FDA Warns of Problems Tied to Misuse of Nasal Decongestant

By Kelly Young

Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS

The FDA is warning clinicians of an increase in abuse and misuse of the nasal decongestant propylhexedrine (marketed as Benzedrex), which can result in cardiac and psychiatric events and death.

The agency is asking manufacturers of the over-the-counter product to make design changes to make it more difficult to misuse the drug, such as changing the delivery mechanism or including less product in the package. People are misusing or abusing the drug by ingesting, injecting, or inhaling it.

In the event of a suspected overdose, symptomatic and supportive care are recommended, as there is no specific reversal agent for propylhexedrine. Clinicians should also determine whether the drug was taken alone or with other substances.

The number of cases of abuse or misuse reported to poison control centers increased from 11 in 2011 to 74 in 2019. The most frequent side effects were tachycardia, agitation, hypertension, chest pain, tremor, hallucinations, delusions, confusion, nausea, and vomiting. Some 5% of cases reported to poison control were life-threatening. The FDA has received reports of nine deaths.