The Department of Pharmaceutical Affairs under the Executive Yuan's Department of Health announced today that strong painkillers containing Ketorolac, commonly used post-surgery (such as Ketorolac tablets and 26 other oral, injectable, and eye drop medications), may cause anaphylactic shock and even fatal reactions. As a result, manufacturers of Ketorolac-containing drugs have been required to add warning labels to their product inserts, reminding healthcare professionals to use these medications with caution.

Liao Jizhou, Director of the Department of Pharmaceutical Affairs, pointed out that Ketorolac-based painkillers are widely used in the medical field for strong post-surgical pain relief. To date, Taiwan has reported seven cases of anaphylactic shock following the injection of Ketorolac-containing medications, four of which resulted in death. Consequently, the Department of Pharmaceutical Affairs convened a meeting with experts and scholars to discuss the risk-benefit profile of Ketorolac-containing drugs.

Liao Jizhou stated that after discussions, experts generally agreed that Ketorolac-containing drugs remain clinically important for pain management. With careful and cautious use, adverse reactions can be prevented. It was decided that manufacturers must add warning labels to the product inserts, alerting healthcare professionals to the fact that Ketorolac-containing drugs have been associated with fatal anaphylactic shock cases. When using Ketorolac, emergency equipment should be prepared in advance, and patients should be monitored for safety within 30 minutes after injection.

Additionally, to prevent healthcare professionals from mistakenly using Ketorolac-containing drugs to reduce fever or lower body temperature, the Department of Pharmaceutical Affairs has also required that the product inserts include warnings against using these medications for fever reduction.

Source: http://www. udn. com/ 2008/ 1/ 10/ NEWS/ HEALTH/ HEA1/ 4175192. shtml