Adverse Drug Reaction Reporting- U.S. and UK

scotty · 05-27-2005, 01:52 PM

With the possibility of an FDA Advisory hearing in the near future I wanted to post this for new members.
The FDA has a mechanism for adverse drug reaction reporting. These reports may have a BIG effect on future restrictions of ssri use. It is vital that the FDA continue to see the personal adverse effects of these drugs. You can submit your own report here:

http://www.fda.gov/medwatch/index.html

To any UK members you have available to you the yellow card system.This is a report that can be filled out by the patient that feels they have had an adverse reaction or that the drug is a defective one. This is a simple on line report.It is also possible to download exactly what yellow cards have been submitted concerning the drug.(paroxetine in this case).

http://www.mhra.gov.uk/home/idcplg?I...AGE&nodeId=289

I realise alot of you know this,but seroxat/paxil is the highest of all the top 20 complaints put together.Venlafaxine(effexor) is second.
(Thanks to Skidder for the UK information!)

elisa · 05-27-2005, 01:55 PM

GREAT Scotty !! We CAN DO something about it!!

Melinda · 05-27-2005, 01:57 PM

I reported my Paxil withdrawal problems to the FDA, and it was easy. I hope that every single person who enters this forum will do the same.

jhannon · 05-27-2005, 02:17 PM

Quote:

Originally Posted by scotty

With the possibility of an FDA Advisory hearing in the near future I wanted to post this for new members.
The FDA has a mechanism for adverse drug reaction reporting. These reports may have a BIG effect on future restrictions of ssri use. It is vital that the FDA continue to see the personal adverse effects of these drugs. You can submit your own report here:

http://www.fda.gov/medwatch/index.html

i submitted a report two weeks ago

Melinda · 05-27-2005, 07:20 PM

Yep, J, in fact I think you're the one who gave me the idea. Thanks! Let's hope it helps.

sheacarney · 05-30-2005, 01:00 PM

I submitted a report, five months ago.

neogbf · 05-30-2005, 03:20 PM

I've just submitted mine, damn that feels good!

Melinda · 05-31-2005, 09:40 AM

I was wondering if any of you have ever written directly to GSK's Paxil site with your comments. I did this a few days ago, even though I figure it's probably like spitting in the wind. The site claims that they'll respond, but, if they do, I know it will be slick and canned.

feelin'_wiggy · 05-31-2005, 12:32 PM

I filed on a couple of weeks ago. Made me feel empowered, if only just a little bit.

Melinda · 05-31-2005, 05:28 PM

Earlier today, I wrote, "I was wondering if any of you have ever written directly to GSK's Paxil site with your comments. I did this a few days ago, even though I figure it's probably like spitting in the wind. The site claims that they'll respond, but, if they do, I know it will be slick and canned." Below is the response I received today from GSK:

"Thank you for contacting GlaxoSmithKline regarding therapy with PAXIL CR¿ (paroxetine hydrochloride) and PAXIL® (paroxetine hydrochloride).

We appreciate the information provided about your experience with our product. This information is valuable to us and enables us to continue with our corporate mission to improve the quality of human life by enabling people to do more, feel better and live longer. We have forwarded the information you provided to the appropriate department for review and follow up."

HA HA HA HA. "...enabling people to do more, feel better and live longer."

I don't think so.

hope · 06-06-2005, 05:13 PM

I submitted mine almost two years ago.

malawler2 · 06-07-2005, 05:03 PM

Thanks Scotty - It feels good to know I'm taking a stand on paxil and making myself known.

scotty · 06-07-2005, 05:04 PM

Empowering isn't it!!

LF07506 · 06-27-2005, 05:35 PM

Just downloaded the paperwork - I am faxing it & mailing it tomorrow....

Delynbetter · 06-27-2005, 08:12 PM

Quote:

continue with our corporate mission to improve the quality of human life by enabling people to do more, feel better and live longer.

CONTINUE??? How about starting?? Sheesh!

Freedom · 07-05-2005, 02:18 AM

Hey Scotty,

Kind of late tonight, I will diffintely report tomorrow. I'm back!

Freedom · 07-07-2005, 01:45 AM

Scotty, It's done and it felt great!

wjacquelyn13 · 08-06-2005, 02:37 AM

I would love to know the incidence of the "rare" side effect of diabetes. Listed in the PDR under endocrine. I was dx 1 month after starting Paxil. Are there others? I truely thought it was a fluke until I read the PDR.
Into my first week of W/D after four years. Good advise. I'm glad I've been able to lurk.

