United States Food & Drug administration (USFDA) released a drug safety communication to bring more awareness on potential drug misuse and abuse of propylhexedrine associated with serious complications like abnormal heart rhythm, high blood pressure, and paranoia. It is marketed under the brand name Benzedrex.

Propylhexedrine is a nasal decongestant available in the retail pharmacy stores as over the counter (OTC) medicine. It is used in getting temporary relief from nasal congestion due to colds, hay fever, or other upper respiratory allergies. This medicine works by reducing swelling and inflammation of the mucous membrane lining of the nose.

Case reports from Poison control centers:

  • USFDA identified 460 case reports for propylhexedrine pertaining to the safety concerns of drug misuse, abuse. These cases were received during the period 01-Jan-2000 to 31-Dec-2019. Age group included 12 to 68 years and most cases reported for males.
  • Most common route of administration is Ingestion followed by Inhalation & Injection.
  • The most frequent clinical effects were tachycardia, agitation, hypertension, mydriasis, nausea, chest pain, tremor, hallucinations/delusions, diaphoresis, confusion, and vomiting. 21 cases reported life-threatening adverse events and 13 cases were resulted in admission to intensive care units.

Case reports from FAERS & NEISS-CADES:

Evidence from medical literature:

  • An observational study and 49 case reports demonstrated propylhexedrine abuse and 18 fatal case reports.
  • The most common adverse events experienced in older literature reports included ischemic limb injury, cranial nerve dysfunction, psychosis, cardiomyopathy, adrenergic overstimulation, and anxiety or agitation

Important information for Consumers:

Use the product as per label instructions or as per the recommendations from a physician or pharmacist.

Do not exceed the recommended dosage.

As per USFDA, the recommended dosage of propylhexedrine for adults and children older than 6 years is two inhalations in each nostril not more than every 2 hours.  For children younger than 6, consult a health care professional before using. Do not use propylhexedrine for more than 3 days. Prolonged use may cause nasal congestion to recur or worsen. Use this medicine only as directed.

The common adverse effects of propylhexedrine may include temporary discomfort such as burning, stinging, sneezing, or increasing nasal discharge.

Seek medical attention if the below symptoms are observed:

  • Severe anxiety or agitation, confusion, hallucinations, or paranoia
  • Rapid heartbeat or abnormal heart rhythm
  • Chest pain or tightness

Important information for Health care professionals:

  • Educate patients or patient care providers or consumers on the potential adverse events of this medicine.
  • Assess individual benefit-risk analysis based on the patient’s concomitant medication use, concurrent illness and the patient’s potential for misuse/abuse of the medicine and consider not recommending this medicine if the anticipated benefits does not outweighs the potential risks of this medicine.
  • If benefit-risk profile is found favorable for that particular patient, then bring awareness on the safe usage of this medicine by informing about appropriate route of administration, frequency, expected adverse effects etc.,

Voluntary ADR reporting

Every medicinal product has both benefits and risks. Medicines are authorized to market based on the favorable benefit-risk profile anticipated at the time of regulatory approval/entry into market. However, the safety profile of medicine would continuously updates owing to safety data from the post marketing experience from public. If the rate of reporting of suspected adverse drug reactions (ADR) from public is line with the actual occurrence of ADRs, the time lapse for taking regulatory action can be reduced and thereby promotes patient safety.

All health care professionals and consumers of pharmaceutical medicinal products are encouraged to be aware of this fact and observe/monitor for any possible adverse events, reactions, medication errors, or quality complaints of medicinal products and report the same to your respective national health authority.

This would accumulate safety evidence for medicinal products which in turn help health authorities to take regulatory actions at the earliest possibility for a better patient safety and overall public health.

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