FDA Issues Safety Alert for Over-the-Counter Decongestant

March 25, 2021 – The U.S. FDA has issued a warning that abuse and misuse of nasal decongestant propylhexedrine, an over-the-counter (OTC) product sold under the brand name Benzedrex® (B.F. Ascher & Co.), can cause serious and potentially fatal harm. When used as directed, however, the drug is considered safe and effective to treat nasal congestion caused by colds, hay fever, or other allergies.

Nasal propylhexedrine is intended to be used as an inhaler at a dose of no more than two inhalations in each nostril every two hours. An adult should supervise use of the product by children 6-12 years of age, and it should not be used by children less than six years old without first consulting a doctor. The product should be used for no more than three days.

Typically, individuals who abuse nasal propylhexedrine do so by taking it orally or injecting it intravenously. This may be done by extracting the propylhexedrine from the inhaler or consuming pieces of the inhaler, which consists of a cotton rod soaked with the medication (and potentially other ingredients such as lavender oil and menthol) inside of a plastic casing. When used as intended, the inhaler produces vapors from the cotton rod that are breathed in by the individual per package instructions.

Misuse and abuse of nasal propylhexedrine can lead to a fast or abnormal heart rhythm, high blood pressure, and paranoia. It also puts individuals at risk of hospitalization, disability, or death. The FDA has asked manufacturers of OTC propylhexedrine nasal decongestant inhalers to consider product design changes that support safe use, such as creating a physical barrier to make it harder to tamper with the inhaler and abuse the propylhexedrine inside. The FDA has also suggested decreasing the amount of medicine each device contains to reduce the risk of serious side effects if abused or misused.

A full copy of the safety communication is available on the FDA’s website.