Abuse of OTC Decongestant Potentially Deadly, FDA Warns
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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 FDA warns in a safety communication. Major issues 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. 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.

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