Lynn - Remicade and the FDA

[Guest guest]

Lynn, the manufacturer nor the FDA can force you to disclose what

happened or to share your medical record - it is a voluntary reporting

system. But you may help define the safety profile for Remicade and

protect future patients by letting the FDA have the information. What

they want to do is analyze the situation and see if it is likely that

the Remicade was responsible for your pancreatitis and the complications

you suffered.

You can talk to your primary with whom you are friendly and ask if he

sees any problem with allowing access to your medical information.

The decision is yours alone.

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org

Re: [ ] RESEARCH - WHI: further analysis of venous

thrombosis risk with estrogen plus progestin

>

> Hi ,

> I got a certified letter from the makers of remicade. They told

me,

> they had to report what happened to me to the FDA. There concern is

that it

> was the remicade that caused the problem.They want my doctors

information

> plus access to my medical records. I am not sure what to do. It is

strange

> because it says this is voluntary on my part. I am wondering if I

don't

> give them permission they will force the issue. I don't like giving

up my

> medical records. My sons says to fill out the paper it can't change

what

> happened. What do you think??????

> Lynn

[Guest guest]

,

After thinking about this all day I decided to fill out the paper. Just

maybe it will help someone else not suffer the way I did. If it stops one

person from having to have a whipple than it was all worth it. To tell the

truth there is some relief for me, knowing that it was probably the remicade

that caused all the trouble. I will never know for sure but this is better

than not knowing anything at all. Thank you for all your help. You are

amazing!!!!

Lynn

wrote:

> Lynn, the manufacturer nor the FDA can force you to disclose what

> happened or to share your medical record - it is a voluntary reporting

> system. But you may help define the safety profile for Remicade and

> protect future patients by letting the FDA have the information. What

> they want to do is analyze the situation and see if it is likely that

> the Remicade was responsible for your pancreatitis and the complications

> you suffered.

>

> You can talk to your primary with whom you are friendly and ask if he

> sees any problem with allowing access to your medical information.

>

> The decision is yours alone.

>

>

>

> I'll tell you where to go!

>

> Mayo Clinic in Rochester

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

>

> s Hopkins Medicine

> http://www.hopkinsmedicine.org

>

> Re: [ ] RESEARCH - WHI: further analysis of venous

> thrombosis risk with estrogen plus progestin

>

> >

> > Hi ,

> > I got a certified letter from the makers of remicade. They told

> me,

> > they had to report what happened to me to the FDA. There concern is

> that it

> > was the remicade that caused the problem.They want my doctors

> information

> > plus access to my medical records. I am not sure what to do. It is

> strange

> > because it says this is voluntary on my part. I am wondering if I

> don't

> > give them permission they will force the issue. I don't like giving

> up my

> > medical records. My sons says to fill out the paper it can't change

> what

> > happened. What do you think??????

> > Lynn

>

>

>