Wyeth / Efexor ...homicidal ideation side effect now on page 43

Wyeth / Efexor ...homicidal ideation side effect now on page 43

Joined: April 1st, 2004, 4:56 pm

January 24th, 2008, 10:42 am #1


 
<FONT lang=JA face=TimesNewRoman>
<P align=left>Nervous system - </FONT><FONT face=TimesNewRoman,Bold>Frequent: </FONT><FONT lang=JA face=TimesNewRoman>amnesia, confusion, depersonalization, hypesthesia, thinking

<P align=left>abnormal, trismus, vertigo; </FONT><FONT face=TimesNewRoman,Bold>Infrequent: </FONT><FONT lang=JA face=TimesNewRoman>akathisia, apathy, ataxia, circumoral paresthesia, CNS

<P align=left>stimulation, emotional lability, euphoria, hallucinations, hostility, hyperesthesia, hyperkinesia,

<P align=left>hypotonia, incoordination, libido increased, manic reaction, myoclonus, neuralgia, neuropathy,

<P align=left>psychosis, seizure, abnormal speech, stupor, suicidal ideation; </FONT><FONT face=TimesNewRoman,Bold>Rare: </FONT><FONT lang=JA face=TimesNewRoman>abnormal/changed

<P align=left>behavior, adjustment disorder, akinesia, alcohol abuse, aphasia, bradykinesia, buccoglossal

<P align=left>syndrome, cerebrovascular accident, feeling drunk, loss of consciousness, delusions, dementia,

<P align=left>dystonia, energy increased, facial paralysis, abnormal gait, Guillain-Barre Syndrome, homicidal

<P align=left>ideation, hyperchlorhydria, hypokinesia, hysteria, impulse control difficulties, motion sickness,

<P align=left>neuritis, nystagmus, paranoid reaction, paresis, psychotic depression, reflexes decreased, reflexes

<P align=left>increased, torticollis.

<P align=left>&nbsp;

<P align=left>page 43

<P align=left>&nbsp;

<P align=left>URL to complete document =

<P align=left>http://www.wyeth.com/content/ShowLabeling.asp?id=100
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Joined: January 1st, 1970, 12:00 am

January 24th, 2008, 10:56 am #2


Like moving it around so that if anyone sees any reference to it, they'll look on whatever page given and then&nbsp;think&nbsp; "it doesn't exist"?&nbsp;&nbsp;WHY ELSE would they move it?

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Joined: April 1st, 2004, 4:56 pm

January 24th, 2008, 10:57 am #3

&nbsp;
<FONT lang=JA face=TimesNewRoman>
<P align=left>Nervous system - </FONT><FONT face=TimesNewRoman,Bold>Frequent: </FONT><FONT lang=JA face=TimesNewRoman>amnesia, confusion, depersonalization, hypesthesia, thinking

<P align=left>abnormal, trismus, vertigo; </FONT><FONT face=TimesNewRoman,Bold>Infrequent: </FONT><FONT lang=JA face=TimesNewRoman>akathisia, apathy, ataxia, circumoral paresthesia, CNS

<P align=left>stimulation, emotional lability, euphoria, hallucinations, hostility, hyperesthesia, hyperkinesia,

<P align=left>hypotonia, incoordination, libido increased, manic reaction, myoclonus, neuralgia, neuropathy,

<P align=left>psychosis, seizure, abnormal speech, stupor, suicidal ideation; </FONT><FONT face=TimesNewRoman,Bold>Rare: </FONT><FONT lang=JA face=TimesNewRoman>abnormal/changed

<P align=left>behavior, adjustment disorder, akinesia, alcohol abuse, aphasia, bradykinesia, buccoglossal

<P align=left>syndrome, cerebrovascular accident, feeling drunk, loss of consciousness, delusions, dementia,

<P align=left>dystonia, energy increased, facial paralysis, abnormal gait, Guillain-Barre Syndrome, homicidal

<P align=left>ideation, hyperchlorhydria, hypokinesia, hysteria, impulse control difficulties, motion sickness,

<P align=left>neuritis, nystagmus, paranoid reaction, paresis, psychotic depression, reflexes decreased, reflexes

<P align=left>increased, torticollis.

<P align=left>&nbsp;

<P align=left>page 43

<P align=left>&nbsp;

<P align=left>URL to complete document =

<P align=left>http://www.wyeth.com/content/ShowLabeling.asp?id=100
</FONT>
<FONT lang=JA face=TimesNewRoman>
<P align=left>Hemic and lymphatic system - </FONT><FONT face=TimesNewRoman,Bold>Frequent: </FONT><FONT lang=JA face=TimesNewRoman>ecchymosis; </FONT><FONT face=TimesNewRoman,Bold>Infrequent: </FONT><FONT lang=JA face=TimesNewRoman>anemia, leukocytosis,

<P align=left>leukopenia, lymphadenopathy, thrombocythemia; </FONT><FONT face=TimesNewRoman,Bold>Rare: </FONT><FONT lang=JA face=TimesNewRoman>basophilia, bleeding time increased,

