# Zofran



## EMS Patient Care Advocate (Sep 20, 2011)

http://www.fda.gov/Drugs/DrugSafety/ucm271913.htm

Zofran warning. Medicine is strange.


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## jjesusfreak01 (Sep 20, 2011)

Well, I can't think of a safer place to go into Torsades than the back of an ambulance


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## nhvtmedic (Sep 20, 2011)

actually prolonged QT is one of the most commonly listed side effects of Zofran. I personally have never seen it but have heard about it plenty


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## EMS Patient Care Advocate (Sep 20, 2011)

amerelman said:


> actually prolonged QT is one of the most commonly listed side effects of Zofran. I personally have never seen it but have heard about it plenty



Why all of a sudden a big FDA warning?


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## Katy (Sep 20, 2011)

I'm not particularly surprised. All medicines have possible side affects, they just seemed to have discovered a possibly fatal one for Zofran.


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## daj72 (Sep 20, 2011)

In Denmark the arrhythmia is a know, but is categorized as a "rare" side effect(0,1-1%).

"Use of ondansetron with drugs that prolong the QT interval may result in additional QT prolongation. Concomitant use of ondansetron with cardio-toxic drugs (eg anthracyclines) may increase the risk of arrhythmias." from a danish meds. health site.

Personally I have never seen it, when I´m giving Zofran.


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## nhvtmedic (Sep 20, 2011)

maybe they started seeing it more recently. I had heard of it since we studied it in medic school


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## EMS Patient Care Advocate (Sep 20, 2011)

So what do we think is safer, Zofran or Reglan ?


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## nhvtmedic (Sep 20, 2011)

I don't think Zofran is any less safe then it has always been. The number of side effects i've seen from Zofran is minimal. I would still say Zofran over Reglan safety-wise but both are effective medications.


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## usafmedic45 (Sep 20, 2011)

EMS Patient Care Advocate said:


> Why all of a sudden a big FDA warning?



Because they put them out all the damn time for stuff. Take a breath and stop making a mountain out of a mole hill. You seem to have a habit of doing that, most likely due to a lack of experience.


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## Anjel (Sep 21, 2011)

usafmedic45 said:


> Take a breath and stop making a mountain out of a mole hill.



Same to you


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## usafmedic45 (Sep 21, 2011)

Anjel1030 said:


> Same to you



:unsure:


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## systemet (Sep 21, 2011)

EMS Patient Care Advocate said:


> Why all of a sudden a big FDA warning?



Well, the link doesn't specify why.  My best guess would be that there's be a large enough number of cases of QT prolongation with Zofran that the FDA decided it would be wise to place a more detailed warning on the packaging, and send out the warning.

There was a similar issue, if I recall, with droperidol, a few years back.

It will be interesting to see if this changes anyone's practice, whether people start measuring the QTc before giving Zofran.


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## EMS Patient Care Advocate (Sep 21, 2011)

systemet said:


> Well, the link doesn't specify why.  My best guess would be that there's be a large enough number of cases of QT prolongation with Zofran that the FDA decided it would be wise to place a more detailed warning on the packaging, and send out the warning.
> 
> There was a similar issue, if I recall, with droperidol, a few years back.
> 
> It will be interesting to see if this changes anyone's practice, whether people start measuring the QTc before giving Zofran.



You hit on the reason I tossed this out to everyone. Is this warning enough of a concern that you would withold zofran with long QT patients? Or if more caution may be used with patients on other high risk medications that cause a prolonged QT?


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## systemet (Sep 21, 2011)

EMS Patient Care Advocate said:


> You hit on the reason I tossed this out to everyone. Is this warning enough of a concern that you would withold zofran with long QT patients?



Absolutely.  Based on the information provided, I'd withhold it on anyone with a long QT.  I would do the same with droperidol.  There are other antiemetics that don't prolong the QT.

The question is whether people will modify their practice to begin performing ECGs prior to giving Zofran, and whether medical direction will require this.  Because otherwise you're not going to identify a lot of people with prolonged QT intervals.




> Or if more caution may be used with patients on other high risk medications that cause a prolonged QT?



I think I would be cautious in this situation as well.  However, given the very long list of additional medications that can extend the QT interval, the question is going to be whether the average paramedic is going to be aware of the risk for medication interaction.  It's not like people are going to have this list memorised.

It also depends how you define the word "cautious".  Is "cautious" giving the medication, and then checking the QTc at 5 minutes? 20 minutes?  Or is it just keeping in the back of your mind that ECG changes may occur?  Does it mean mandating ECG-monitoring post-Zofran?