Mrs. Mom · 08-25-2005, 03:03 PM

Hi Scotty aka Laurie,

I am completyly new to all this message board stuff and to paxil. I am having a terrrible time, I have never felt so weird or out of it. I am almost completley non functional. I am astonished to see how many other people are so adversely affected by this kind of drug. I dont think I could have comprehended it unless I was living this. It is a nightmare. Thank you for you works here. Sherry ada Mrs. Mom

Bern · 08-30-2005, 06:51 PM

Quote:

Originally Posted by wjacquelyn13

I would love to know the incidence of the "rare" side effect of diabetes. Listed in the PDR under endocrine. I was dx 1 month after starting Paxil. Are there others? I truely thought it was a fluke until I read the PDR.
Into my first week of W/D after four years. Good advise. I'm glad I've been able to lurk.

Seroquel, another medication for depression, causes diabetes. Maybe one day, Paxil will do the same for others. Who knows what else Glaxo Smith Kline has in store for us.

Bern · 09-10-2005, 06:41 AM

Quote:

Originally Posted by Bern

Seroquel, another medication for depression, causes diabetes. Maybe one day, Paxil will do the same for others. Who knows what else Glaxo Smith Kline has in store for us.

Nevermind

Scupper · 09-14-2005, 10:27 AM

Canadians can report adverse reactions through Heath Canada's MedEffect.

The link is http://www.hc-sc.gc.ca/dhp-mps/medeff/index_e.html

The .pdf reporting form can be found at http://www.hc-sc.gc.ca/dhp-mps/alt_f...-ei_form_e.pdf

Delynbetter · 10-08-2005, 12:28 PM

Received today. Bolding is mine and too bad they can't spell my name correctly more than once. Is there any reason why I should even think about letting them have access to my medical records? Initial suspicion is that this obtain information to try to blame it on me or my doc's instead of their primo drug.

Quote:

Dear Mrs. Wlocott:

Thank you for your recent inquiry regarding the experience subsequent to receiving Paxil (Paroxetine hydrochloride). Although we sincerely regret to learn of the experience, we thank you for bringing it to our attention.

In order to help assure the accuracy of our report, please review the enclosed "Adverse Event Report" form which reflects the information we have received to date. Please note any inaccuracies and provide the corrected information. Additionally, please provide any further details that have not been entered onto the form, sign the form, and return it to us in the enclosed postage-paid envelope. Any other information which you feel is relevant would also be appreciate (discharge summary, lab data, etc.).

We would also like permission to obtain additional information from the physician or other health care provider. Therefore, we would appreciate completion of the enclosed "Authorization To Contact Physician" form, providing us with the name, address, and telephone number of the physician. A postage-paid envelope is enclosed for convenience.

Again, we appreciate your cooperation in this matter as it enables us to maintain an accurate and up-to-date database for our product. Should you have any question, please feel free to write or call us at 1-888-825-5249 during our business hours, Monday through Friday, 8:30 a.m. to 5:00 p.m. Eastern Time.

Sincerely,

Global Clinical Safety and Pharmacovigilance

pjA0576818A
Enclosures

scotty · 10-08-2005, 12:31 PM

This one throws up a BIG red flag!! I never got any response to my adverse drug reaction filing. Was this a result of that filing??? If it is this is VERY interesting that "someone" has access to this. I would call the phone number and see how they answer it, then I would ask who they are.

scotty · 10-08-2005, 12:33 PM

I would also contact the FDA to find out if this is something "new" that they're endorsing.

05-27-2005, 01:52 PM	#1
scotty Administrator Join Date: Feb 2004 Location: new jersey Posts: 46,993	Adverse Drug Reaction Reporting- U.S. and UK With the possibility of an FDA Advisory hearing in the near future I wanted to post this for new members. The FDA has a mechanism for adverse drug reaction reporting. These reports may have a BIG effect on future restrictions of ssri use. It is vital that the FDA continue to see the personal adverse effects of these drugs. You can submit your own report here: http://www.fda.gov/medwatch/index.html To any UK members you have available to you the yellow card system.This is a report that can be filled out by the patient that feels they have had an adverse reaction or that the drug is a defective one. This is a simple on line report.It is also possible to download exactly what yellow cards have been submitted concerning the drug.(paroxetine in this case). http://www.mhra.gov.uk/home/idcplg?I...AGE&nodeId=289 I realise alot of you know this,but seroxat/paxil is the highest of all the top 20 complaints put together.Venlafaxine(effexor) is second. (Thanks to Skidder for the UK information!) __________________ AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK Last edited by scotty : 01-08-2006 at 06:41 PM.

