Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Monday, February 09, 2009

GSK paroxetine study

I'll be reproducing some of these over the coming weeks.

Downloadable from the GSK website

Patient 083.003.1090

Study Medication: Paroxetine
Cause of Death: Suicide (by hanging)

This 58 year old female had hypertension on entry to the study. She had been receiving metoprolol 100mg daily and amiloride plus hydrochlorothiazide from day 54.

She had suffered five or six previous episodes of depression for which she had received treatment with bi/tri/tetracyclic antidepressants and benzodiazepines. The duration of the present episode of depression was recorded as 1 to 3 months. She had received previous treatment for this episode with bi/tri/tetracyclic antidepressants, which were stopped on day 1, and benzodiazepines, which were stopped on day 4.

The patient received 20mg paroxetine from days 0 to 8. She also received temazepam 20mg, twice or three times daily, from day 0, and chloral hydrate 500mg daily from day 1.

The patient experienced a moderately decreased appetite and mild dryness of the mouth from day 2; both events were considered to be probably related to study treatment.

The patient did not have any double flagged changes in vital signs data and only baseline laboratory assessments were performed. On day 8 the patient committed suicide by hanging (preferred term: emotional lability).

The investigator considered this to be unrelated to study treatment.
CONFIDENTIAL Seroxat Article 31 - Consolidated Response Document - January 04

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Here are some paroxetine deaths and 'incidents' you won't find on GSK's website.



Fid



Hat tip: The Truthman



Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING


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