I'm honestly not sure what I would do.  I'm not currently working EMS.  I think if I was, I'd send an email to my medical director.


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## EMS Patient Care Advocate (Sep 21, 2011)

usafmedic45 said:


> Because they put them out all the damn time for stuff. Take a breath and stop making a mountain out of a mole hill. You seem to have a habit of doing that, most likely due to a lack of experience.



Stopping to take a breath is always great advice. I do lack experience. I have been a paramedic for only 2 years on Sept 11th (oddly enough). So where YOU may see this "stuff" all the time, I have been watching and caring for only about 2 years. 

I'm certain they do come "out with this stuff all the damn time" though. Medicine is ever evolving. I am a sole paramedic in the middle of nowhere, and my partner is commonly only a driver with no medical training. I don’t get to work with other paramedics. So it was exciting to find a place to bounce thoughts and ideas- here. I was also thinking this would be a positive learning environment. So if a question bothers you or seems silly, I'm sorry, I don’t mean to complicate anything or make it more than it has to be, but I do like to be thorough.

I always want opinions or I would have no way of learning from my mistakes, or know when I made the right decisions in the first place. 

It IS too bad that I have spent conversation about my lack of experience and written a long post that is of no medical benifit to anyone.


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## EMS Patient Care Advocate (Sep 21, 2011)

systemet said:


> The question is whether people will modify their practice to begin performing ECGs prior to giving Zofran, and whether medical direction will require this.  Because otherwise you're not going to identify a lot of people with prolonged QT intervals.
> .



Well, I know I am performing EKGs on MOST (not all) patients these days anyways. For this area 12 leads and Zofran are standing orders. Shooting a few 12s lead I don’t think would be a bad idea. Not everyone is in the same situation but I know sometimes my 911 transports are 30 min and Zofran may be the only medication I’m administering. I doubt it will be required-well at least not until the FDA says so, but I usually do a lot more than what is required for my patients. Plus it gives me an excuse to collect and read more 12 leads. 

I think by caution I mean take into consideration, weigh risk vs gain. If this means I need to keep a card with 50 long QT medications on it, I will (and prolly should anyways)- Im really only concerned about HIGHer risk medications, the less chances of adding a long QT medication onto another the better I would think.


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## systemet (Sep 21, 2011)

A complete list would be a lot more than 50 medications, as you can see here: http://www.qtdrugs.org/

I agree that taking an approach to identifying "high risk" medications would be better.  

I also think you could measure a QTc reasonably with just using the limb leads, without having to do a 12-lead.  But if you're doing one already, then you have the information there.


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## 8jimi8 (Sep 21, 2011)

I asked our ICU pharmacist about the risk quite a while back because my girlfriend takes zofran quite regularly.  Unless you are administering more than 40mg at a time, she said there is not much of a risk.



Ondansetron is a standard comfort order along with phenergan that comes on EVERY ICU pt order set.    

Would I hesitate with someone with a qtc of > .49?  Depends on how much they are vomiting and why?



Funny... We gave it for the nausea on a STEMI pt with a balloon pump awaiting cabg.  No torsades there...  Although he did have a vf/vt/Brady arrest once we pulled that balloon!


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## usalsfyre (Sep 21, 2011)

Seems like droperidol all over again. Perhaps the FDA should focus on educating the public that medications are chemicals that alter normal physiology and occasionally untoward side effects happen because of that rather than the constant stream of "oh my God's" everytime a couple of adverse events occur. 

That of course would force people to take some responsibility and an active role in their own health, so it ain't gonna happen.


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## medicdan (Sep 21, 2011)

There's some discussion on medical blogs that this is a result of Zofran going generic-- it's been on the market 20 years and GSK just came across this single-center study... and wants to threaten it's generic competitors. 

http://drwes.blogspot.com/2011/09/f...pot/TuRAx+(Dr.+Wes)&utm_content=Google+Reader

http://www.epmonthly.com/whitecoat/2011/09/fda-zofran-may-be-deadly/


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## EMS Patient Care Advocate (Sep 21, 2011)

emt.dan said:


> There's some discussion on medical blogs that this is a result of Zofran going generic-- it's been on the market 20 years and GSK just came across this single-center study... and wants to threaten it's generic competitors.
> 
> http://drwes.blogspot.com/2011/09/f...pot/TuRAx+(Dr.+Wes)&utm_content=Google+Reader
> 
> http://www.epmonthly.com/whitecoat/2011/09/fda-zofran-may-be-deadly/



Good reads, thanks. Follow the money as I have been told.