05-27-2005, 01:55 PM	#2
elisa Join Date: Jul 2004 Location: Ontario, Canada Posts: 11,473	Re: Adverse Drug Reaction Reporting GREAT Scotty !! We CAN DO something about it!! __________________ On A/D's since 1995, switching due to side-effects on 30 different brands of TCA's, SSRI's, SNRI's, Antipsychotics, Benzo's & Imovane. 6 ECT's. Tapering from 225 mg Effexor XR May 17, 2004. (Equiv. to 60 mg Paxil) Last taper Effexor XR Jan 17, 2006 down to ZERO. Currently protracted withdrawal. Sept 2006: 25 mg Doxepin. March 13/09: 10 mg Desipramine

05-27-2005, 01:57 PM	#3
Melinda Join Date: Feb 2005 Posts: 132	Re: Adverse Drug Reaction Reporting I reported my Paxil withdrawal problems to the FDA, and it was easy. I hope that every single person who enters this forum will do the same. __________________ If we can't have world peace, I'll take inner peace. Off Paxil since 12/15/04--and one day I will be Paxil-free.

05-27-2005, 07:20 PM	#5
Melinda Join Date: Feb 2005 Posts: 132	Re: Adverse Drug Reaction Reporting Yep, J, in fact I think you're the one who gave me the idea. Thanks! Let's hope it helps. __________________ If we can't have world peace, I'll take inner peace. Off Paxil since 12/15/04--and one day I will be Paxil-free.

05-30-2005, 01:00 PM	#6
sheacarney Join Date: Jan 2005 Posts: 1,748	Re: Adverse Drug Reaction Reporting I submitted a report, five months ago. __________________ shea_alexander2000@hotmail.com Drug free since April 12th, 2005

05-30-2005, 03:20 PM	#7
neogbf Join Date: May 2005 Location: Ottawa, Canada Posts: 67	Re: Adverse Drug Reaction Reporting I've just submitted mine, damn that feels good!

05-31-2005, 09:40 AM	#8
Melinda Join Date: Feb 2005 Posts: 132	Re: Adverse Drug Reaction Reporting I was wondering if any of you have ever written directly to GSK's Paxil site with your comments. I did this a few days ago, even though I figure it's probably like spitting in the wind. The site claims that they'll respond, but, if they do, I know it will be slick and canned. __________________ If we can't have world peace, I'll take inner peace. Off Paxil since 12/15/04--and one day I will be Paxil-free.

05-31-2005, 12:32 PM	#9
feelin'_wiggy Join Date: May 2005 Location: New Orleans Posts: 3,293	Re: Adverse Drug Reaction Reporting I filed on a couple of weeks ago. Made me feel empowered, if only just a little bit. __________________ *Deborah* Life shrinks or expands in proportion to one's courage -- Anais Nin ...the most you can hope is to be a little less, in the end, the creature you were in the beginning and the middle. -- Samuel Beckett (The Unnamable) . 1998: Paxil prescribed during mother's battle with cancer. 07/03 thru 05/05: Poop out; 2 botched attempts at wd; bipolar dx; more drugs added 04/05: quit lithium, Adderall and Xanax 05/05: Began 3rd attempt at wd 07/22/05: Liberated! http://www.benzo.org.uk

05-31-2005, 05:28 PM	#10
Melinda Join Date: Feb 2005 Posts: 132	Re: Adverse Drug Reaction Reporting Earlier today, I wrote, "I was wondering if any of you have ever written directly to GSK's Paxil site with your comments. I did this a few days ago, even though I figure it's probably like spitting in the wind. The site claims that they'll respond, but, if they do, I know it will be slick and canned." Below is the response I received today from GSK: "Thank you for contacting GlaxoSmithKline regarding therapy with PAXIL CR¿ (paroxetine hydrochloride) and PAXIL® (paroxetine hydrochloride). We appreciate the information provided about your experience with our product. This information is valuable to us and enables us to continue with our corporate mission to improve the quality of human life by enabling people to do more, feel better and live longer. We have forwarded the information you provided to the appropriate department for review and follow up." HA HA HA HA. "...enabling people to do more, feel better and live longer." I don't think so. __________________ If we can't have world peace, I'll take inner peace. Off Paxil since 12/15/04--and one day I will be Paxil-free.

