Re: INFO - TNF inhibitor use and liver toxicity

[Guest guest]

,

Am I reading this correctly? Are they saying that in all but 7 of the

cases, other medical conditions could be blamed for the liver failure?

But then I see that they only reviewed 50 of the 134 cases of liver

failure, so actually more cases could have been linked to the TNF

inhibitors. I hope this will mean that they will start monitoring

liver functions for those of us on TNF inhibitors.

a

On Apr 11, 2005, at 7:18 PM, wrote:

> Bulletin on the Rheumatic Diseases

> Volume 52, Number 8

>

>

> Hepatotoxicity. Recent FDA postmarketing surveillance unexpectedly

> revealed

> 134 spontaneous reports of liver failure associated with TNF

> inhibitor use

> (16,21). In a detailed review of 50 cases (receiving either

> infliximab or

> etanercept), confounding diagnoses or hepatoxin exposure was seen in

> 43

> cases (eg, sepsis, TB, isoniazid use, alcohol, viral hepatitis, GVHD,

> hepatotoxic drugs). However, in 7 cases no other cause could be

> identified

> suggesting that TNF inhibitor use may have lead to hepatic failure.

> In the

> clinical trials with infliximab and adalimumab, sporadic 2- to 3-fold

> liver

> function test elevations may have been attributed to the TNF

> inhibitor.

>

>

> http://www.arthritis.org/research/Bulletin/Vol52No8/Safety_Concerns.asp

>

>

>

>

> Not an MD

>

> I'll tell you where to go!

>

> Mayo Clinic in Rochester

> http://www.mayoclinic.org/rochester

>

> s Hopkins Medicine

> http://www.hopkinsmedicine.org

>

>

>

>

[Guest guest]

,

Am I reading this correctly? Are they saying that in all but 7 of the

cases, other medical conditions could be blamed for the liver failure?

But then I see that they only reviewed 50 of the 134 cases of liver

failure, so actually more cases could have been linked to the TNF

inhibitors. I hope this will mean that they will start monitoring

liver functions for those of us on TNF inhibitors.

a

On Apr 11, 2005, at 7:18 PM, wrote:

> Bulletin on the Rheumatic Diseases

> Volume 52, Number 8

>

>

> Hepatotoxicity. Recent FDA postmarketing surveillance unexpectedly

> revealed

> 134 spontaneous reports of liver failure associated with TNF

> inhibitor use

> (16,21). In a detailed review of 50 cases (receiving either

> infliximab or

> etanercept), confounding diagnoses or hepatoxin exposure was seen in

> 43

> cases (eg, sepsis, TB, isoniazid use, alcohol, viral hepatitis, GVHD,

> hepatotoxic drugs). However, in 7 cases no other cause could be

> identified

> suggesting that TNF inhibitor use may have lead to hepatic failure.

> In the

> clinical trials with infliximab and adalimumab, sporadic 2- to 3-fold

> liver

> function test elevations may have been attributed to the TNF

> inhibitor.

>

>

> http://www.arthritis.org/research/Bulletin/Vol52No8/Safety_Concerns.asp

>

>

>

>

> Not an MD

>

> I'll tell you where to go!

>

> Mayo Clinic in Rochester

> http://www.mayoclinic.org/rochester

>

> s Hopkins Medicine

> http://www.hopkinsmedicine.org

>

>

>

>

[Guest guest]

Well, this makes me greatful that my rheumatologist checks my liver

enzymes every 2 months!! No more complaints from me over that!!..Marina

[Guest guest]

Well, this makes me greatful that my rheumatologist checks my liver

enzymes every 2 months!! No more complaints from me over that!!..Marina

[Guest guest]

Yes, a, actually all of them could be linked to the TNF inhibitors, but

only 50 cases were studied in detail. Of those 50, in 7 there was no other

explanation for the liver failures (but that doesn't mean that the other 43

weren't, just that there were other conditions that could have explained

it).

That leaves 84 that they didn't closely examine.

Also, since we have an abysmal system for reporting adverse reactions, it's

estimated that only between 1 and 10 percent ever get reported. So multiply

the number of known cases by between 10 to 100 and you may have a more

accurate figure!

Not an MD

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org

Re: [ ] INFO - TNF inhibitor use and liver toxicity

,

Am I reading this correctly? Are they saying that in all but 7 of the

cases, other medical conditions could be blamed for the liver failure?

But then I see that they only reviewed 50 of the 134 cases of liver

failure, so actually more cases could have been linked to the TNF

inhibitors. I hope this will mean that they will start monitoring

liver functions for those of us on TNF inhibitors.

a

On Apr 11, 2005, at 7:18 PM, wrote:

> Bulletin on the Rheumatic Diseases

> Volume 52, Number 8

>

>

> Hepatotoxicity. Recent FDA postmarketing surveillance unexpectedly

> revealed

> 134 spontaneous reports of liver failure associated with TNF

> inhibitor use

> (16,21). In a detailed review of 50 cases (receiving either

> infliximab or

> etanercept), confounding diagnoses or hepatoxin exposure was seen in

> 43

> cases (eg, sepsis, TB, isoniazid use, alcohol, viral hepatitis, GVHD,

> hepatotoxic drugs). However, in 7 cases no other cause could be

> identified

> suggesting that TNF inhibitor use may have lead to hepatic failure.

