FDA says abusing one OTC inhaler product can lead to serious health issues

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Misusing the nasal decongestant could cause cardiovascular issues and psychiatric events

The Food and Drug Administration (FDA) is warning that abusing or misusing the nasal decongestant propylhexedrine (Benzedrex) can produce serious cardiovascular and psychiatric events. 

The inhaler, which is sold over-the-counter, is marketed to temporarily relieve nasal congestion due to cold, hay fever, or other upper respiratory allergies. But since the beginning of 2000, 460 cases of propylhexedrine abuse or misuse have been reported to U.S. poison control centers. Another 53 cases were reported directly to the FDA, and seven other cases were identified through emergency department visits between 2016 and 2018. 

Although the nasal decongestant is safe and effective when used for short periods of time for its intended use, poison control centers say they have received reports of toxicity associated with the use of Benzedrex. 

"Benzedrex inhalers can be legally purchased, but propylhexedrine abuse occurs as people try to find legal ways to get high or increase productivity and concentration," the National Capital Poison Center stated. "There have been many reports of toxicity associated with propylhexedrine extracted from an inhaler and swallowed or injected. Swallowing the contents of one propylhexedrine inhaler has caused heart attack and lung injury in adults and children."

FDA calls for design changes

Patients who abused or misused the inhaler most commonly reported the following side effects: tachycardia, severe anxiety or agitation, hypertension, angina, tremor, hallucinations, delusions, confusion, nausea, and vomiting. Twenty-one people experienced life-threatening adverse reactions after misusing the inhaler.

The FDA said people who experienced adverse health complications primarily cited using the products “by routes other than nasal inhalation.” The agency is now urging the makers of the inhalers to change the design to prevent misuse. 

“For example, modifying the product to create a physical barrier that would make tampering with the device and abusing the propylhexedrine inside more difficult,” the agency said. “In addition, decreasing the amount of medicine the device contains could also reduce the risk of serious side effects if abused or misused.” 

The agency said it’s continuing to “evaluate this safety issue” in order to determine whether additional regulatory actions are needed. In the meantime, consumers can report adverse events linked to propylhexedrine to the FDA MedWatch program.

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