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  1. Drug Safety and Availability

FDA Drug Safety Communication: Updated information about the drug interaction between linezolid (Zyvox) and serotonergic psychiatric medications

This update is in follow-up to the FDA Drug Safety Communication posted on 7/26/2011: Serious CNS reactions possible when linezolid is given to patients taking certain psychiatric medications.

Safety Announcement

[10/20/2011] The U.S. Food and Drug Administration (FDA) is updating the public on the potential drug interaction between linezolid and serotonergic psychiatric medications.

FDA is providing additional information about the reports of serotonin syndrome. 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) (see section I). 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 (see section II).

FDA will update the public when new information is available.

I. Serotonergic psychiatric drugs implicated in the AERS cases of serotonin syndrome with linezolid

Selective Serotonin Reuptake Inhibitors (SSRIs)

 Generic Name Found in Brand Names 
paroxetine Paxil, Paxil CR
fluvoxamine Luvox, Luvox CR
fluoxetine Prozac, Symbyax
sertraline Zolort
citalopram Celexa
escitalopram Lexapro
vilazodone1   Viibryd

1Although the FDA has not received cases of serotonin syndrome to date involving vilazodone, the pharmacology of this drug places it in the SSRI category and suggests that it possesses a risk comparable to that of the SSRIs.

Serotonin Norepinephrine Reuptake Inhibitors (SNRIs)

 

Generic Name Found in Brand Names     
venlafaxine Effexor, Effexor XR
desvenlafaxine Pristiq
duloxetine Cymbalta

 

II. Other psychiatric drugs with varying degress of serotonergic activity for which the risk of serotonin syndrome with linezolid is unclear


Tricyclic Antidepressants (TCAs)

 

Generic Name Found in Brand Names    
clomipramine               Anafranil
amitriptyline Amitid, Amitril, Elavil, Endep, Etrafon,        
Limbitrol, Triavil
desipramine Norpramin, Pertofrane
imipramine Tofranil, Tofranil PM, Janimine,
Pramine, Presamine
nortriptyline Pamelor, Aventyl hydrochloride
protriptyline Vivactil
doxepin Sinequan, Zonalon, Silenor
trimipramine                     Surmontil

 

Monoamine Oxidase Inhibitors (MAOIs)

 

Generic Name Found in Brand Names
isocarboxazid            Marplan                                            
phenelzine Nardil
transdermal selegiline Emsam
tranylcypromine Parnate

 

 
Other Psychiatric Medications

 

Generic Name Found in Brand Names
amoxapine                      Asendin
maprotiline Ludiomil
nefazodone Serzone
trazodone Desyrel, Oleptro, Trialodine
bupropion Wellbutrin, Wellbutrin SR, Wellbutrin XL,
Aplenzin
buspirone Buspar
mirtazapine Remeron, Remeron Soltab

 

 

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