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## 18G (Sep 21, 2011)

Prolonged QT has always been a part of the cautions for Zofran although reported at an extremely low incidence. 

Perhaps now that the drug is administered so widely and as a first line antiemetic with the generic, the cardiac issue is being reported more with increased use of the drug?

One of the great things with Zofran has always been its safety profile and virtually no side effects. The caution is definitely worth noting at least.


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## 8jimi8 (Sep 21, 2011)

18G said:


> Prolonged QT has always been a part of the cautions for Zofran although reported at an extremely low incidence.
> 
> Perhaps now that the drug is administered so widely and as a first line antiemetic with the generic, the cardiac issue is being reported more with increased use of the drug?
> 
> One of the great things with Zofran has always been its safety profile and virtually no side effects. The caution is definitely worth noting at least.



Typically we use it 2nd line behind phenergan.  But the frequency is also noted to be 4mg q6


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## Katy (Sep 21, 2011)

I think from most people I know, they tend to use Phenergan as well.


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## 18G (Sep 21, 2011)

Phenergan as first line? Guess it depends on area your in. Phenergan has been removed from EMS services and replaced with Zofran. Even in hospital its mainly Zofran given its good safety profile and effectiveness. 

Phenergan has potential to cause some major issues and has resulted in serious injury to patients when not diluted properly and when extravasation occurs. Quite a few high profile cases resulted from Phenergan use with some people losing fingers.


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## 8jimi8 (Sep 21, 2011)

18G said:


> Phenergan as first line? Guess it depends on area your in. Phenergan has been removed from EMS services and replaced with Zofran. Even in hospital its mainly Zofran given its good safety profile and effectiveness.
> 
> Phenergan has potential to cause some major issues and has resulted in serious injury to patients when not diluted properly and when extravasation occurs. Quite a few high profile cases resulted from Phenergan use with some people losing fingers.



I think phenergan reactions are just as rare.  Knowing your medication profile can guide Your clinical judgement.  The order specifically reads 4mg ondansetron IV q4•  for n/v refractory to phenergan


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## 18G (Sep 21, 2011)

I dont doubt ya. Around here though Phenergan isnt usually the first antiemetic of choice. In PA we only have Zofran which replaced Phenergan when it was pulled for safety concerns. And in WV we have Zofran and Compazine.


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## 8jimi8 (Sep 21, 2011)

q6 rather


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## jwk (Sep 21, 2011)

Katy said:


> I think from most people I know, they tend to use Phenergan as well.



Phenergan should be banned.  The risks of it's use FAR outweigh the benefits.  The risks of Zofran, FDA warning aside, are incredibly minuscule, particularly compared to phenergan.  I use (and will continue to use) Zofran on virtually every general anesthetic patient I do every day.


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## jwk (Sep 21, 2011)

8jimi8 said:


> I think phenergan reactions are just as rare.  Knowing your medication profile can guide Your clinical judgement.  The order specifically reads 4mg ondansetron IV q4•  for n/v refractory to phenergan


Uh, you're incorrect.  Bad problems from phenergan are quite common and well documented.


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## 18G (Sep 21, 2011)

jwk said:


> Uh, you're incorrect.  Bad problems from phenergan are quite common and well documented.



Agree on the Phenergan = bad. I've read A LOT of case reports of bad things happening to patients who received Phenergan. 

I believe there was (or is still) a push by an advocacy group to have hospitals not administer Phenergan or reserve its use to very select cases and have a specific policy in place for dilution and administration.


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## 8jimi8 (Sep 21, 2011)

jwk said:


> Uh, you're incorrect.  Bad problems from phenergan are quite common and well documented.



In my experience, i have witnessed ZERO adverse phenergan reactions.


Same with zofran.  Are these negative reactions centered around exstravasation?  Proper assessment of invasive lines can guide your judgement here.   I've given phenergan as a first line anti-emetic for over 4 years. That's pretty rare in my opinion


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## 8jimi8 (Sep 22, 2011)

jwk said:


> Uh, you're incorrect.  Bad problems from phenergan are quite common and well documented.



In my experience, i have witnessed ZERO adverse phenergan reactions.


Same with zofran.  Are these negative reactions centered around exstravasation?  Proper assessment of invasive lines can guide your judgement here.   I've given phenergan as a first line anti-emetic for over 4 years. That's pretty rare in my opinion.

Have You ever seen a reaction?


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