FDA issues drug misuse guidance

By Antwaun ParrishOctober 26, 2022

 Recently, the Food and Drug Administration issued a warning about an over-the-counter drug and the harmful impacts of misuse.

Benzedrex is a nasal decongestion inhaler and 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.

“Given the very small quantity of d-methamphetamine in each manufacturer’s recommended dose, a positive d-methamphetamine result could indicate ingestion of this product in an abusive and dangerous manner,” said Tom Gilliard, ARD ASAP program manager.

“If not used in accordance with the manufacturer’s instructions, the trace quantity of d-methamphetamine impurity in the product may be sufficient to surpass the DoD cutoff for d-methamphetamine,” Gilliard said.

According to the FDA, the health risks for individuals abusing propylhexedrine includes psychosis, pulmonary disease, and sudden death.

“The FDA is requesting that all manufacturers of OTC propylhexedrine nasal decongestant inhalers consider product design changes that support its safe use,” said Gilliard. “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 Office of Drug Demand Reduction provides guidance on disciplinary action for this inhaler when there is suspected misuse.

“When disciplining a member for suspected use of any drug, it is important to consult your servicing legal office for current requirements on how to proceed,” said ODDR. “This is especially important when the evidence supporting discipline consists of scientific reports and data that may require special assistance in their interpretation. In cases involving Benzedrex®, legal consultation is highly recommended.”