The Food and Drug Administration (FDA) has determined that abuse or misuse of propylhexedrine (Benzedrex) nasal decongestant is a growing problem that can result in serious or life-threatening adverse effects. The FDA came to this conclusion after reviewing data from its Adverse Event Reporting System database and others, as well as 49 case reports and an observational study in the medical literature.
Propylhexedrine is used for the relief of nasal congestion due to colds, allergic rhinitis, and sinusitis. It was created in the 1940s as a replacement for amphetamine in inhalers in response to abuse and deaths from amphetamines, which were extracted from these products.1 In therapeutic doses, propylhexedrine provides nasal decongestion by stimulating [alpha]-adrenergic receptors and causing localized vasoconstriction, which shrinks swelling and inflammation of the mucus membrane in the nose. In higher doses, propylhexedrine increases the release of dopamine, norepinephrine, and serotonin from presynaptic vesicles, similar to amphetamines.2 In the 1970s, case reports of propylhexedrine abuse to obtain a "legal high" with psychostimulant effects began to appear in the literature.1 Although the drug is designed to be inhaled, propylhexedrine abuse occurs most commonly via ingestion, as well as via intravenous injection and excessive inhalation. In a few cases, people were noted to have smoked propylhexedrine. The drug is abused by forcing open the plastic container and removing the propylhexedrine-soaked cotton swab. The swab can be cut up and swallowed or soaked in a liquid to extract the drug. Extraction methods can be found online.1
The adverse effects of propylhexedrine are related to its sympathomimetic effects and can present as significant tachycardia and hypertension.2 The two most serious adverse effects are cardiac and psychiatric; death is possible. Serious types of cardiac adverse effects include myocardial infarction, arrythmias, heart damage, pulmonary hypertension, chest pain, and ischemic limb injury. Common psychiatric adverse effects include severe agitation, hallucinations/delusions, paranoia, anxiety, and confusion. Additional adverse effects are cardiovascular (stroke), neurologic (seizures), and from excessive adrenergic stimulation (mydriasis, nausea and vomiting, tremor, diaphoresis, hyperthermia, dehydration, urinary frequency).1 Bowel obstruction is also possible if the cotton swab is swallowed.
Patients who present with excessive sympathomimetic symptoms should be assessed for propylhexedrine abuse. There is no specific antidote for acute intoxication from propylhexedrine and management in an ED is symptomatic and supportive. Nurses and other health care providers should educate patients on the proper use of over-the-counter medications, including propylhexedrine. Patients should know not to exceed the daily recommended dose of two inhalations per nostril, administered not more often than every two hours and not for longer than three days.
To read the full FDASafety Communication regarding propylhexedrine, see http://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-abuse-and-misuse. To assist the FDA in tracking safety concerns with propylhexedrine or other medications, report adverse effects to the FDA MedWatch program: http://www.accessdata.fda.gov/scripts/medwatch.
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