New Citalopram guidelines

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whopper

whopper

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Celexa (citalopram hydrobromide): Drug Safety Communication - Abnormal Heart Rhythms Associated With High Doses

AUDIENCE: Psychiatry, Cardiology

ISSUE: FDA notified healthcare professionals and patients that the antidepressant Celexa (citalopram hydrobromide) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart. Changes in the electrical activity of the heart (prolongation of the QT interval of the electrocardiogram [ECG]) can lead to an abnormal heart rhythm (including Torsade de Pointes), which can be fatal. Patients at particular risk for developing prolongation of the QT interval include those with underlying heart conditions and those who are predisposed to low levels of potassium and magnesium in the blood.

Studies did not show a benefit in the treatment of depression at doses higher than 40 mg per day. Previously, the citalopram drug label stated that certain patients may require a dose of 60 mg per day. The citalopram drug label has been revised to include the new drug dosage and usage recommendations, as well as information about the potential for QT interval prolongation and Torsade de Pointes. See the FDA Drug Safety Communication Data Summary for additional information.

BACKGROUND: Celexa (citalopram hydrobromide) is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs).

RECOMMENDATION: Citalopram causes dose-dependent QT interval prolongation. Citalopram should no longer be prescribed at doses greater than 40 mg per day. Citalopram should not be used in patients with congenital long QT syndrome. Patients with congestive heart failure, bradyarrhythmias, or predisposition to hypokalemia or hypomagnesemia because of concomitant illness or drugs, are at higher risk of developing Torsade de Pointes. See the FDA Drug Safety Communication for additional recommendations for healthcare professionals and 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
Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/...tyAlertsforHumanMedicalProducts/ucm269481.htm
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I just got this from a pharmacy in one of the hospitals I work in. Nuts, I got so many patients doing great on Citalopram 60 mg Qdaily and did better on 60 vs. 40 mg.
 
So should we start getting EKGs before starting Celexa now? If so, it'll be such a shame, it was a very easy and cheap med to use.
 
Thanks for the post Whopper. I was just about to bump my OCD patient from Citalopram 40mg to 60mg. 😱. I decided to keep the SSRI the PCP started (20mg), increasing it, and starting CBT. I'm wondering if I should just switch SSRI's now or keep the Citalopram at 40mg and continue charging through with CBT...😕
 
This is rediculous. The low drug drug reactivity of celexa makes it a staple in use with cardiac patients. I wonder what data they are using to make this claim. It could be possible selection bias that the patients were merely predisposed based on condition rather than medication. I want to know the evidence or if this is just case report conjecture!

However, I should note I've yet to push anyone past 40mg anyways. But if this blanket warning is on the medication it will impede a good medicine for appropriate patients. Still upsetting.
 
Sneezing said:
This is rediculous. The low drug drug reactivity of celexa makes it a staple in use with cardiac patients. I wonder what data they are using to make this claim. It could be possible selection bias that the patients were merely predisposed based on condition rather than medication. I want to know the evidence or if this is just case report conjecture!

However, I should note I've yet to push anyone past 40mg anyways. But if this blanket warning is on the medication it will impede a good medicine for appropriate patients. Still upsetting.
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I agree with you. I'd be willing to bet it is based off of poor data and/or case reports. There is plenty of patients that show improvement on >40mg of Celexa, and I've never seen any significant QT prolongation. Heck, eating a meal prolongs QT interval. I guess eating should be considered a cardiac risk - oh wait.....look at all the obese people around.
 
whopper said:
I just got this from a pharmacy in one of the hospitals I work in. Nuts, I got so many patients doing great on Citalopram 60 mg Qdaily and did better on 60 vs. 40 mg.
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On a sort of related note, does psych typically perform routine EKGs on patients who take TCAs in the higher dose range? In particular, I'm thinking of Elavil. I have one patient who usually has a mild sinus tach while on a dose of 200 mg (obviously I did an EKG, and obviously in this case it was for a reason - i.e. tachycardia).
 
ghost dog said:
On a sort of related note, does psych typically perform routine EKGs on patients who take TCAs in the higher dose range? In particular, I'm thinking of Elavil. I have one patient who usually has a mild sinus tach while on a dose of 200 mg (obviously I did an EKG, and obviously in this case it was for a reason - i.e. tachycardia).
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Neurology uses TCA more than psychiatry, as far as I am aware. TCAs really are no longer first line for anything. But, for the few who are on TCA I am not aware of anyone doing routine EKG.
 
