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FDA Drug Safety Communication: Serious CNS reactions possible when linezolid (Zyvox) is given to patients taking certain psychiatric medications
Safety Announcement
Additional Information for Patients
Additional Information for Healthcare Professionals
Data Summary
References
Safety Announcement
[07-26-2011] The U.S. Food and Drug Administration (FDA) has received reports of rious central nervous system (CNS) reactions when the antibacterial drug linezolid (marketed as Zyvox) is given to patients taking psychiatric medications that work through the rotonin system of the brain (rotonergic psychiatric medications).
A list of the rotonergic psychiatric medications that can interact with linezolid can be found here.
Although the exact mechanism of this
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interaction is unknown, linezolid
A—an enzyme responsible for breaking
down rotonin in the brain. It is
patients taking rotonergic
medications, high levels of rotonin
This is referred to as Serotoninthe roommate
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.
Healthcare professionals and patients may not realize that linezolid has monoamine oxida inhibitor (MAOI) properties. Linezolid should generally not be given to patients taking rotonergic drugs. However, there are some conditions that may be life-threatening or require urgent treatment with linezolid such as when:
∙Linezolid is ud to treat vancomycin-resistant Enterococcus faecium (VRE) infections.
∙Linezolid is ud to treat infections such as nosocomial pneumonia and complicated skin and skin structure infections, including cas caud by methicillin-resistant
Staphylococcus aureus (MRSA).
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 rotonergic psychiatric medications and linezolid (Zyvox). (See Additional Information for Healthcare Professionals)
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A parate Drug Safety Communication (DSC) is being relead today for methylene blue1 due to similar potential drug interactions with rotonergic psychiatric medications and includes drug usage recommendations.
Additional Information for Patients
∙Y ou may need to temporarily stop taking your rotonergic psychiatric medication if it becomes necessary for you to take linezolid in certain situations. Y our healthcare provider will tell you when to start linezolid after stopping your rotonergic psychiatric
medication.
∙Do not stop taking your rotonergic psychiatric medicine without first talking to a healthcare professional.
∙Make sure your healthcare professional knows about all the medications you are taking. It is helpful to keep a list of all your current medications in your wallet or another location
where it is easily retrieved.practi
∙Contact your healthcare professional immediately if you are taking a rotonergic psychiatric medication and develop any of the following symptoms: mental changes
(confusion, hyperactivity, memory problems), muscle twitching, excessive sweating,
shivering or shaking, diarrhea, trouble with coordination, and/or fever.
∙Discuss any questions or concerns about linezolid or rotonergic psychiatric medications with your healthcare professional.
∙Report any rious side effects you experience to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of the page.
Additional Information for Healthcare Professionals
∙Linezolid (Zyvox) can interact with rotonergic psychiatric medications and cau rious CNS toxicity.
∙In emergency situations requiring life-threatening or urgent treatment with linezolid (as described above), the availability of alternative interventions should be considered and
the benefit of linezolid treatment should be weighed against the risk of rotonin toxicity.
If linezolid must be administered to a patient receiving a rotonergic drug, the
rotonergic drug must be immediately stopped and the patient should be cloly
monitored for emergent symptoms of CNS toxicity for two weeks (five weeks if
fluoxetine [Prozac] was taken), or until 24 hours after the last do of linezolid,
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whichever comes first.
bookdown∙In non-emergency situations when non-urgent treatment with linezolid is contemplated and planned, the rotonergic psychiatric medication should be stopped, to allow its
activity in the brain to dissipate. Most rotonergic psychiatric drugs should be stopped at least 2 weeks in advance of linezolid treatment. Fluoxetine (Prozac), which has a longer
half-life compared to similar drugs, should be stopped at least 5 weeks in advance.
∙Treatment with the rotonergic psychiatric medication may be resumed 24 hours after the last do
of linezolid.
∙Serotonergic psychiatric medications should not be started in a patient receiving linezolid.
Wait until 24 hours after the last do of linezolid before starting the antidepressant.
∙Educate your patients to recognize the symptoms of rotonin toxicity or CNS toxicity and advi them to contact a healthcare professional immediately if they experience any
symptoms while taking rotonergic psychiatric medications or linezolid.
∙Report adver events involving linezolid or rotonergic psychiatric medications to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of the page.
Data Summary
FDA has received adver event reports from the FDA Adver Event Reporting System (AERS) databa involving cas in which rotonin syndrome was associated with the concomitant administration of linezolid and a rotonergic psychiatric medication. Some deaths were reported. The literature arch identified additional ca reports, including at least 1 ca with a fatal outcome.1
Bad on the available information provided in the AERS cas and literature, FDA has concluded that the concomitant administration of a rotonergic psychiatric medication with linezolid has the potential for a drug interaction causing rotonin syndrome. It appears this potential drug interaction can also occur following the discontinuation of rotonergic psychiatric medications with long half-lives. As a result, linezolid should generally not be given to patients taking rotonergic drugs unless the benefit is deemed to outweigh the risk.
References
1.Clark DB, Andrus MR, Byrd DC. Drug interactions between linezolid and lective
rotonin reuptake inhibitors: ca report involving rtraline and review of the literature.
Pharmacotherapy. 2006;26:269-76.bonny
Tables -Psychiatric medications with rotonergic activity
我好想你韩语怎么说Selective Serotonin Reuptake Inhibitors (SSRIs)
Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs)
Tricyclic Antidepressants (TCAs)
Monoamine Oxida Inhibitors (MAOIs)
Other Psychiatric Medications
