ADR that result in revision of patient information
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| The United States: FDA Drug Safety Communication: Safety review update of codeine use in children; new Boxed Warning and Contraindication on use after tonsillectomy and/or adenoidectomy |
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The US Food and Drug Administration (FDA) is updating the public about new actions being taken to address a known safety concern with codeine use in certain children after tonsillectomy and/or adenoidectomy (surgery to remove the tonsils and/or adenoids). Deaths have occurred post-operatively in children with obstructive sleep apnea who received codeine for pain relief following a tonsillectomy and/or adenoidectomy. Codeine is converted to morphine by the liver. These children had evidence of being ultra-rapid metabolizers of codeine, which is an inherited (genetic) ability that causes the liver to convert codeine into life-threatening or fatal amounts of morphine in the body.
A new Boxed Warning, FDA’s strongest warning, will be added to the drug label of codeine-containing products about the risk of codeine in post-operative pain management in children following tonsillectomy and/or adenoidectomy. A Contraindication, which is a formal means for FDA to make a strong recommendation against use of a drug in certain patients, will be added to restrict codeine from being used in this setting. The Warnings/Precautions, Pediatric Use, and Patient Counseling Information sections of the drug label will also be updated.
Healthcare professionals should prescribe an alternate analgesic for post-operative pain control in children who are undergoing tonsillectomy and/or adenoidectomy. Codeine should not be used for pain in children following these procedures. For management of other types of pain in children, codeine should only be used if the benefits are anticipated to outweigh the risks. Parents and caregivers who observe unusual sleepiness, confusion, or difficult or noisy breathing in their child should stop giving codeine and seek medical attention immediately, as these are signs of overdose.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/DrugSafety/ucm339112.htm
In Hong Kong, there are 360 registered pharmaceutical products containing codeine and most of them are in syrup form. Codeine is an ingredient used to relieve pain and cough. So far, the Department of Health has not received any adverse drug reaction report in relation to the incident. On 16 August 2012, related news released by FDA has been posted on the website of Drug Office. Besides, a letter to inform healthcare professionals to draw their attention on the issue and urge them to report any adverse drug reaction related to the drug was issued as well. In connection with this development, the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Thursday, February 21, 2013
Issued at HKT 14:30
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