Adverse Reactions Prozac 13/09/1991 Utah Woman Has Liver Damage: Other Side Effects Summary:


http://www.fda.gov/OHRMS/DOCKETS/AC/prozac/2443T1.PDF

DR. CASEY: Thank you. Shirley Jarrott?

MS. TRACY: Hello. I am speaking for Shirley

Jarrott. She had an emergency in her family and could not

make it from Oregon. My name is Ann Tracy from Salt Lake

City, Utah.

DR. CASEY: Excuse me, please. Mr. Bernstein, do we

have any record of the representation?


MR. BERNSTEIN: No, we do not.

DR. CASEY: Ma?am, do you know if Miss Jarrott

contacted the agency?

MS. TRACY: As far as I know, she completed

all the forms that she faxed to the agency.

Dr. Casey: Could you submit that to the agency

after your presentation?

MS. TRACY : Certainly.

I?m the Utah Director for the Prozac Survivors

Support Group and have been in constant contact with Shirley

and know of her case and the problems that she has had and, I am

representing her, I that she has had in

directly related to

would like to discuss the severe problems

her health in the use of Prozac which was

severe liver damage.

The suicidal tendencies, of course, were there as

well, but her concern is the damage to her liver that she has

to live with constantly. This is something that I have been

extremely concerned with. I?m alarmed at the high incidence

of liver impairment that seems to be being reported to you,

and the biggest reason I am concerned

directly what regulates the amount of

is because that is

Prozac within the body.

If we have the Prozac rising to higher levels, of course,

we?re going to have some very severe problems, and I think

that that might be one reason why we're seeing what we're

seeing.

Prozac has directly affected my life. I was engaged

last year to a young man who was on Prozac. He was put on

Prozac in early 1989, prescribed for stress and some

depression related to business failure. The personality
changes came quickly. I couldn?t even begin to describe the

horror that happened to him for the next two-and-a-half years

of his life.

He looks back now, after being off three months --

he would have come, but he?s too sick -- after three months of

being off, he looks back at the last two-and-a-half years and

cannot remember much. He doesn?t know what was dream and what

was real. There's no detection there of reality.

I would like to encourage your committee to start

looking at brain-wave patterns in the use of antidepressants.

When you look at brain-wave patterns of somebody on Prozac I

see a total anesthetic sleep state with eyes open. That, to

me, is frightening. I think that is why so many families are

describing their loved ones as being gone, just completely

gone. They?re no longer there. There?s really no other way

. to describe someone that you?ve loved so much who's changed so
 much.
I believe that this is also one reason why the

patients are unaware of what is happening to them and unaware

of the effects, and that is why families tend to be the ones

that notice the effects rather than the patients themselves.

Prozac works on the mood center of the brain to

remove depression, but in doing so I believe that it also

removes other feelings that are extremely vital to life. So

  many people are saying that they cannot feel guilt, they have

no conscience, they cannot love
, they cannot feel empathy or

compassion. To me, that?s alarming. To have individuals

walking around that cannot feel guilt? Of course, we would

have more violent behavior.

Another thing that really alarms me in what I have

seen with so many patients -- and Utah has got some very

severe problems with this particular drug, it?s very widely

used -- is the fact that so many people that tend to have a

tendency toward alcoholism are reverting to alcoholism with

the use of Prozac. I would like that investigated. I would

like to know why people who have worked for years to overcome

this particular addiction in their lives are reverting to

this. Dr. Teicher noted that in one of his cases. To me,

that is really frightening.

I would like you please to take another look at

Prozac. Consider all the shattered lives and shattered


families that are out there and, believe me, they are

everywhere. All you have to do is start asking. Thank you.