I guess this applies to escitalopram as well?
 
mo1ly said:
I guess this applies to escitalopram as well?
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just Citalopram from what I've read so far.

I rarely go that high with it, but will jus start treating it as I do Geodon, Orap, and others- informed consent and ekg's. Document your reasoning and you will be fine.
 
OK, now I'm really scared. I have been on Celexa 60mg for a long time now. I have a Dr's appt on Tuesday, but what if something happens to me before we can change my dosage?

Am I being to Paranoid about this?
 
Kbaxter77 said:
OK, now I'm really scared. I have been on Celexa 60mg for a long time now. I have a Dr's appt on Tuesday, but what if something happens to me before we can change my dosage?

Am I being to Paranoid about this?
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Sorry, but SDN cannot even come close to giving you any advice, suggestions, warning or comfort about your own treatment.
We have to refer you to your provider or whoever is on-call for your provider.
 
I figure there's a few way to go about this.

One option is to rarely ever go above 40 mg Qdaily and start adding augmentation agents after that such as Buspirone, but only if need be.

Another option is to still opt to go to 60 mg Qdaily but be more open to doing EKGs and getting patient consent with full disclosure that you're not following FDA guidelines.

Other option, steer clear away from Citalopram as a first-line. Go with Sertraline first, especially with the anxiety disorders that warrant higher dosages of SSRIs such as OCD.

The thing that rubs me the wrong way about this is Citalopram has been out for decades and in several studies, tends to be much lower in the odds of getting side effects vs other SSRIs with the exception of Lexapro. Given that, why is this data coming out now when other data suggest its less likely to have side effects vs. other SSRIs? Why only after decades of it being out with me having no problems giving it out to patients at 60 mg Qdaly?

Way back before CATIE came out, and it exposed Seroquel as being the worst offender for QT prolongation, not Geodon, among the atypicals, I have seen a few people be on Serouqel and get cardiac side effects such as palpitations, a feeling as if their heart was racing, and EKGs strongly suggesting that the Seroquel be stopped. Not surprising. CATIE was a good study, and from personal experience, the results from that study have been consistent with what I've seen in real clinical practice. Now a report comes out flying in the face of other data, and what I've seen in clinical practice, and I don't see the source of data from that report, though it's the FDA and the FDA is considered a reputable source.

I think I'm going to get a lot of patients on 60 mg Qdaily of Citalopram to 40 mg Qdaily because of this data, and a lot of them are going to get worse with no evidence of any problems on 60 mg Qdaily.
 
Last edited:
does anyone know the study that put these new guidelines in place?
 
Have any of you guys had a problem getting a script fo 60 mg total of celexa filled by an outpatient pharmacy since the new guidelines? One of our attendings was told by a store pharmacist that they could no longer provide this dose. I'm hoping that it was just that one pharmacist or pharmacy policy, but I wanted to get input from you guys. Does this new guideline actually put fixed limits on the use or just reccomend against it like the old don't use atypicals in elderly dementia patients?
 
Scorcher31 said:
Have any of you guys had a problem getting a script fo 60 mg total of celexa filled by an outpatient pharmacy since the new guidelines? One of our attendings was told by a store pharmacist that they could no longer provide this dose. I'm hoping that it was just that one pharmacist or pharmacy policy, but I wanted to get input from you guys. Does this new guideline actually put fixed limits on the use or just reccomend against it like the old don't use atypicals in elderly dementia patients?
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There should not be a problem. Scripts are still being filled here.
 
