Adverse Drug Reaction Reporting- U.S. and UK - Page 2

Delynbetter · 10-08-2005, 12:41 PM

It's on Glaxo letterhead.

elisa · 10-08-2005, 01:33 PM

Quote:

Originally Posted by notdelynwell

It's on Glaxo letterhead.

Did you send the report to the FDA??? Why is the response on a GSK letterhead?? *shocked* Wouldn't that be a breach of privacy/confidentiality if the FDA handed over your complaint to GSK?????

scotty · 10-08-2005, 01:48 PM

THATS a HUGE breech of confidentiality! Let me go look at the reporting tool and see if there's a disclaimer there.

scotty · 10-08-2005, 01:51 PM

Delyn, from what I see there is NO disclaimer. Go here:
http://www.fda.gov/cder/comment/commentdrug.htm

and report this! I'm going to contact a lawyer that I have and see what he thinks.

Delynbetter · 10-08-2005, 01:56 PM

That's why I'm so confused. I don't remember filing anything directly with Glaxo and I can't find anything on their website where I could have even if I had wanted.

Some of the sections are filled in, although it be incorrectly in my opinion...

Action taken with Paxil: Was the suspect drug withdrawn? (Yes is checked)
If withdrawn, did the symptoms: (unknown is checked)
Was the suspect drug reintroduced? (unknown checked)

Since the "withdrawal of Paxil" was the cause of adverse event, this is going to be very difficult to fill out.

On the Authorization to Contact Physician form and bolding is theirs:

Quote:

If you have consulted a physician (or other licensed medical practitioner) regarding this event, we would like to contact him/her for further details. Information from your physician (or other licensed medical practitioner) will support GlaxoSmithKline's worldwide efforts to monitor and evaluate the effects of our marketed products and to make reports, as may be required under law, to FDA or other regulatory authorities. Customarily patients are not identified by name in such reports. We will keep your identity confidential unless legally required to do otherwise. Please sign below to grant permission for us ot contact your physician (or other licensed medical practitioner) for further information regarding this event.

Yeah, contact that physician so that you can get back up for all the lies you told the physician. The physician never knew this crap was going to happen, doesn't understand what is happening, but you are going to use the information you gave them to help me. Uh-huh. Let's see what else we can find in my chart that you can use against me possibly. Or let's go for the doctor because they prescribed it for anxiety and your information says antidepressant, even though every last one of your reps were touting this as the new miracle anxiety drug.

What a crock, in my opinion. If anyone else sees a good side to releasing anything personal to Glaxo, please let me in on it. It feels more like giving a convicted robber a key to the house with the security alarm code attached.

scotty · 10-08-2005, 04:56 PM

Yea, contact the doctor.. that will do alot since they tow the GSK line when it comes to paxil. Nice little package GSK has going. If your doctor, who was informed by GSK, doesn't agree with withdrawal then it doesn't exist. Bunch of c*ap!

eileen · 10-26-2005, 08:12 AM

WoW that is bad! they are a lot of parasites feeding off us to get rich.while reading through this, I'm reminded that they sent a forum to be filled to my X-Psychiatrist and he was going to send it in without my permission. That was before I knew that he was their RUBBER DUCKIE.
eileen

smhfly · 10-26-2005, 03:52 PM

My own family and friends dont believe me , and these are the people that love me. Does anyone really think it will do any good. sue

scotty · 10-26-2005, 03:54 PM

Yes, it will do good. Someday in the not so distant future the truth about these drugs is going to be made public. Then those adverse drug reaction reports are going to be the proof that this has been going on for years and ignored.

smhfly · 10-26-2005, 04:00 PM

I suppose for us that are still suffering it will do no good, but maybe it will help others in the future if i could spare one person this horrendous w/d it will be worth it.

scotty · 10-26-2005, 04:05 PM

Exactly!! That's why I do what I do. I can't change what happened to Ryan, but I'll be darned if I'll let it continue to hurt others.

smhfly · 10-26-2005, 04:07 PM

I still cant help but be sad for the rest of us who werent so lucky as to be warned.

