- A main ingredient in many over-the-counter decongestants called phenylephrine does not work, an advisory panel for the FDA announced.
- The panel agreed further research to test higher doses of the drug would not be beneficial.
- To treat congestion, some over-the-counter medications and steroid nasal spray can be helpful. Also, staying hydrated and massaging the sinus can help relieve pressure.
A key component in many over-the-counter decongestants called phenylephrine is not effective, according to a Food and Drug Administration advisory panel.
Phenylephrine is an ingredient found in Sudafed PE, Vicks Nyquil Sinex Nighttime Sinus Relief and Benadryl Allergy Plus Congestion.
The panel stated that research doesn’t prove that the nasal decongestant works when taken orally at suggested doses. They agreed that conducting additional studies to test higher doses of the decongestant would not be useful.
“The FDA report on phenylephrine can be a little confusing,” said Dr. Anjali Bharati, ER physician at Lenox Health Greenwich Village. “To be clear, they are saying that oral phenylephrine is not better than placebo in resolving nasal congestion. They are referring to oral phenylephrine preparations, such as those found in multi-symptom, cough and cold medication.”
Often phenylephrine is a part of a cold/sinus medication and is not the only agent. The FDA panel is saying that phenylephrine, when taken in an oral pill form, is ineffective for improving nasal congestion, Bharati added.
“I think if a medication is available over the counter and is recommended for a specific medical condition, it needs to be effective for that medical condition,” Bharati stated. “If it is found that the medication is not effective, and the side effects may do more harm than good, the public needs to be aware, and the medication should be removed from that indication.”
The advisors also explained that examining phenylephrine at higher doses was not recommended since it can elevate blood pressure and pose a serious health risk.
“Increasing the dosage increases the risk of side effects,” said Dr. Wynne Armand, a physician at Massachusetts General Hospital. “There have been studies that even at a higher dose it still wasn’t effective or better than a placebo.”
In the doses available over the counter, phenylephrine is known to elevate blood pressure, Bharati explained. Since it already does this at a low dose, it may have a more profound effect on blood pressure at higher doses.
“Finding that this medication is ineffective at treating nasal congestion, is an important finding because it can elevate blood pressure in patients without providing them the intended improvement in their nasal congestion,” Bharati stated. “So far, the over-the-counter doses have not raised any safety issues with regards to blood pressure; however, it is known that patients with existing high blood pressure and glaucoma should avoid these medications or use them with caution.”
Phenylephrine is one ingredient of multi-symptom, cough, and cold/sinus medications. Other medications in the multisymptom formulations are effective for reducing some of the other symptoms.
For example, if you have an over-the-counter cold and sinus medication that contains phenylephrine, it also contains other agents like guaifenesin and dextromethorphan that are effective at reducing cough, Bharati explained.
The other preparation of phenylephrine, such as the nasal spray, is effective for reducing nasal congestion and will still be available to purchase without a prescription, Bharati noted.
However, nasal spray is usually more effective for seasonal allergy symptoms than for symptoms related to cold and seasonal flu.
“The only other oral decogestant that we commonly use is pseudoephedrine, which has not been called into question,” said Armand.
A stuffy nose and sinus congestion, associated with viral infections, such as the common cold, are best managed with supportive care.
Additionally, some at-home remedies can be helpful in relieving symptoms.
“Drinking plenty of water and hydrating can thin the mucus and secretions that cause some thickened nasal congestion, or sinus congestion. A gentle sinus massage can also help sinus drainage,” said Bharati.
Over-the-counter allergy medications like Zyrtec and Claritin are also effective at reducing runny nose and sinus congestion. Nasal sprays have been found to be effective for reducing symptoms of nasal congestion.
Pseudoephedrine is still a very effective agent for reducing the symptoms of stuffy nose and sinus congestion, Bharati added.
Additionally, Armand recommends steroid nasal spray (glucocorticoid).
“There are a lot of cold symptoms that can be treated with combination medications,” said Armand. “For example, there are cough suppressants that break up the mucus. And there are specific medications for cold symptoms such as fever and body aches.”
An advisory panel for the FDA announced a key ingredient in many over-the-counter decongestants called phenylephrine is ineffective.
Additional ways to treat congestion include some over-the-counter symptoms and using a steroid nasal spray can manage symptoms. Drinking plenty of water and massaging the sinus can also be beneficial.