Thu, Jun 07, 2018 - Page 3 News List

FDA warns against increasing use of sedative propofol

By Lee I-chia  /  Staff reporter

The Food and Drug Administration (FDA) yesterday urged people to ensure that a certified anesthetist who can safely administer sedatives is present before signing an anesthesia consent form, as misuse of sedatives can lead to death.

While more clinics are using the term “comfortable-sleep” (舒眠) for patients undergoing an invasive examination or surgical procedure, the FDA said the term usually means being sedated with propofol, an intravenous anesthetic agent that makes the patient fall asleep rapidly.

Propofol is an opaque, white fluid, colloquially called “milk white injection” (乳白針) in many clinics, said Tsay Wen-ing (蔡文瑛), director of the FDA’s Division of Controlled Drugs.

It has been classified as a class four controlled drug in Taiwan since 2015, after several people died from propofol misuse around the world, including Michael Jackson.

The number of facilities registered to use propofol has increased one-and-a-half times in two years, from 1,149 in 2015 to 1,746 last year, with most of the new facilities being dental clinics, Tsay said.

Propofol is widely used for sedation because it works rapidly and afterward, patients feel like they have woken from a comfortable sleep, unlike the feeling they would get from other sedatives, Tungs’ Taichung MetroHarbor Hospital deputy superintendent and Department of Anesthesia physician Liaw Wen-jinn (廖文進) said.

However, as propofol only works for a short duration, sometimes an accidental overdose of injections during the examination or surgery can cause a patient to stop breathing and result in death, he said.

In 2012, a patient suffered an irregular heartbeat and sudden drop in blood pressure after receiving propofol for cosmetic surgery, and died after failed emergency treatment, Liaw said.

People who undergo examinations or surgeries should be asked to sign a anesthesia consent form, he said, adding that they should also ensure that the procedure is performed by a certified anesthetist, and that the clinic or hospital has a physiologic monitoring system and emergency rescue equipment,

The FDA is investigating clinics and pharmacies that have been using large amounts of propofol, and would deal with any cases of illegal usage according to the law, Tsay said.

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