FDA proposes end to decongestant element

The Food and Drug Administration could put a stop to the use of phenylephrine, an ingredient in over-the-counter nasal decongestants, because its studies found it doesn’t work.

The FDA announced the proposed order Thursday after reviewing studies done 30 years ago along with newer studies looking at whether it worked when taken orally. An agency panel last year found it wasn’t effective in “cold, cough, allergy, bronchodilator and antiasthmatic drug products.”

Companies are still allowed to market and sell drugs containing phenylephrine. If the order is completed after a monthslong public comment period, those drugs would be removed from the market. Nasal sprays using the ingredient wouldn’t be affected.

If the ban is executed, the FDA would let drug manufacturers “either reformulate or remove drug products containing oral phenylephrine from the market,” Dr. Theresa Michele, director of the FDA’s Office of Nonprescription Drugs, told CNN.

Some over-the-counter drugs contain only phenylephrine while others contain it along with other ingredients. Medicine containing phenylephrine include varieties of Tylenol, Benadryl, DayQuil, NyQuil, Sudafed PE and Mucinex, according to Drugs.com.

The Consumer Healthcare Products Association, which represents makers of over-the-counter medicine, diet supplements and consumer medical devices, decried the agency’s assessment that phenylephrine is ineffective.

The association said it is “disappointed in FDA’s proposal to reverse its long-established view of oral PE (phenylephrine). For decades, people have relied on oral PE to relieve their nasal congestion. … PE is the only oral OTC decongestant available without purchase restrictions and is included in numerous OTC cough and cold medicines labeled with a decongestant claim. Consumers need options for self-care and freedom of choice.”

Another ingredient, pseudoephedrine, lent its name to Sudafed and was available over the counter until 2005. Regulators moved it behind pharmacy counters because in large quantities it can be used to produce methamphetamine, according to CNN.