> In the

> clinical trials with infliximab and adalimumab, sporadic 2- to 3-fold

> liver

> function test elevations may have been attributed to the TNF

> inhibitor.

>

>

> http://www.arthritis.org/research/Bulletin/Vol52No8/Safety_Concerns.asp

>

>

>

>

> Not an MD

>

> I'll tell you where to go!

>

> Mayo Clinic in Rochester

> http://www.mayoclinic.org/rochester

>

> s Hopkins Medicine

> http://www.hopkinsmedicine.org

>

[Guest guest]

Yes, a, actually all of them could be linked to the TNF inhibitors, but

only 50 cases were studied in detail. Of those 50, in 7 there was no other

explanation for the liver failures (but that doesn't mean that the other 43

weren't, just that there were other conditions that could have explained

it).

That leaves 84 that they didn't closely examine.

Also, since we have an abysmal system for reporting adverse reactions, it's

estimated that only between 1 and 10 percent ever get reported. So multiply

the number of known cases by between 10 to 100 and you may have a more

accurate figure!

Not an MD

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org

Re: [ ] INFO - TNF inhibitor use and liver toxicity

,

Am I reading this correctly? Are they saying that in all but 7 of the

cases, other medical conditions could be blamed for the liver failure?

But then I see that they only reviewed 50 of the 134 cases of liver

failure, so actually more cases could have been linked to the TNF

inhibitors. I hope this will mean that they will start monitoring

liver functions for those of us on TNF inhibitors.

a

On Apr 11, 2005, at 7:18 PM, wrote:

> Bulletin on the Rheumatic Diseases

> Volume 52, Number 8

>

>

> Hepatotoxicity. Recent FDA postmarketing surveillance unexpectedly

> revealed

> 134 spontaneous reports of liver failure associated with TNF

> inhibitor use

> (16,21). In a detailed review of 50 cases (receiving either

> infliximab or

> etanercept), confounding diagnoses or hepatoxin exposure was seen in

> 43

> cases (eg, sepsis, TB, isoniazid use, alcohol, viral hepatitis, GVHD,

> hepatotoxic drugs). However, in 7 cases no other cause could be

> identified

> suggesting that TNF inhibitor use may have lead to hepatic failure.

> In the

> clinical trials with infliximab and adalimumab, sporadic 2- to 3-fold

> liver

> function test elevations may have been attributed to the TNF

> inhibitor.

>

>

> http://www.arthritis.org/research/Bulletin/Vol52No8/Safety_Concerns.asp

>

>

>

>

> Not an MD

>

> I'll tell you where to go!

>

> Mayo Clinic in Rochester

> http://www.mayoclinic.org/rochester

>

> s Hopkins Medicine

> http://www.hopkinsmedicine.org

>

[Guest guest]

I hope this means they will add warnings to the prescribing information

and make recommendations for routine liver profile tests. My old

rheumy said it was only necessary to have blood tests for liver profile

every 6 months while on Enbrel.

My new rheumy is testing me more often, but I think it's because of the

liver scare I had.

a

On Apr 14, 2005, at 12:06 AM, wrote:

>

> Yes, a, actually all of them could be linked to the TNF

> inhibitors, but

> only 50 cases were studied in detail. Of those 50, in 7 there was no

> other

> explanation for the liver failures (but that doesn't mean that the

> other 43

> weren't, just that there were other conditions that could have

> explained

> it).

>

> That leaves 84 that they didn't closely examine.

>

> Also, since we have an abysmal system for reporting adverse reactions,

> it's

> estimated that only between 1 and 10 percent ever get reported. So

> multiply

> the number of known cases by between 10 to 100 and you may have a more

> accurate figure!

>

>

>

>

> Not an MD

[Guest guest]

I hope this means they will add warnings to the prescribing information

and make recommendations for routine liver profile tests. My old

rheumy said it was only necessary to have blood tests for liver profile

every 6 months while on Enbrel.

My new rheumy is testing me more often, but I think it's because of the

liver scare I had.

a

On Apr 14, 2005, at 12:06 AM, wrote:

>

> Yes, a, actually all of them could be linked to the TNF

> inhibitors, but

> only 50 cases were studied in detail. Of those 50, in 7 there was no

> other

> explanation for the liver failures (but that doesn't mean that the

> other 43

> weren't, just that there were other conditions that could have

> explained

> it).

>

> That leaves 84 that they didn't closely examine.

>

> Also, since we have an abysmal system for reporting adverse reactions,

> it's

> estimated that only between 1 and 10 percent ever get reported. So

> multiply

> the number of known cases by between 10 to 100 and you may have a more

> accurate figure!

>

>

>

>

> Not an MD