scotty · 10-26-2005, 07:44 PM

Oh, I agree wholeheartedly, but that can't be changed now. Part of reconciling this whole experience is taking the information that survivors of paxil have not put together and doing something with it to change things.

eileen · 10-26-2005, 08:38 PM

I think it is good to keep on reporting. If they get enough reports, then they will have to believe it. Is there any way I can find out if my doctor was doling out the Paxil in his studies. I would like to prove that and then report what he did. IT'S TIME WE STOOD UP AND STOPPED THIS HORRIBLE ABUSE OF OUR LIVES. When it is children, I think they should have to go to jail.

eileen

ducktail · 01-14-2006, 08:37 AM

What about us Aussies?? What can we do???

Feelin' lonely down here!!

Kelli Duck

rdjanis · 01-14-2006, 08:50 AM

I can't believe I have missed this thread!!! This is nuts!! Did you ever contact the lawyer about it Laurie??

eileen · 01-14-2006, 11:20 AM

Hi Keli, in Canada we report to Health Canada and in the USA they report to The FDA that is the federal drug ? association I think? somebody will inform us from the States soon. You will have somewhere in Australia to report this. Do a search on google and you'll find it. Good Luck with your search.

eileen

rdjanis · 01-14-2006, 11:57 AM

Here you go ductail:

https://www.tgasime.health.gov.au/SI...f?OpenDatabase

eileen · 01-14-2006, 02:01 PM

You can find out anything in here.

eileen

gruvingal · 02-04-2006, 10:01 AM

Did not know this. Of course it's not like it's probably advertised anywhere. I am going to do this as soon as I get off of here!

Ginger · 04-03-2006, 05:03 PM

I am blown away by the comments. I don't want to give up and I keep trying to find reasons to believe it is getting better. I quit paxil March 24 or 25, no weaning down, 40 mg. By the middle of last week I knew I was sick from not taking paxil. I didn't know this was going to happen. I will report to FDA

LossLeader · 04-03-2006, 05:37 PM

Ginger, if it gets too bad in the next week or so, it's not too late to go back on and wean down slowly, which would lessen the withdrawal. That wouldn't be giving up, it just might be making it easier on yourself.

Ginger · 04-03-2006, 06:00 PM

LossLeader, thanks. I just want to cry. Discovering I am not alone helps. The withdrawal has made it hard to work or function much away from home.

Ginger · 04-06-2006, 09:15 AM

I reported.

scotty · 04-06-2006, 09:18 AM

Great Ginger! this is the only method of documenting our experiences to the FDA. At some point they have to take the data into consideration.

10-08-2005, 12:41 PM	#26
Delynbetter Join Date: May 2005 Location: Texas Posts: 10,769	Re: Adverse Drug Reaction Reporting It's on Glaxo letterhead.

10-08-2005, 01:48 PM	#28
scotty Administrator Join Date: Feb 2004 Location: new jersey Posts: 46,950	Re: Adverse Drug Reaction Reporting THATS a HUGE breech of confidentiality! Let me go look at the reporting tool and see if there's a disclaimer there. __________________ AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK

10-08-2005, 01:51 PM	#29
scotty Administrator Join Date: Feb 2004 Location: new jersey Posts: 46,950	Re: Adverse Drug Reaction Reporting Delyn, from what I see there is NO disclaimer. Go here: http://www.fda.gov/cder/comment/commentdrug.htm and report this! I'm going to contact a lawyer that I have and see what he thinks. __________________ AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK

10-08-2005, 04:56 PM	#31
scotty Administrator Join Date: Feb 2004 Location: new jersey Posts: 46,950	Re: Adverse Drug Reaction Reporting Yea, contact the doctor.. that will do alot since they tow the GSK line when it comes to paxil. Nice little package GSK has going. If your doctor, who was informed by GSK, doesn't agree with withdrawal then it doesn't exist. Bunch of c*ap! __________________ AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK

10-26-2005, 08:12 AM	#32
eileen Join Date: Sep 2005 Location: Canada Posts: 10,523	Re: Adverse Drug Reaction Reporting WoW that is bad! they are a lot of parasites feeding off us to get rich.while reading through this, I'm reminded that they sent a forum to be filled to my X-Psychiatrist and he was going to send it in without my permission. That was before I knew that he was their RUBBER DUCKIE. eileen __________________ June 13/07-reducing by .05mg. every four weeks to present. October 29/08-Paxil Free 2006-Cut Trazodone from 150mg to 100mg. Sept 07/09- Trazodone 75mg. 4/10 Weaning Benzo. 12/11 Benzo Free! Started this journey of horror with AD's in 1994, Put on Paxil 30 mg in Feb/1995 I will survive!

