FDA - Xolair Safety Review study EXCELS

[Guest guest]

> FDA is evaluating interim safety findings from an ongoing study of Xolair

(omalizumab) that

> suggests an increased number of cardiovascular and cerebrovascular adverse

events in a

> group of patients using Xolair compared to a group of patients not given the

drug (control group).

Is there already some more information about this study?

(I have read the FDA informtion, and searched Medscape)

I am now for nearly 3 years on Xolair. And it helped me in an enormous way.

After more than 12 years on prednison, I was able to stop continous

usage 1,5 year ago.

But there are also the side effects... And right now I have nasty

heart problems.

These heart problems can also be the result of other astma meds.

But the heart problems started after i started with Xolair.

And I use the other meds (seretide, ventolin, singulair, xyzal)

already for a much longer time.

The cardiologist I am seeing now for my heart problems doesn;t know

anything about Xolair.

She only refers to a medical book dated 2007..

So, I am looking for more serious information about Xolair versus

heart issues thast I can show her.

grtz, Marjet

[Guest guest]

May I ask the dosage of Xolair that you are on?

-----Original Message-----

From: Jet <m.vloedbeld@...>

Sent: Sun, Aug 30, 2009 8:25 am

Subject: [ ] FDA - Xolair Safety Review study EXCELS

--- In , " danielpercy " <groups@...>

wrote:

> FDA is evaluating interim safety findings from an ongoing study of

Xolair (omalizumab) that

> suggests an increased number of cardiovascular and cerebrovascular

adverse events in a

> group of patients using Xolair compared to a group of patients not

given the drug (control group).

Is there already some more information about this study?

(I have read the FDA informtion, and searched Medscape)

I am now for nearly 3 years on Xolair. And it helped me in an enormous

way.

After more than 12 years on prednison, I was able to stop continous

usage 1,5 year ago.

But there are also the side effects... And right now I have nasty

heart problems.

These heart problems can also be the result of other astma meds.

But the heart problems started after i started with Xolair.

And I use the other meds (seretide, ventolin, singulair, xyzal)

already for a much longer time.

The cardiologist I am seeing now for my heart problems doesn;t know

anything about Xolair.

She only refers to a medical book dated 2007..

So, I am looking for more serious information about Xolair versus

heart issues thast I can show her.

grtz, Marjet

[Guest guest]

May I ask how old you are and is ther any heart problems in your family in

addition what kind of heart problems are you having? Also do you have any risk

factors for heart disease (eg: familial, high cholesterol/lipids,Hypertension,

overweight, smoking etc). I am just trying to understand why or how this study

may be skewed as I would be interested in the average age, weight, heart risks

of both placebo and control group in the study. I think right now it is simply

under investigative status and I hope we will know more in the very near future.

Unfortunately, these are the unknowns we are faced with involving new drugs.

Best of luck to you with your diagnosis.

[Guest guest]

> May I ask the dosage of Xolair that you are on?

375mg every 2weeks

grtz, Marjet

[Guest guest]

> May I ask how old you are

58

> and is there any heart problems in your family in addition

yes

> what kind of heart problems are you having?

Cardiac arrhythmia. And it shows very clear om ECG.

But it seems not always present.

The cardologist has also seen it.

As this is the first time that I had to see a cardiologist, more assessments

will follow. (I have never had heart problems before)

> Also do you have any risk factors for heart disease (eg: familial, high

cholesterol/lipids,Hypertension, overweight, smoking etc).

I have never smoked.

After years on pred my weight is higher. But no much too high. And is now, after

the pred medication stopped, gradually becomming lower.

After I started with Xolair, hypertension become more and more a problem. Bever

had hypertension before Xolair. Xolair is administerd in the hospital. And the

nurses measure always blood pressure.

My GP gave me an ACE inhibitor. That worked very well. Blood pressure is normal

now.

I do not have cholesterol or diabetes related problems.

> I am just trying to understand why or how this study may be skewed as I would

be interested in the average age, weight, heart risks of both placebo and

control group in the study.

Thnx for your interest.

> I think right now it is simply under investigative status and I hope we will

know more in the very near future. Unfortunately, these are the unknowns we are

faced with involving new drugs. Best of luck to you with your diagnosis.

I was just wondering someone on this list already had more information.

grtz, Marjet