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FDA, 2011 Zyvox (linezolid): Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications


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The article can be foundHERE

 

Zyvox (linezolid): Drug Safety Communication - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications

[uPDATED 10/21/2011] The FDA updated information on the potential drug interaction between linezolid and serotonergic psychiatric medications. Not all serotonergic psychiatric drugs have an equal capacity to cause serotonin syndrome with linezolid. Most cases from the FDA's Adverse Event Reporting System (AERS) of serotonin syndrome with linezolid occurred in patients taking specific serotonergic psychiatric drugs, namely a selective serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI). It is unclear at this time whether linezolid administration in patients receiving other psychiatric drugs with lesser degrees of serotonergic activity poses a comparable risk.

 

FDA will update the public when new information is available.

 

[Posted 07/26/2011]

 

AUDIENCE: Infectious Disease, Psychiatry, Family Practice

 

ISSUE: 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. 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.

 

BACKGROUND: 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.

 

A separate Drug Safety Communication (DSC) is being released today for methylene blue due to similar potential drug interactions with serotonergic psychiatric medications and includes drug usage recommendations.

 

RECOMMENDATION: Linezolid should generally not be given to patients taking serotonergic drugs. However, there are some conditions that may be life-threatening or require urgent treatment with linezolid such as when:

 

Linezolid is used to treat vancomycin-resistant Enterococcus faecium (VRE) infections.

Linezolid is used to treat infections such as nosocomial pneumonia and complicated skin and skin structure infections, including cases caused by methicillin-resistant Staphylococcus aureus (MRSA).

 

Patients should not stop taking their serotonergic psychiatric medicine without first talking to a healthcare professional. Read the Drug Safety Communication for other specific recommendations for Healthcare Professionals and for Patients.

 

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[10/21/2011 - Drug Safety Communication Update - FDA]

[07/26/2011 – Drug Safety Communication - FDA]

Fall 1995 xanax, zoloft. switched to Serzone

1996- spring 2003serzone/ xanax/ lightbox.

b]Fall 2003- Fall 2004? Lexapro 10 mg. Light box /4 mg. xanax.[/b]

2004 - Fall of 2009 10 mg Lex, 150 mg Wellbutrin XL % 4 mg xanax

November 2009- Sept. 2011 10 mg lex., 300 Well. XL, 4 mg Xanax [/b

Sept.2012- July 2012 20 mg Lex 300 Well. XL, 4 mg Xanax

My mantra " go slow & with the flow "

3/2/13.. Began equal dosing 5 Xs /day xanax, while simultaneously incorporating a 2.5 % drop ( from 3.5 mg/day to 3.4 mg/day)

4/6/13 dropped from 300 mg. Wellbutrin XL to 150 mg. Difficult but DONE! Down to 3.3 mg xanax/ day / 6/10/13 3 mg xanax/day; 7/15/2013 2.88mg xanax/day.

10/ 1/2013...... 2.5 mg xanax… ( switched to tablets again) WOO HOO!!!!!! Holding here… cont. with Lexapro.

1/ 2/2014.. tapered to 18mg ( by weight) of a 26 mg ( by weight) pill of 20 mg tab. lexapro. goal is 13mg (by weight OR 10 mg by ingredient content) and STOPPED. Feeling very down with unbalanced, unpredictable WD symptoms.

1/2/2014- ??? Taking a brain-healing break from tapering anything after actively tapering something for 1.5 years. So… daily doses as of 2/2/2014: 18 mg by weight Lex, 150 mg Well. XL, 2.5 mg xanax, down from 26 mg by weight Lex., 300 mg well. XL, 4 mg xanax in August, 2012. I'll take it. :) 5/8/14 started equivalent dose liquid./ tabs. 5/13/14 1.5 % cut.

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Good info. I had no idea this antibacterial was an MAO inhibitor.

Pristiq tapered over 8 months ending Spring 2011 after 18 years of polydrugging that began w/Zoloft for fatigue/general malaise (not mood). CURRENT: 1mg Klonopin qhs (SSRI bruxism), 75mg trazodone qhs, various hormonesLitigation for 11 years for Work-related injury, settled 2004. Involuntary medical retirement in 2001 (age 39). 2012 - brain MRI showing diffuse, chronic cerebrovascular damage/demyelination possibly vasculitis/cerebritis. Dx w/autoimmune polyendocrine failure.<p>2013 - Dx w/CNS Sjogren's Lupus (FANA antibodies first appeared in 1997 but missed by doc).

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  • Administrator

Thanks, areyouthere.

 

I moved this warning to Symptoms because it will get more attention here, and people often ask what antibiotics would be a problem in this forum.

This is not medical advice. Discuss any decisions about your medical care with a knowledgeable medical practitioner.

"It has become appallingly obvious that our technology has surpassed our humanity." -- Albert Einstein

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