Source: FDA | April 19, 2021
FDA warns that abuse and misuse of the nasal decongestant propylhexedrine causes serious harm
This includes heart and mental health problems or death
FDA Drug Safety Communication
What safety concern is FDA announcing?
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.
What is FDA doing?
They are 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 FDA continues to evaluate this safety issue and will determine if additional FDA actions are needed.
What is propylhexedrine and how can it help me?
Propylhexedrine is a nasal decongestant that is available OTC in an inhaler. It is used short-term to temporarily relieve nasal congestion due to colds, hay fever, or other upper respiratory allergies. It works by reducing swelling and inflammation of the mucous membrane lining of the nose. The recommended dose for adults and children older than 6 years is two inhalations in each nostril not more often than every 2 hours. Do not use it for more than 3 days at a time. Prolonged use may cause nasal congestion to recur or worsen. Currently, propylhexedrine is only marketed under the brand name Benzedrex.
What should consumers do?
Consumers should only use propylhexedrine according to the directions on the Drug Facts label.
Do not use it in ways other than by inhalation because doing so can cause serious harm, such as heart and mental health problems. Some of these problems can lead to death.
Seek medical attention immediately by calling 911 or poison control at 1-800-222-1222 for anyone using propylhexedrine who experiences the following:
Severe anxiety or agitation, confusion, hallucinations, or paranoia
Rapid heartbeat or abnormal heart rhythm
Chest pain or tightness Ask a pharmacist or your health care professional if you have any questions about propylhexedrine, how to use it, or whether a medicine you are taking may interact with it.
Always tell your health care professionals about all medicines you are taking, including OT medications.