FDA warns that abuse and misuse of propylhexedrine causes serious harm

Abuse and misuse of propylhexedrine, an OTC nasal decongestant, can cause serious harm, such as heart and mental health issues, FDA warned Thursday. Some of the complications—including fast or abnormal heart rhythm, high blood pressure, and paranoia—can result in hospitalization, disability, or death. In its Drug Safety Communication, FDA noted that propylhexedrine is safe and effective when used as directed; but reports of individuals abusing and misusing the drug have increased in recent years. The agency is asking all manufacturers of OTC propylhexedrine nasal decongestant inhalers to consider product design changes that support its safe use, such as modifying the product to create a physical barrier that would make tampering with the device and abuse the drug inside more difficult. Reducing the amount of medicine in the device could also lower the risk of serious adverse effects if abused or misused, FDA said. The agency cautioned consumers to only use OTC propylhexedrine according to the directions on the Drug Facts label. Additionally, FDA said health care professionals should know that some people are abusing or misusing the drug, particularly using it by routes other than nasal inhalation. In the event of a suspected overdose, health care professionals should try to determine whether a patient used propylhexedrine alone or with other substances. As there is no specific reversal agent in cases of acute intoxication, symptomatic and supportive care should be provided.