rhinitis is to avoid contact with allergens that trigger nasal symptoms. If reducing your exposure to your allergens isn’t enough, there are other treatment options. Many are available over the counter.
Pseudoephedrine is another OTC medicine that treats nasal congestion. But current laws make it harder to buy. It is only sold directly from pharmacies, so you have to go to a pharmacy counter to purchase it. Laws also limit how much you can buy.
If you have high blood pressure or heart disease, you may not be able to take pseudoephedrine. It may raise your blood pressure. If you have thyroid disease, glaucoma, or trouble urinating, talk with your doctor about using pseudoephedrine.
If you do not get complete relief from medicines or managing your allergen exposure, talk with an allergist about immunotherapy (allergy shots or tablets). Immunotherapy is a long-term treatment that can help prevent or reduce allergic reactions.
Allergy Medicine Guide
Nasal rinse: Using a saline (saltwater) nose rinse can help cut down mucus and rinse pollen out of your nose. Remember to use these as directed.
Nose sprays: Corticosteroid nose sprays are effective and have few side effects. They treat swelling and inflammation in your nose. (Examples include Nasacort®, FLONASE®, and RHINOCORT®.) Antihistamine nasal sprays such as Astelin and Patanase are also effective options.
Eye drops: Allergy eye drops can be very helpful in managing eye allergy symptoms. They can relieve burning sensation, itchiness, redness, increased tearing, and swelling. Common eye drops include SYSTANE® ZADITOR®, Optivar, and Pataday®. In addition, artificial tears can be helpful – but be aware of current FDA recalls on eye drops.
Antihistamines: Antihistamines come in pill, liquid, or nasal spray form. They can relieve sneezing and itching in the nose and eyes. They also reduce a runny nose and, to a lesser extent, nasal stuffiness. Look for a long-acting, non-drowsy antihistamine. (Examples include ZYRTEC®, Claritin®, Allegra®, CLARINEX®.)
Decongestants: Decongestants are available as pills, liquids, nasal sprays, or drops. They help shrink the lining of the nasal passages and relieve stuffiness. They generally are only used for a short time (usually three days or less – examples include SUDAFED®, Vicks Sinex™, Afrin®). Check with your doctor before using decongestants if you have high blood pressure, glaucoma, thyroid disease, or trouble urinating.
Leukotriene modifiers (such as montelukast): This medicine can help by blocking chemicals your body releases when you have an allergic reaction. (Examples include SINGULAIR®, Zyflo CR®, ACCOLATE®.)
Note: Montelukast (brand name SINGULAIR®) has a black box warning. This is a safety warning from the Food and Drug Administration (FDA). This means you need to be aware of a drug’s side effects or important instructions for safe use of the drug. We encourage you to speak with your health care provider before, during, and after the start of any new medicine. If your doctor recommends montelukast, talk with them about possible risks and concerns.
Cromolyn sodium: This is a nasal spray that blocks the release of chemicals that cause allergy symptoms, including histamine and leukotrienes. This medicine has few side effects, but you must take it four times a day. (Examples include NasalCrom®)
How do you manage your nasal allergies? Tell us in the comments below.
Medical Review: Sept. 2023 by Mitchell Grayson, MD