FDA Warns of Rising Misuse of Decongestant Inhalers

The active ingredient propylhexedrine produces a high similar to meth when abused

By Jason Langendorf

April 14, 2021

The misuse of over-the-counter (OTC) decongestant inhalers that contain the active ingredient propylhexedrine can lead to serious harm, the U.S. Food & Drug Administration (FDA) warns.

Propylhexedrine is safe when taken as directed, but the FDA recently issued a statement about heart and mental health risks amid reports of an increase in non-prescribed use of nasal decongestant inhalers containing the drug. Propylhexedrine is a stimulant that, when abused, produces that same type of high as methamphetamine, though for a shorter period of time. Among the potential physical complications cited by the FDA from misuse are a fast or abnormal heart rhythm, high blood pressure and paranoia. Improper use can lead to hospitalization, disability or even death.

The [FDA] is requesting that the manufacturers of over-the-counter (OTC) decongestant inhalers consider design changes that ‘support safe usage.’ ”

Over a 20-year period ending Dec. 31, 2019, U.S. poison control centers documented 460 cases of propylhexedrine abuse or misuse. And, according to the FDA, “There are likely additional cases that we have not identified.” Propylhexedrine, which reduces swelling and inflammation of the nasal lining, replaced amphetamine sulfate as the active ingredient in nasal decongestants in 1949 in response to similar misuse of that drug. The FDA says there is no specific reversal agent in cases of acute propylhexedrine intoxication.

Combating Propylhexedrine Misuse

In many of the recent cases of abuse and misuse, propylhexedrine is removed from the inhaler for oral ingestion or intravenous injection. The agency is requesting that manufacturers of OTC decongestant inhalers consider design changes that “support safe usage.”

Those alterations include “modifying the product to create a physical barrier that would make tampering with the device and abusing the propylhexedrine inside more difficult.” In addition, the FDA notes in its warning, “decreasing the amount of medicine the device contains could reduce the risk of serious side effects if abused or misused.”

The agency directs the public to use propylhexedrine only according to the directions listed on the information label and urges people who experience the following symptoms from using the drug to seek immediate medical attention by calling 911 or poison control at 1-800-222-1222: