Glaxo Faces Lawsuits From U.S. Parents Over Paxil

[Guest guest]

In a message dated 9/7/04 3:59:10 AM US Eastern Standard Time,

israelswarrior@... writes:

> Mon, Sep 06, 2004

>

> Health – Reuters

> Glaxo Faces Lawsuits from U.S. Parents Over Paxil

>

> LONDON (Reuters) - GlaxoKline Plc is facing a number of lawsuits from

> U.S. parents of children and adolescents given its antidepressant Paxil,

> following claims the company suppressed data showing the drug increased

> suicidal tendencies in young people.

> A company spokesman confirmed on Monday that a number of suits had been

> received, adding the company intended to defend itself. GSK

Hi Dawn;

I am so happy to see this one because of all the families I talk to who have

been forced to face such a nightmare.

I had been on some of Annie Armens shows and we are doing promotional work

together and I had the opportunity to read of your life. I am so sorry for the

experience and I greatly admire the use of your life.

[Guest guest]

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=pubmed & dopt=Abstra\

ct & list_uids=11465683

1: Ann Clin Psychiatry. 2001 Mar;13(1):31-41. Related Articles, Links

Use of antidepressants in treatment of comorbid diabetes mellitus and

depression as well as in diabetic neuropathy.

Goodnick PJ.

Department of Psychiatry, University of Miami School of Medicine, Florida

33136, USA. goodnick@...

After a brief review of epidemiology, the focus is on biochemistry of

diabetes. Animal and human studies are reviewed in terms of the impact of

alterations in catecholamines and serotonin (5-hydroxytryptamine, 5HT) on

glucose utilization. Then, the implications of these experimental results

for the choice of antidepressant in comorbid diabetes mellitus and

depression as well as in diabetic neuropathy are discussed. Results of

clinical investigations are then reviewed in terms of the above hypotheses.

An Index Medicus Search for the past 10 years was supplemented by references

from previous related reviews of the topic as well as by pending results,

where available, not previously published. The range of prevalence of

depression in diabetic patients has been 8-27%, depending on study criteria

and procedures. An increase of catecholamines appears to increase glucose

while both reducing insulin release and reducing sensitivity to insulin that

is available. In contrast, increases in serotonergic function by increased

precursor, increased release, or blocked metabolism and blocked reuptake in

contrast seem to increase sensitivity to insulin and reduce plasma glucose.

There have been six studies of fluoxetine, a selective serotonin reuptake

inhibitor (SSRI), at a dose of 60 mg/day pursued up to 12 months that have

demonstrated that medication's usefulness in diabetic patients, with

reductions in weight (to 9.3 kg), in FPG (to 45 mg%), and in HbA1c (to

2.5%). In studies in comorbid diabetes mellitus and depression,

nortriptyline, a norepinephrine reuptake inhibitor that produces increased

synaptic catechols, has led to worsening of indices of glucose control.

However, fluoxetine and sertraline, both selective serotonin reuptake

inhibitors, in the same patient group, have produced results consistent with

reductions in glucose levels. In diabetic neuropathy, perhaps due to the

fact that catecholamines and serotonin may both be implicated in pain

pathways, dual-action antidepressants appear more effective at lower doses

than do specific serotonergic agents. The tricyclic antidepressants (TCA)

(66.7%) have had success in double-blind studies, particularly imipramine,

with a 81% response rate. Yet, there are positive reports concerning the

SSRIs (paroxetine, citalopram, sertraline), as well as nefazodone, that

focus on serotonin selectivity. CONCLUSIONS: In comorbid diabetes mellitus

and depression, most evidence supports the use of fluoxetine in control of

glucose handling. Other characteristics in terms dosing, drug interactions,

cognition, and sleep make sertraline an attractive alternative agent. In

diabetic neuropathy without depression, the best choices among non-TCAs may

include sertraline, citalopram, and perhaps, venlafaxine, since the TCAs

appear to increase cravings and increase FBG levels.

Publication Types:

a.. Review

b.. Review, Tutorial

PMID: 11465683 [PubMed - indexed for MEDLINE]

[Guest guest]

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=pubmed & dopt=Abstra\

ct & list_uids=11465683

1: Ann Clin Psychiatry. 2001 Mar;13(1):31-41. Related Articles, Links

Use of antidepressants in treatment of comorbid diabetes mellitus and

depression as well as in diabetic neuropathy.

