Cardioversion, Blood Thinners and a new medicine Exanta

[Guest guest]

Panel rejects AstraZeneca stroke drug

FDA advisory group cites liver injury in clinical trials

By Gilcrest, CBS MarketWatch

Last Update: 7:26 PM ET Sept. 10, 2004

WASHINGTON (CBS.MW) - An advisory panel to the Food and Drug Administration

late Friday declined to endorse AstraZeneca's anti-stroke drug, Exanta.

Panel members said that Exanta's risks appeared to outweigh its benefits,

citing evidence of severe liver injury to patients in clinical trials.

The panel recommended further studies of the drug for both short-term and

long-term use. Some panel members also thought that AstraZeneca (AZN: news,

chart, profile) needs to make a showing of Exanta's superiority over warfarin,

the

standard blood-thinning therapy marketed in the United States by Bristol-Myers

Squibb (BMY: news, chart, profile) under the name Coumadin.

The FDA is not bound to follow its advisory panel's advice, but does so in mo

st cases.

News of the panel's decision further drove down the British drug firm's

shares, which closed down 5.6 percent Thursday after the FDA posted its safety

concerns about Exanta on its Web site.

Shares of AstraZeneca, which ended Friday's regular session down 1.5 percent

at $43.74, fell to $42.24 in after-hours trade.

If AstraZenca can produce more convincing data on its drug's safety, Exanta

could prove a market boon for the company.

Exanta has been touted as a novel " one-dose-fits-all " improvement over

warfarin, with competitors' drugs still years behind in development, according

to

Moskowitz, market analyst with Friedman, Billings, Ramsey & Co.

AstraZeneca is seeking FDA approval of Exanta for a number of uses, including

the prevention of stroke in patients with atrial fibrillation and the

prevention of a condition known as venous thromboembolism in patients undergoing

knee-replacement surgery.

However, at Friday's meeting panel members were troubled by Exanta's rate of

severe liver injury, which in clinical studies appeared to occur in about one

in 2,000 patients.

Safety concerns about Exanta also stemmed from study data showing a two-fold

higher incidence of major bleeding from short-term use of the drug, as well as

a three-fold higher incidence of myocardial infarction, compared with

standard therapies.

However, AstraZeneca representatives tried to assure the panel that Exanta

could be used safely with monthly physician monitoring.

An AstraZeneca official told the panel that the company plans to advise

physicians in the drug's labeling that they should monitor Exanta patients for

elevations of a liver enzyme known as ALT.

AstraZeneca will soon meet with the FDA to discuss a risk-minimization plan,

the official added.

But FDA officials say that the company's plan as it's now written does not

provide assurance that it can protect patients on Exanta from life-threatening

injury.

Nonetheless, Halperin, a physician at New York-based Sinai Hospital

and an AstraZeneca consultant, called Exanta an " appealing alternative " to the

" dose adjustments and diet restrictions that are a never-ending part of life "

with the therapy warfarin.

[Guest guest]

I recently developed Afib and was initially put on Plavix by my

General Practioner. Yesterday, I consulted with a cardiologist at the

University of Iowa and she wants me to stop the Plavix and go on

Coumadin instead for a month. After the month she plans to do a

cardioversion using the controlled shock.

I must admit that I am a bit apprehensive, especially after reading

all of the problems with Coumadin and the interactions with other

drugs. After doing some research this morning on the internet, I

discovered that there is a new blood thinner on the horizon called

" Exanta " (brand name), although it is not available in the US,

Canada, or Mexico. Since this forum seems to be worldwide in scope

does anyone know where I could go to be treated with this drug. What

countries is it presently available in? Any information is

appreciated.

I asked the cardiologist if there was a drug related avenue of

Cardioversion but she informed me that the all of the drugs had more

of a chance for side effects that the electrical shock method. I

would like to hear from others who know about this subject, so that I

can make some informed choices.

