On March 25th, the U.S. Food and Drug Administration (FDA) is warning that the abuse and misuse of the over-the-counter (OTC) nasal decongestant propylhexedrine can lead to serious harm, such as heart and mental health problems. Some of these complications, which include fast or abnormal heart rhythm, high blood pressure, and paranoia, can lead to hospitalization, disability, or death.

Reports of individuals abusing and misusing propylhexedrine have increased in recent years. Propylhexedrine is safe and effective when used as directed.

The FDA is requesting that all manufacturers of OTC propylhexedrine nasal decongestant inhalers consider product design changes that support its safe use. For example, modifying the product to create a physical barrier that would make tampering with the device and abusing the propylhexedrine inside more difficult. In addition, decreasing the amount of medicine the device contains could also reduce the risk of serious side effects if abused or misused.

The most commonly used OTC decongestant inhaler with this agent is sold under the brand name Benzedrex.

The agency says it continues to evaluate this safety issue and will determine if additional actions are needed.

See the full Drug Safety Communication “FDA warns that abuse and misuse of the nasal decongestant propylhexedrine causes serious harm” for more information.