Abuse of OTC Decongestant Potentially Deadly, FDA Warns

Megan Brooks

March 25, 2021

Abuse or misuse of the over-the-counter (OTC) nasal decongestant propylhexedrine can cause serious harm that can lead to hospitalization, disability, or death, the US Food and Drug Administration (FDA) warns in a safety communication.

"Major issues" that may have to be managed in the context of acute intoxication with propylhexedrine include severe agitation, tachycardia, hypertension, myocardial infarction, hyperthermia, stroke, bowel obstruction, pulmonary hypertension, and seizures, the FDA said.

There is no specific agent for reversing the effects of acute propylhexedrine intoxication, so management is symptomatic and supportive, the FDA notes.

Reports of individuals abusing and misusing propylhexedrine have increased in recent years.

Over past two decades, US poison control centers documented 460 cases of propylhexedrine abuse (415 cases) or misuse (45 cases). On a yearly basis, cases increased from 11 in 2011 to 74 in 2019; abuse cases constituted most of this increase, the FDA said.

Most of the cases involved abuse or misuse of propylhexedrine alone without other substances.

In these cases, the most commonly reported side effects were rapid heart rate, agitation, high blood pressure, chest pain, tremor, hallucinations, delusions, confusion, nausea, and vomiting.

Of the 460 cases, 21 involved life-threatening adverse effects; 13 lead to admission to intensive care.

From 1969 through 2020, 53 cases of propylhexedrine abuse and misuse were voluntarily reported to the FDA via the Adverse Event Reporting System.

During the 3-year period 2016–2018, an additional seven cases of serious adverse events related to propylhexedrine abuse were reported through the National Electronic Injury Surveillance System-Cooperative Adverse Event Surveillance Project.

Of these 60 cases, 23 patients suffered life-threatening adverse events or hospitalization, and nine died. Most of the deaths resulted from propylhexedrine abuse in combination with use of other substances.

"There are likely additional cases that we have not identified," the FDA said.

The agency is requesting that all manufacturers of OTC propylhexedrine nasal decongestant inhalers consider product design changes to ensure safe use.

"For example, modifying the product to create a physical barrier that would make tampering with the device and abusing the propylhexedrine inside more difficult. In addition, decreasing the amount of medicine the device contains could also reduce the risk of serious side effects if abused or misused," the FDA said.

The agency is continuing to evaluate this safety issue to determine whether additional action is needed. Healthcare professionals can report adverse reactions related propylhexedrine to the FDA MedWatch program.

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