According to the local STAR*D expert, lexapro so far has been NEGATIVE for QT. I'm starting to wonder if there's some pharma ploy in this.
 
I had a problem with getting 60mg dispensed by a pharmacy, actually they refused to fill it at that dose due to 'liability' issues :shrug:
 
very troubling. Faculty here basically fell in line and no more above 40 anymore, but wonder what they are doing with outpts currently on dosages over 40. I assume they will run and hide and fall in line relatively soon. Welcome to the algorithm, I feel 'we' deserve it sometimes.
 
What I've been doing in informing patients of the new FDA guidelines, but also telling them that Citalopram has been available at 60 mg Qdaily for decades any only now without mentioning the source of data the FDA is now saying no more than 40 mg Qdaily, I tell patients I will provide 60 mg Qdaily only if they believe it provided them superior benefit to 40 mg Qdaily and they are aware that per the FDA is raises the risk of an arrhythmia, and if they are on more than 40 mg Qdaily I offer them an EKG that I tell them I will not force them to take. So far everyone single person on 60 mg Qdaily refused an EKG.

I also tell the patient that I could offer them a different antidepressant, lower their dosage to 40 mg Qdaily and if they get worse we could augment it or put them back on 60 mg Qdaily.

I leave it up to them. So far almost every single person decided to stay on 60 mg Qdaily. A few opted to go to 40 mg Qdaily but not because of fear of arrhythmia. Those people just wanted to see if they could be maintained on a lower dosage of antidepressant after showing successful treatment for several months.
 
Just got nailed at the VA for increasing Citalopram from 20mg to 40mg in a 60 y/o pt.

Per the FDA:

"20 mg per day is the maximum recommended dose for patients with hepatic impairment, who are greater than 60 years of age, who are CYP 2C19 poor metabolizers, or who are taking concomitant cimetidine (Tagamet®), because these factors lead to increased blood levels of citalopram, increasing the risk of QT interval prolongation and Torsade de Pointes."

I was aware of the 40mg max several months ago, but not sure when they added the 20mg max in special populations. Citalopram is gettin' a beatin'!
 
PETRAN said:
What about Escitalopram?
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OldPsychDoc said:
So does anyone else smell a rat in the Forest? 🙄
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LOL.

mo1ly said:
I guess this applies to escitalopram as well?
Click to expand...

sluox said:
According to the local STAR*D expert, lexapro so far has been NEGATIVE for QT. I'm starting to wonder if there's some pharma ploy in this.
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From http://www.qtdrugs.org/:

[FONT=Arial, Helvetica, sans-serif]Generic Name.
[FONT=Arial, Helvetica, sans-serif]Escitalopram. [FONT=Arial, Helvetica, sans-serif]PubMed Search. [FONT=Arial, Helvetica, sans-serif]Brand Name(s).
[FONT=Arial, Helvetica, sans-serif] Cipralex® ,Lexapro® . [FONT=Arial, Helvetica, sans-serif]Drug Class.
[FONT=Arial, Helvetica, sans-serif]Anti-depressant.


[FONT=Arial, Helvetica, sans-serif]QT.


[FONT=Arial, Helvetica, sans-serif]TdP.


[FONT=Arial, Helvetica, sans-serif]Risk Group.
[FONT=Arial, Helvetica, sans-serif]A drug that may prolong the QT interval but at this time lacks substantial evidence for causing Torsades de Pointes. This drug should be avoided for use in patients with diagnosed or suspected Congenital Long QT Syndrome..
[FONT=Arial, Helvetica, sans-serif]Comments.
[FONT=Arial, Helvetica, sans-serif]data2
.

If Lexapro is the enantiomer of Celexa, how could this not also be a problem?

I'm pretty sure Lexapro is now generic this month.
 
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