[Guest guest]

I can tell you when I was first diagnosed with Afib I was put on

coumadin for about two months and then cardioverted. I was OK for

about three months and my Doc took me off the coumadin and within a

month I had another attack and was put back on coumadin and

cardioverted again . I have been on coumadin since and have had

another cardioversion.

I have not really had any problems with the drug except a little

light headed now and then.

I just had another afib episode yesterday and waited it out and

flipped back to NSR on my own.

So I beleive what others have said that cardioversion is not the

answer.

Pete Upstate NY

> I recently developed Afib and was initially put on Plavix by my

> General Practioner. Yesterday, I consulted with a cardiologist at

the

> University of Iowa and she wants me to stop the Plavix and go on

> Coumadin instead for a month. After the month she plans to do a

> cardioversion using the controlled shock.

>

> I must admit that I am a bit apprehensive, especially after reading

> all of the problems with Coumadin and the interactions with other

> drugs. After doing some research this morning on the internet, I

> discovered that there is a new blood thinner on the horizon called

> " Exanta " (brand name), although it is not available in the US,

> Canada, or Mexico. Since this forum seems to be worldwide in scope

> does anyone know where I could go to be treated with this drug.

What

> countries is it presently available in? Any information is

> appreciated.

>

> I asked the cardiologist if there was a drug related avenue of

> Cardioversion but she informed me that the all of the drugs had more

> of a chance for side effects that the electrical shock method. I

> would like to hear from others who know about this subject, so that

I

> can make some informed choices.

[Guest guest]

I'm not certain where Exanta is presently available, but probably in Europe

somewhere. As for Coumadin, I know it is daunting at first to consider it,

but those of us who have been on it for some time have pretty much learned

to live with the precautions that must be taken. At first I thought I would

bleed to dealth if I sustained even a slight injury, but that certainly is

not the case as on this list has demonstrated to all of us. In my

particular situation I am grateful for something to minimize the chance of

stroke, which, if serious, is about the worst thing I can think of. Exanta

has not been approved in the US because of the possibility of serious liver

damage, which is also something I don't want!

Good luck!

Brenta

Cardioversion, Blood Thinners and a new medicine

" Exanta "

>

> I must admit that I am a bit apprehensive, especially after reading

> all of the problems with Coumadin and the interactions with other

> drugs. After doing some research this morning on the internet, I

> discovered that there is a new blood thinner on the horizon called

> " Exanta " (brand name), although it is not available in the US,

> Canada, or Mexico. Since this forum seems to be worldwide in scope

> does anyone know where I could go to be treated with this drug. What

> countries is it presently available in? Any information is

> appreciated.

>

..

>

>

>

>

>

> Web Page - http://www.afibsupport.com

> List owner: AFIBsupport-owner

> For help on how to use the group, including how to drive it via email,

> send a blank email to AFIBsupport-help

>

> Nothing in this message should be considered as medical advice, or should

> be acted upon without consultation with one's physician.

>

[Guest guest]

Hi, SwaneeA,

Welcome to the group.

As far as I know, the only problem with Coumadin is that it might

cause bleeding, so taking it is a balance of risks. It seems to be

standard in a situation like you are currently in to prescribe it, at

least until after you have been in sinus for some time. An

alternative is to do an (hope I am describing this correctly)

ultrasound of the atria to determine if any clots are present, and if

they aren't, the doc can do a cardioversion right away.

Can someone chime in as to whether there is any problem (other than

presumably cost) do going the ultrasound route? I would think it

would be preferable to get back into sinus sooner rather than later.

I believe that after a lot of advance good publicity Exanta recently

failed its tests for U.S. approval.

I know some people are taking Plavix, but I am not that familiar with

it. I think it works differently from Coumadin.

Cardioversions often do not have a lasting effect. What meds does

your doc have you on for the afib itself? What is her plan for trying

to keep you in a normal heart rhythm after the cardioversion?

There is reliable general afib info at the afib foundation web site at

www.affacts.org