10-26-2005, 03:52 PM	#33
smhfly Join Date: Feb 2005 Posts: 127	Re: Adverse Drug Reaction Reporting My own family and friends dont believe me , and these are the people that love me. Does anyone really think it will do any good. sue

10-26-2005, 03:54 PM	#34
scotty Administrator Join Date: Feb 2004 Location: new jersey Posts: 46,950	Re: Adverse Drug Reaction Reporting Yes, it will do good. Someday in the not so distant future the truth about these drugs is going to be made public. Then those adverse drug reaction reports are going to be the proof that this has been going on for years and ignored. __________________ AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK

10-26-2005, 04:00 PM	#35
smhfly Join Date: Feb 2005 Posts: 127	Re: Adverse Drug Reaction Reporting I suppose for us that are still suffering it will do no good, but maybe it will help others in the future if i could spare one person this horrendous w/d it will be worth it.

10-26-2005, 04:05 PM	#36
scotty Administrator Join Date: Feb 2004 Location: new jersey Posts: 46,950	Re: Adverse Drug Reaction Reporting Exactly!! That's why I do what I do. I can't change what happened to Ryan, but I'll be darned if I'll let it continue to hurt others. __________________ AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK

10-26-2005, 04:07 PM	#37
smhfly Join Date: Feb 2005 Posts: 127	Re: Adverse Drug Reaction Reporting I still cant help but be sad for the rest of us who werent so lucky as to be warned.

10-26-2005, 07:44 PM	#38
scotty Administrator Join Date: Feb 2004 Location: new jersey Posts: 46,950	Re: Adverse Drug Reaction Reporting Oh, I agree wholeheartedly, but that can't be changed now. Part of reconciling this whole experience is taking the information that survivors of paxil have not put together and doing something with it to change things. __________________ AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK

10-26-2005, 08:38 PM	#39
eileen Join Date: Sep 2005 Location: Canada Posts: 10,523	Re: Adverse Drug Reaction Reporting I think it is good to keep on reporting. If they get enough reports, then they will have to believe it. Is there any way I can find out if my doctor was doling out the Paxil in his studies. I would like to prove that and then report what he did. IT'S TIME WE STOOD UP AND STOPPED THIS HORRIBLE ABUSE OF OUR LIVES. When it is children, I think they should have to go to jail. eileen __________________ June 13/07-reducing by .05mg. every four weeks to present. October 29/08-Paxil Free 2006-Cut Trazodone from 150mg to 100mg. Sept 07/09- Trazodone 75mg. 4/10 Weaning Benzo. 12/11 Benzo Free! Started this journey of horror with AD's in 1994, Put on Paxil 30 mg in Feb/1995 I will survive!

01-14-2006, 08:37 AM	#40
ducktail Join Date: Dec 2005 Location: Sydney, Australia Posts: 337	Re: Adverse Drug Reaction Reporting- U.S. and UK What about us Aussies?? What can we do??? Feelin' lonely down here!! Kelli Duck __________________ Started Aropax 40mg June 1997 Aropax causes me extreme lethargy, brain fog, weight gain, emotional numbness Tapered to 35mg Jan 2006 Tapering by 2.5mg every 2-3 weeks Down to 18mg April 2006 Starting to wake up and feel again!! Tapering by .5 to 1mg at a time Down to 8mg Sept 2006 Down to 5mg late Nov 2006 Back up to 5.5mg late Dec 2006 Down to 3mg June 2007 Down to ZERO 16 September 2007 Stopped taking Murelax Jan 2006 Weight loss: 15kg since Sept 2006

