Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. This is Lesley Navin, Advanced Practice Nurse.
On March 25, 2021, FDA warned that the abuse and misuse of the over the counter (or OTC) nasal decongestant propylhexedrine (brand name Benzedrex), 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.
We 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. We continue to evaluate this safety issue and will determine if additional FDA actions are needed.
Health care professionals should be aware that some individuals are abusing or misusing propylhexedrine, particularly using it by routes other than nasal inhalation. In the event of a suspected overdose, attempt to determine whether a patient used propylhexedrine alone or with other substances. There is no specific reversal agent in cases of acute intoxication so symptomatic and supportive care should be provided.
We reviewed cases from U.S. poison control center calls, case reports submitted to FDA, the medical literature, and emergency department visits. Most of the cases involved abuse or misuse of propylhexedrine alone, without other substances, and some harms occurred several hours after abuse. Most of the deaths resulted from propylhexedrine abuse in combination with other substances.
We also reviewed 49 case reports and an observational study published in the medical literature. These publications showed similar findings compared to the cases identified from poison control calls, emergency department visits and the cases reported to FDA.
To help FDA track safety issues with drugs, we urge health care professionals to report side effects involving propylhexedrine to FDA’s MedWatch program at www.fda.gov/medwatch.
A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at email@example.com.
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