In March 2021, the US Food and Drug Administration (FDA) issued a Drug Safety Communication about the over-the-counter (OTC) nasal decongestant Benzedrex (propylhexedrine) which can result in serious harm if abused or misused. Benzedrex is an OTC inhaler that is used to temporarily relieve nasal congestion due to colds or allergies, such as hay fever. The product works well by reducing swelling and inflammation in the nose. But if too much is used, side effects such as a rapid heart rate, agitation, high blood pressure, tremors, hallucinations, delusions, confusion, nausea, and/or vomiting may occur.
The main ingredient in Benzedrex is propylhexedrine, which is a stimulant. In recent years, US poison centers have seen an increase in cases of abuse and misuse. In 2011 there were 11 documented cases and in 2019 there were 74 documented cases. FDA states that most of these cases were related to abuse. Some believe the drug helps improve concentration and productivity. But abusers of the drug say that, although they have more energy, their productivity does not increase. Abusers generally do not inhale the medicine nasally as intended. They may swallow or inject the drug into their veins, which is even more dangerous. Unlike some other abused medicines, such as narcotics (opioids), there is not a specific drug that can reverse the effects of an overdose of Benzedrex.
FDA is asking all manufacturers of OTC propylhexedrine nasal decongestant inhalers to consider redesigning their products to improve safe use. Decreasing the amount of medicine within the container and creating a tamper-evident device are just a few recommendations.
Here’s what you can do: If you purchase and use Benzedrex, read the Drug Facts label on the package and follow the directions for use exactly as stated. Seek medical attention if you or someone you are with has any of the following symptoms after using Benzedrex: rapid or abnormal heart rate, chest pain, or chest tightness. Check with your pharmacist or healthcare provider before using this medicine. Specifically ask if it will interact with any other medicines you are currently taking. Keep the nasal decongestant up and away and out of reach of children and locked away from teens and adults who might abuse the medicine.
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Published May 1, 2021