01-14-2006, 08:50 AM	#41
rdjanis "has a lavender scented keyboard" Join Date: Mar 2004 Location: Ontario Posts: 22,214	Re: Adverse Drug Reaction Reporting- U.S. and UK I can't believe I have missed this thread!!! This is nuts!! Did you ever contact the lawyer about it Laurie?? __________________ Rita

01-14-2006, 11:20 AM	#42
eileen Join Date: Sep 2005 Location: Canada Posts: 10,523	Re: Adverse Drug Reaction Reporting- U.S. and UK Hi Keli, in Canada we report to Health Canada and in the USA they report to The FDA that is the federal drug ? association I think? somebody will inform us from the States soon. You will have somewhere in Australia to report this. Do a search on google and you'll find it. Good Luck with your search. eileen __________________ June 13/07-reducing by .05mg. every four weeks to present. October 29/08-Paxil Free 2006-Cut Trazodone from 150mg to 100mg. Sept 07/09- Trazodone 75mg. 4/10 Weaning Benzo. 12/11 Benzo Free! Started this journey of horror with AD's in 1994, Put on Paxil 30 mg in Feb/1995 I will survive!

01-14-2006, 11:57 AM	#43
rdjanis "has a lavender scented keyboard" Join Date: Mar 2004 Location: Ontario Posts: 22,214	Re: Adverse Drug Reaction Reporting- U.S. and UK Here you go ductail: https://www.tgasime.health.gov.au/SI...f?OpenDatabase __________________ Rita

01-14-2006, 02:01 PM	#44
eileen Join Date: Sep 2005 Location: Canada Posts: 10,523	Re: Adverse Drug Reaction Reporting- U.S. and UK You can find out anything in here. eileen __________________ June 13/07-reducing by .05mg. every four weeks to present. October 29/08-Paxil Free 2006-Cut Trazodone from 150mg to 100mg. Sept 07/09- Trazodone 75mg. 4/10 Weaning Benzo. 12/11 Benzo Free! Started this journey of horror with AD's in 1994, Put on Paxil 30 mg in Feb/1995 I will survive!

02-04-2006, 10:01 AM	#45
gruvingal Join Date: Dec 2005 Posts: 54	Re: Adverse Drug Reaction Reporting- U.S. and UK Did not know this. Of course it's not like it's probably advertised anywhere. I am going to do this as soon as I get off of here!

04-03-2006, 05:03 PM	#46
Ginger Join Date: Apr 2006 Posts: 606	Re: Adverse Drug Reaction Reporting- U.S. and UK I am blown away by the comments. I don't want to give up and I keep trying to find reasons to believe it is getting better. I quit paxil March 24 or 25, no weaning down, 40 mg. By the middle of last week I knew I was sick from not taking paxil. I didn't know this was going to happen. I will report to FDA

04-03-2006, 05:37 PM	#47
LossLeader Join Date: Feb 2006 Location: London Posts: 1,573	Re: Adverse Drug Reaction Reporting- U.S. and UK Ginger, if it gets too bad in the next week or so, it's not too late to go back on and wean down slowly, which would lessen the withdrawal. That wouldn't be giving up, it just might be making it easier on yourself. __________________ I see my light come shining, from the west down to the east Any day now, any day now, I shall be released

04-03-2006, 06:00 PM	#48
Ginger Join Date: Apr 2006 Posts: 606	Re: Adverse Drug Reaction Reporting- U.S. and UK LossLeader, thanks. I just want to cry. Discovering I am not alone helps. The withdrawal has made it hard to work or function much away from home.

04-06-2006, 09:15 AM	#49
Ginger Join Date: Apr 2006 Posts: 606	Re: Adverse Drug Reaction Reporting- U.S. and UK I reported.

04-06-2006, 09:18 AM	#50
scotty Administrator Join Date: Feb 2004 Location: new jersey Posts: 46,950	Re: Adverse Drug Reaction Reporting- U.S. and UK Great Ginger! this is the only method of documenting our experiences to the FDA. At some point they have to take the data into consideration. __________________ AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK

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