Other safety alerts
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| The United States: Tramadol: Drug Safety Communication - FDA evaluating risks of using in children aged 17 and younger |
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FDA is investigating the use of the pain medicine tramadol in children aged 17 years and younger, because of the rare but serious risk of slowed or difficult breathing. This risk may be increased in children treated with tramadol for pain after surgery to remove their tonsils and/or adenoids. FDA is evaluating all available information and will communicate final conclusions and recommendations to the public when the review is complete.
Tramadol is not FDA-approved for use in children; however, data show it is being used “off-label” in the pediatric population. Health care professionals should be aware of this and consider prescribing alternative FDA-approved pain medicines for children.
In the body, tramadol is converted in the liver to the active form of the opioid, called O-desmethyltramadol. Some people have genetic variations that cause tramadol to be converted to the active form of the opioid faster and more completely than usual. These people, called ultra-rapid metabolizers, are more likely to have higher-than-normal amounts of the active form of the opioid in their blood after taking tramadol, which can result in breathing difficulty that may lead to death. Recently, a 5-year-old child in France experienced severely slowed and difficult breathing requiring emergency intervention and hospitalization after taking a single prescribed dose of tramadol oral solution for pain relief following surgery to remove his tonsils and adenoids. The child was later found to be an ultra-rapid metabolizer and had high levels of O-desmethyltramadol in his body.
Parents and caregivers of children taking tramadol who notice any signs of slow or shallow breathing, difficult or noisy breathing, confusion, or unusual sleepiness should stop tramadol and seek medical attention immediately.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm463499.htm
In Hong Kong, there are 43 registered pharmaceutical products containing tramadol. All are prescription-only medicines. So far, the Department of Health (DH) has received 2 cases of adverse drug reaction (ADR) on tramadol, and none of them was related to slowed or difficult breathing. In view of the US FDA is evaluating the available information and will draw a final conclusion and recommendations to the public when the review is complete, the DH will remain vigilant on the final conclusion made by the US FDA.
Ends/ Tuesday, September 22, 2015
Issued at HKT 13:00
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