06-06-2005, 05:13 PM	#11
hope Join Date: Nov 2003 Posts: 3,188	Re: Adverse Drug Reaction Reporting I submitted mine almost two years ago. __________________ Hope. "I never cared much for flim flam doctors." (Doctor Baker, Little House on the Prairie). Put on Paxil in 1996 for Post-partum depression. After 5th withdrawal attempt, went into severe debilitating withdrawal, restarted Paxil in the ER which didn't work anymore. Taken off again quickly by a shrink, started on Lexapro. Body rejected all drugs except benzos. Currently off all drugs. I'd say I'm recovered. Yeah, I'd say so.

06-07-2005, 05:03 PM	#12
malawler2 Join Date: May 2005 Location: Tennessee moving to TX Posts: 18	Re: Adverse Drug Reaction Reporting Thanks Scotty - It feels good to know I'm taking a stand on paxil and making myself known.

06-07-2005, 05:04 PM	#13
scotty Administrator Join Date: Feb 2004 Location: new jersey Posts: 46,993	Re: Adverse Drug Reaction Reporting Empowering isn't it!! __________________ AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK

06-27-2005, 05:35 PM	#14
LF07506 Join Date: Jun 2005 Location: NJ Posts: 41	Re: Adverse Drug Reaction Reporting Just downloaded the paperwork - I am faxing it & mailing it tomorrow....

07-05-2005, 02:18 AM	#16
Freedom Join Date: Jun 2005 Location: Huntington Beach, CA Posts: 272	Re: Adverse Drug Reaction Reporting Hey Scotty, Kind of late tonight, I will diffintely report tomorrow. I'm back!

07-07-2005, 01:45 AM	#17
Freedom Join Date: Jun 2005 Location: Huntington Beach, CA Posts: 272	Re: Adverse Drug Reaction Reporting Scotty, It's done and it felt great!

08-06-2005, 02:37 AM	#18
wjacquelyn13 Join Date: Aug 2005 Location: Texas Posts: 1	Re: Adverse Drug Reaction Reporting I would love to know the incidence of the "rare" side effect of diabetes. Listed in the PDR under endocrine. I was dx 1 month after starting Paxil. Are there others? I truely thought it was a fluke until I read the PDR. Into my first week of W/D after four years. Good advise. I'm glad I've been able to lurk. __________________ http://justadiabetic.blogspot.com/ Just A Diabetic

08-25-2005, 03:03 PM	#19
Mrs. Mom Join Date: Aug 2005 Posts: 21	Re: Adverse Drug Reaction Reporting Hi Scotty aka Laurie, I am completyly new to all this message board stuff and to paxil. I am having a terrrible time, I have never felt so weird or out of it. I am almost completley non functional. I am astonished to see how many other people are so adversely affected by this kind of drug. I dont think I could have comprehended it unless I was living this. It is a nightmare. Thank you for you works here. Sherry ada Mrs. Mom

09-14-2005, 10:27 AM	#22
Scupper Join Date: May 2005 Location: Mount Forest, Canada Posts: 22	Re: Adverse Drug Reaction Reporting Canadians can report adverse reactions through Heath Canada's MedEffect. The link is http://www.hc-sc.gc.ca/dhp-mps/medeff/index_e.html The .pdf reporting form can be found at http://www.hc-sc.gc.ca/dhp-mps/alt_f...-ei_form_e.pdf

10-08-2005, 12:31 PM	#24
scotty Administrator Join Date: Feb 2004 Location: new jersey Posts: 46,993	Re: Adverse Drug Reaction Reporting This one throws up a BIG red flag!! I never got any response to my adverse drug reaction filing. Was this a result of that filing??? If it is this is VERY interesting that "someone" has access to this. I would call the phone number and see how they answer it, then I would ask who they are. __________________ AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK

10-08-2005, 12:33 PM	#25
scotty Administrator Join Date: Feb 2004 Location: new jersey Posts: 46,993	Re: Adverse Drug Reaction Reporting I would also contact the FDA to find out if this is something "new" that they're endorsing. __________________ AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK

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