其 他 安 全 警 示
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| The United States: Zyvox (linezolid): Drug Safety Communication - serious CNS reactions possible when given to patients taking certain psychiatric medications (English Only) |
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FDA has received reports of serious central nervous system (CNS) reactions when the antibacterial drug linezolid (Zyvox) is given to patients taking psychiatric medications that work through the serotonin system of the brain (serotonergic psychiatric medications). A list of the serotonergic psychiatric medications that can interact with linezolid can be found in the Drug Safety Communication. Linezolid is used to treat infections, including pneumonia, infections of the skin, and infections caused by a resistant bacterium (Enterococcus faecium). It is a reversible monoamine oxidase inhibitor (MAOI). Although the exact mechanism of this drug interaction is unknown, linezolid inhibits the action of monoamine oxidase A — an enzyme responsible for breaking down serotonin in the brain. It is believed that when linezolid is given to patients taking serotonergic psychiatric medications, high levels of serotonin can build up in the brain, causing toxicity. This is referred to as Serotonin Syndrome — signs and symptoms include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination and/or fever. Safety information about this potential drug interaction and important drug usage recommendations for emergency and non-emergency situations are being added to the drug labels for serotonergic psychiatric medications and linezolid.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm265479.htm
In Hong Kong, Zyvox (linezolid) is registered by Pfizer Corp. HK Ltd., and is a prescription medicine. In view of FDA's recommendation, a letter to inform healthcare professionals will be issued and the matter will be discussed in the coming meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Wednesday, July 27, 2011
Issued at HKT 12:30
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