Just as cold and flu season arrives, the Food and Drug Administration has proposed pulling many decongestants from store shelves.
The reason? An administration review found oral phenylephrine — a common ingredient in over-the-counter cold medications — doesn’t work. For some products, it is the only ingredient, the FDA said in a news release issued Thursday, while other products contain oral phenylephrine along with acetaminophen, dextromethorphan or another active ingredient.
For the millions of consumers who suffer from colds and allergies and many of whom have used products with phenylephrine for years, the panel’s decision may be surprising and leave them scrambling for alternatives.
Phenylephrine is still considered to be effective in nasal sprays. The FDA’s action is only related to phenylephrine taken by mouth and not the nasal spray form.
Among the products containing oral phenylephrine as an active ingredient are Sudafed PE, Vicks Nyquil, Sinex Nighttime Sinus Relief and Benadryl Allergy Plus Congestion and generic medications.
“It is the FDA’s role to ensure that drugs are safe and effective,” Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in the release. “Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”
To determine the ingredient’s effectiveness, the agency reviewed “all available data,” including the original, 30-year-old determination that oral phenylephrine works and research since then.
The FDA also held a meeting last year to study the “Generally Recognized as Safe and Effective” status of oral phenylephrine as a nasal decongestant, the release stated. The committee “unanimously concluded that the current scientific data do not support that the recommended dosage in the OTC cold, cough, allergy, bronchodilator and antiasthmatic drug products monograph for orally administered phenylephrine’s effectiveness as a nasal decongestant.”
The administration pointed out these products are not a safety concern. They just don’t work. Also, this is a proposed order, so consumers can still buy the medication for now. Only a final order will affect what products can be marketed.
“Consumers should know that a range of safe and effective drugs and other treatments is available to temporarily relieve congestion symptoms due to allergies or a common cold,” Theresa Michele, M.D., director of the Office of Nonprescription Drug Products in CDER, said in the release. “Consumers can also talk to their doctor or pharmacist about ways to treat these symptoms.”
But what about people who already have pills or liquids with the ingredient in their medicine cabinet? Doctors say people can safely take them. Other ingredients in a combination product may still provide relief, such as products that also treat fever, headache or other cold symptoms.
Danny Branstetter, medical director of infection prevention for Wellstar Health System, said he supported the panel’s recommendation to ban phenylephrine because the research has shown it is not effective in liquid or pill form.
But he noted other effective nasal congestions known to be effective are still widely available. Pseudoephedrine, the decongestant found in Sudafed, is highly effective in helping people with stuffy noses breathe more easily, he said.
But Sudafed with pseudoephedrine is sold only behind the counter and in limited amounts to consumers who must provide photo ID. That’s because pseudoephedrine can be used to manufacture the street drug methamphetamine.
Medicated nasal sprays, including those containing phenylephrine, can also relieve nasal congestion. These products are sold under the brand name Afrin and others.
Doctors say oral antihistamines like Zyrtec, Allegra and Claritin can also help with congestion but they work a little differently than decongestants, which reduce the swelling of blood vessels in the nasal passages. Antihistamines also reduce the swelling and irritation but by blocking the chemicals in the body responsible for those reactions.
Dr. Christopher Chu with Atlanta Allergy & Asthma noted many mainstays of treatment for allergies including steroid and antihistamine nasal sprays continue to also be available.
Chu and Branstetter said medications are not the only way to relieve congestion. Some nondrug approaches such as humidifiers, a steam shower, and saline nasal spray can soothe nasal passages and provide relief from congestion. Branstetter also recommended drinking lots of fluids to help to decrease congestion.
Vicks VapoRub is not a decongestant but the menthol in the ointment might make you feel less congested.
And for those suffering from lingering congestion from allergies, they recommend they talk to a doctor to discuss a prescription to help with those symptoms.
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