其 他 安 全 警 示
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| Australia: Minocycline and agranulocytosis (English only) |
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The Therapeutic Goods Administration (TGA) announces that health professionals are advised that the Product Information (PI) for minocycline is in the process of being updated to include information about agranulocytosis, a rare but potentially life-threatening adverse event.
Cases of agranulocytosis have been reported to the TGA following treatment with minocycline. As at 25 Aug 2021, the TGA had recorded reports of 4 cases for minocycline involving agranulocytosis. One case had a positive de-challenge while another was a fatal case reported as tetracycline-induced agranulocytosis. In the other 2 cases, minocycline-induced agranulocytosis could not be ruled out, as the cases were confounded by other medicines known to cause agranulocytosis.
Agranulocytosis is a serious condition that occurs when there is an extremely low number of granulocytes (a type of white blood cell) in the blood. Signs and symptoms of agranulocytosis include fever, chills, weakness, sore throat, sores in the mouth or throat, bleeding gums, bone pain, low blood pressure, fast heartbeat, and trouble breathing. People with this condition are at very high risk of serious infections due to their suppressed immune system.
Agranulocytosis is a rare but serious condition with a reported incidence ranging from 1 to 5 cases per million population per year. An association with medication use can be found in about 70% of cases.
Prescribers should be aware of the potential risk of agranulocytosis associated with minocycline and the importance of early recognition and monitoring of full blood count and liver function tests during treatment. Prior to treatment with minocycline, patients should be made aware of the risk, including signs and symptoms, and what to do in the event of suspected agranulocytosis.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/publication/minocycline-and-agranulocytosis
In Hong Kong, there are 2 registered pharmaceutical products containing minocycline. Both products are prescription-only medicines. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to minocycline. The risk of agranulocytosis associated with the use of tetracycline antibiotics (including minocycline) is documented in overseas reputable drug references such as the “Martindale: The Complete Drug Reference”. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Tuesday, Aug 31, 2021
Issued at HKT 15:30
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