In a podcast, FDA warns that abuse and misuse of the OTC nasal decongestant propylhexedrine can lead to serious harm (here). The warning first came from FDA on March 25, 2021 in the form of a drug safety communication (here).
The product marketed as Benzedrex is safe and effective when used in accordance with its labeled directions, but abuse can lead to high blood pressure and heart arrhythmias, can cause psychosis and, in some instances, can lead to death. “Benzedrex intranasal inhalers are meant to temporarily treat nasal congestion that can occur as a result of allergies or colds. Amphetamine sulfate was once the active ingredient used in Benzedrex inhalers; however, amphetamines are commonly abused and high doses can be dangerous. In 1949, amphetamine in the inhalers was replaced with propylhexedrine (see article here from the Laguna Treatment Hospital. According to one study, individuals who abuse the drug generally do not do so by using the nasal inhaler properly. Rather, they ingest the medication orally or inject it into their veins.” (here).
FDA is asking manufacturers of the product to evaluate the product packaging design to make it more difficult to manipulate the packaging and/or to include a smaller quantity of the active ingredient, propylhexedrine, to lessen the potential for abuse. The Agency indicates it will be continuing to monitor the safety issue and will determine if additional action is needed.
