Overview

Propofol is indicated for the induction and maintenance of general anesthesia or sedation in children and adults during surgical or other diagnostic procedures.¹ Currently, there are 10 registered products containing propofol in Malaysia.

Priapism refers to a pathologic, prolonged, painful erection of the penis without sexual stimulation.^2,3 In most cases, it requires prompt evaluation and emergency management. There are two (2) classifications of priapism:

1. Low-flow (ischemic) priapism
   • caused by a reduced venous drainage from the corpora cavernosa, which is commonly seen in drug-induced priapism.
   • considered a medical emergency as it may lead to potentially irreversible damage and impotency if not treated within 24 hours.
2. High-flow priapism
   • precipitated by an increase in arterial inflow, which is commonly happens in post-trauma.
   • not considered a medical emergency as it usually resolves spontaneously without any complications.

Background of Safety Issue

The National Pharmaceutical Regulatory Agency (NPRA) has received information from Health Canada on the risk of priapism associated with the use of propofol.⁴

In a safety review, Health Canada has reviewed one (1) local report and ten international published reports of priapism that were linked to the use of propofol-containing products. Majority of the reports (9) stated that the time to onset for priapism were between 5 minutes to 2 hours after propofol administration. Most of the reports (10) stated that the patients recovered after receiving treatment while one (1) reported a long-term disability.

Adverse Drug Reaction (ADR) Reports⁵

To date, the NPRA has received a total of 77 reports with 128 adverse events suspected to be related to propofol containing products. However, no ADR related to priapism following the use of propofol has been reported locally.

Advice for Healthcare Professionals

• Be alert on the risk of priapism associated with the use of propofol products.
• Low-flow (ischemic) priapism, which is commonly associated with drug use, is considered a medical emergency because irreversible damage may occur if not treated immediately. Early intervention allows the best chance for functional recovery.
• Report all suspected adverse events associated with the use of propofol products to the NPRA.

NPRA has completed a review of this safety issue and a directive [Ruj. Kami: NPRA 600-1/9/13(7)] has been issued for registration holders of propofol products to update the local package inserts to reflect this safety information.

References:

1. National Pharmaceutical Regulatory Agency. Malaysian Product Registration Database (Quest 3+). Propofol emulsion for injection or infusion local package insert [Internet]. Last revision date: 2018 October 15 [Cited 2020 August 18]. Available from: https://www.npra.gov.my
2. Vesta KS, Martina SD, Kozlowski EA. Propofol-induced priapism, a case confirmed with rechallenge. Annals of Pharmacotherapy [Internet]. 2006 May 1 [Cited on 2020 Aug 18]. 40(5):980-2. Available from: https://doi.org/10.1345/aph.1G555
3. Doherty AN, Khandhar PB. Propofol-associated priapism in a pediatric patient. Journal of Pharmacy Technology [Internet]. 2015 Apr [Cited on 2020 August 18]. 31(2):91-3. Available from: https://doi.org/10.1177/8755122514551419
4. Health Canada. Summary Safety Review – Propofol-containing products – Assessing the potential risk of prolonged erection of the penis (priapism) [Internet]. 2019 July 12 [Cited on 2020 August 18]. Available from: http://www.nanb.nb.ca/media/news/EN_Propofol_containing_products_priapism_SSR_PDF.PDF
5. National Pharmaceutical Regulatory Agency. The Malaysian National ADR Database [Internet]. 2020 [Cited 2020 June 15]. Available from: https://www.npra.gov.my

DISCLAIMER

This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While reasonable care has been taken to verify the accuracy of the information at the time of publication, the NPRA shall not be held liable for any loss whatsoever arising from the use of or reliance on this publication.