AUDIENCE: Consumer, Patient, Health Professional, Pharmacy
ISSUE: The 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.
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. FDA continues to evaluate this safety issue and will determine if additional FDA actions are needed.
BACKGROUND: 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.
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 OTC medicines.
Health Care Professionals should be aware that some individuals are abusing or misusing propylhexedrine, particularly using it by routes other than nasal inhalation, which can result in serious cardiac and psychiatric adverse events or death. 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.
Health care professionals, consumers and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
[03/25/2021 - Drug Safety Communication - FDA]