Goodnick PJ.

Department of Psychiatry, University of Miami School of Medicine, Florida

33136, USA. goodnick@...

After a brief review of epidemiology, the focus is on biochemistry of

diabetes. Animal and human studies are reviewed in terms of the impact of

alterations in catecholamines and serotonin (5-hydroxytryptamine, 5HT) on

glucose utilization. Then, the implications of these experimental results

for the choice of antidepressant in comorbid diabetes mellitus and

depression as well as in diabetic neuropathy are discussed. Results of

clinical investigations are then reviewed in terms of the above hypotheses.

An Index Medicus Search for the past 10 years was supplemented by references

from previous related reviews of the topic as well as by pending results,

where available, not previously published. The range of prevalence of

depression in diabetic patients has been 8-27%, depending on study criteria

and procedures. An increase of catecholamines appears to increase glucose

while both reducing insulin release and reducing sensitivity to insulin that

is available. In contrast, increases in serotonergic function by increased

precursor, increased release, or blocked metabolism and blocked reuptake in

contrast seem to increase sensitivity to insulin and reduce plasma glucose.

There have been six studies of fluoxetine, a selective serotonin reuptake

inhibitor (SSRI), at a dose of 60 mg/day pursued up to 12 months that have

demonstrated that medication's usefulness in diabetic patients, with

reductions in weight (to 9.3 kg), in FPG (to 45 mg%), and in HbA1c (to

2.5%). In studies in comorbid diabetes mellitus and depression,

nortriptyline, a norepinephrine reuptake inhibitor that produces increased

synaptic catechols, has led to worsening of indices of glucose control.

However, fluoxetine and sertraline, both selective serotonin reuptake

inhibitors, in the same patient group, have produced results consistent with

reductions in glucose levels. In diabetic neuropathy, perhaps due to the

fact that catecholamines and serotonin may both be implicated in pain

pathways, dual-action antidepressants appear more effective at lower doses

than do specific serotonergic agents. The tricyclic antidepressants (TCA)

(66.7%) have had success in double-blind studies, particularly imipramine,

with a 81% response rate. Yet, there are positive reports concerning the

SSRIs (paroxetine, citalopram, sertraline), as well as nefazodone, that

focus on serotonin selectivity. CONCLUSIONS: In comorbid diabetes mellitus

and depression, most evidence supports the use of fluoxetine in control of

glucose handling. Other characteristics in terms dosing, drug interactions,

cognition, and sleep make sertraline an attractive alternative agent. In

diabetic neuropathy without depression, the best choices among non-TCAs may

include sertraline, citalopram, and perhaps, venlafaxine, since the TCAs

appear to increase cravings and increase FBG levels.

Publication Types:

a.. Review

b.. Review, Tutorial

PMID: 11465683 [PubMed - indexed for MEDLINE]

[Guest guest]

Glaxo Faces Lawsuits From U.S. Parents Over Paxil

LONDON (Reuters) Sept 06 - GlaxoKline Plc is facing a number of

lawsuits from U.S. parents of children and adolescents given its antidepressant

Paxil, following claims the company suppressed data showing the drug increased

suicidal tendencies in young people.

A company spokesman confirmed on Monday that a number of suits had

been received, adding the company intended to defend itself. GSK has denied

covering up clinical trials results.

At least one case is a class-action suit.

The action by families comes in the wake of a legal clash with New

York Attorney General Eliot Spitzer, who had accused GSK of withholding negative

information about Paxil.

In the event, Europe's biggest drug maker settled the Spitzer case

last month for a surprisingly small $2.5 million.

Paxil, which is sold as Seroxat in Europe, used to be GSK's biggest

selling product. But the medicine has declined in importance following the

arrival of cheap generic versions of the drug in the United States.

The pharmaceutical industry has been criticized for keeping quiet

about negative results from clinical trials, since bad publicity would make

product marketing more difficult.

In the case of Paxil, the drug was never approved for pediatric use

and was therefore only given to children on an off-label basis at the discretion

of doctors. But various trials were conducted on its use in children and

adolescents.

GSK has defended the way in which it handled findings from these

studies.

" We've made data available in various forms, as is normal practice,

via journals, presentations at scientific meetings and in letters to healthcare

professionals, " the company spokesman said.

" We also submitted all the trial data to regulatory authorities. "

GSK is also facing several lawsuits over adverse side effects and

withdrawal problems with Paxil involving adults.