Re: FDA rejects Exanta Application

[Guest guest]

> Exanta has been associated with raised liver enzymes, a possible

sign of damage to the organ, in some patients. Panel members also

overwhelmingly rejected the company's plan to manage possible liver

toxicity.

> " The risks are significant, " Deputy Director Dr. Lurie

said...................................

You wonder how in the world Amiodarone ever got on the market

[Guest guest]

P.

As with almost ALL pharmaceuticals there is a benefit/risk factor

trade off. I believe that at the time amiodarone came on the market

there was no other antiarrhythmic available that had such a high

benefit effect. Now, with hindsight, we tend to use amiodarone

mostly when other less toxic drugs will work just as well.

Cardiologists learned about the drug, started prescribing it and saw

a high rate of efficacy as it became their first choice of medication

to please those of us who wouldn't take their " (It's not a fatal

problem. Learn to live with it.) " , type of answer.

Right now Warfarin seems to be working for the vast majority of us

preventing the stroke problem associated with A fib. In other words,

we have a proven, safe alternative readily available to us. If it

were not for Warfarin I'm sure that Exanta would have been handled by

a 'fast track' approval route in the FDA. I'm just thankful that

they are finding the risk factors now before we all started using

this very promising drug.

An amusing comment: On the last visit to my cardiologist I

specifically asked about the new anticoagulant about to be put on the

market. He glanced down at my file and said, " Judging by your type

of health insurance, it will be many years before you will start

using this drug. You are in an HMO. That is going to be a very

expensive alternative for some time to come. The manufacturers are

going to want to recover their research investment as quickly as

possible. No good HMO is going to want to help that easily. " :-)

S.

>

> > Exanta has been associated with raised liver enzymes, a possible

> sign of damage to the organ, in some patients.

<snip>

> You wonder how in the world Amiodarone ever got on the market

[Guest guest]

--- In AFIBsupport , " jpindorski1 " <xeyespy@a...>

> You wonder how in the world Amiodarone ever got on the market

:

My understanding is that Amiodarone got on the market by being

approved treat ventricular fibrillation (which is fatal without

immediate medical intervention). Thus the tradeoff in side-effects

was heavily weighted to ignore potential longterm harm to ones liver.

My understading is that Amiodarone has NEVER BEEN APPROVED by the FDA

to treat atrial fib, and that doctor's who do so are prescribing

it " off label " . It is VERY effective for a-fib, but probably would

not have passed the tradeoff test.

, Charlotte NC

[Guest guest]

--- In AFIBsupport , " jpindorski1 " <xeyespy@a...>

> You wonder how in the world Amiodarone ever got on the market

:

My understanding is that Amiodarone got on the market by being

approved treat ventricular fibrillation (which is fatal without

immediate medical intervention). Thus the tradeoff in side-effects

was heavily weighted to ignore potential longterm harm to ones liver.

My understading is that Amiodarone has NEVER BEEN APPROVED by the FDA

to treat atrial fib, and that doctor's who do so are prescribing

it " off label " . It is VERY effective for a-fib, but probably would

not have passed the tradeoff test.

, Charlotte NC

[Guest guest]

--- In AFIBsupport , " jpindorski1 " <xeyespy@a...>

> You wonder how in the world Amiodarone ever got on the market

:

My understanding is that Amiodarone got on the market by being

approved treat ventricular fibrillation (which is fatal without

immediate medical intervention). Thus the tradeoff in side-effects

was heavily weighted to ignore potential longterm harm to ones liver.

My understading is that Amiodarone has NEVER BEEN APPROVED by the FDA

to treat atrial fib, and that doctor's who do so are prescribing

it " off label " . It is VERY effective for a-fib, but probably would

not have passed the tradeoff test.

, Charlotte NC