The Food and Drug Administration (FDA) has issued an alert regarding the risk of serious cardiovascular and psychiatric complications associated with the abuse and misuse of the nasal decongestant propylhexedrine.
Sold over-the-counter as an inhaler, propylhexedrine (Benzedrex), is a sympathomimetic indicated to temporarily relieve nasal congestion due to cold, hay fever, or other upper respiratory allergies. The drug binds to alpha-adrenergic receptors in the mucous membrane lining of the nose, which results in vasoconstriction and a reduction in swelling and inflammation.
Since January 1, 2000, there have been 460 documented cases of propylhexedrine abuse or misuse reported to US poison control centers. The most commonly reported side effects included tachycardia, agitation, hypertension, angina, tremor, hallucinations, delusions, confusion, nausea and vomiting. Life-threatening adverse effects were reported in 21 of these cases, with 13 resulting in admission to the intensive care unit.
Additional cases of abuse and misuse were also reported to the FDA directly (53 cases) and identified through emergency department visits between January 1, 2016 and December 31, 2018 (7 cases). Moreover, serious outcomes related to inappropriate propylhexedrine use were described in 49 case reports and an observational study.
Health care professionals are being advised that serious adverse events (ie, severe agitation, tachycardia, hypertension, myocardial infarction, hyperthermia, stroke, bowel obstruction, pulmonary hypertension, seizures) can occur if propylhexedrine is abused or misused, including through ingestion or injection. For patients in whom acute propylhexedrine intoxication has been identified, management should be symptomatic and supportive as there is no specific reversal agent. Lung damage, arrhythmias, and cardiac damage may also be present with long-term use.
Adverse events involving propylhexedrine should be reported to the FDA MedWatch program.
FDA warns that abuse and misuse of the nasal decongestant propylhexedrine causes serious harm. [press release]. Silver Spring, MD: US Food and Drug Administration; March 25, 2021.