<P align=left>cyanosis, eosinophilia, lymphocytosis, multiple myeloma, purpura, thrombocytopenia.
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Joined: April 1st, 2004, 4:56 pm

January 24th, 2008, 10:58 am #4


Multiple myeloma (also known as MM, myeloma, plasma cell myeloma, or as Kahler's disease after <A title="Otto Kahler" href="http://en.wikipedia.org/wiki/Otto_Kahler">Otto Kahler</A>) is a type of <A title=Cancer href="http://en.wikipedia.org/wiki/Cancer">cancer</A> of <A title="Plasma cell" href="http://en.wikipedia.org/wiki/Plasma_cell">plasma cells</A> which are <A title="Immune system" href="http://en.wikipedia.org/wiki/Immune_system">immune system</A> cells in bone marrow that produce <A title=Antibody href="http://en.wikipedia.org/wiki/Antibody">antibodies</A>. Its <A title=Prognosis href="http://en.wikipedia.org/wiki/Prognosis">prognosis</A>, despite therapy, is generally poor, and treatment may involve <A title=Chemotherapy href="http://en.wikipedia.org/wiki/Chemothera ... therapy</A> and <A title="Stem cell transplant" href="http://en.wikipedia.org/wiki/Stem_cell_transplant">stem cell transplant</A>. It is part of the broad group of diseases called <A title="Hematological malignancy" href="http://en.wikipedia.org/wiki/Hematologi ... atological malignancies</A>.

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<A id=Signs_and_symptoms name=Signs_and_symptoms></A>

<SPAN class=editsection>[<A title="Edit section: Signs and symptoms" href="http://en.wikipedia.org/w/index.php?tit ... 1">edit</A>]</SPAN> <SPAN class=mw-headline>Signs and symptoms</SPAN>
Because many organs can be affected by myeloma, the symptoms and signs vary greatly. A <A title=Mnemonic href="http://en.wikipedia.org/wiki/Mnemonic">mnemonic</A> sometimes used to remember the common tetrad of multiple myeloma is CRAB - C = Calcium (elevated), R = Renal failure, A = Anemia, B = Bone lesions.<SUP class=reference id=_ref-IMWG_0><A title="" href="http://en.wikipedia.org/wiki/Multiple_m ... ]</A></SUP> Myeloma has many possible symptoms, and all symptoms may be due to other causes. They are presented here in decreasing order of incidence.

<DL>
<DT>Bone pain </DT></DL>
Myeloma bone pain usually involves the spine and ribs, and worsens with activity. Persistent localized pain may indicate a pathological <A title="Bone fracture" href="http://en.wikipedia.org/wiki/Bone_fracture">bone fracture</A>. Involvement of the vertebrae may lead to <A title="Spinal cord compression" href="http://en.wikipedia.org/wiki/Spinal_cor ... on">spinal cord compression</A>. Myeloma bone disease is due to proliferation of tumor cells and release of <A title="Interleukin 6" href="http://en.wikipedia.org/wiki/Interleukin_6">IL-6</A>, also known as osteoclast activating factor (OAF), which stimulates <A title=Osteoclast href="http://en.wikipedia.org/wiki/Osteoclast">osteoclasts</A> to break down bone. These bone lesions are lytic in nature and are best seen in plain radiographs, which may show "punched-out" resorptive lesions. The breakdown of bone also leads to release of <A title=Calcium href="http://en.wikipedia.org/wiki/Calcium">calcium</A> into the blood, leading to <A title=Hypercalcemia href="http://en.wikipedia.org/wiki/Hypercalce ... alcemia</A> and its associated symptoms.

<DL>
<DT>Infection </DT></DL>
The most common infections are <A title=Pneumonia href="http://en.wikipedia.org/wiki/Pneumonia">pneumonias</A> and <A title=Pyelonephritis href="http://en.wikipedia.org/wiki/Pyelonephr ... phritis</A>. Common pneumonia pathogens include <A title="Streptococcus pneumoniae" href="http://en.wikipedia.org/wiki/Streptococ ... umoniae">S pneumoniae</A>, <A title="Staphylococcus aureus" href="http://en.wikipedia.org/wiki/Staphylococcus_aureus">S aureus</A>, and <A title="Klebsiella pneumoniae" href="http://en.wikipedia.org/wiki/Klebsiella_pneumoniae">K pneumoniae</A>, while common pathogens causing pyelonephritis include <A title="Escherichia coli" href="http://en.wikipedia.org/wiki/Escherichi ... >E.coli</A> and other <A title=Gram-negative href="http://en.wikipedia.org/wiki/Gram-negat ... egative</A> organisms. The increased risk of infection is due to immune deficiency resulting from diffuse <A title=Hypogammaglobulinemia href="http://en.wikipedia.org/wiki/Hypogammag ... linemia</A>, which is due to decreased production and increased destruction of normal <A title=Antibody href="http://en.wikipedia.org/wiki/Antibody">antibodies</A>.

<DL>
<DT>Renal failure </DT></DL>
<A title="Renal failure" href="http://en.wikipedia.org/wiki/Renal_failure">Renal failure</A> may develop both <A title="Acute renal failure" href="http://en.wikipedia.org/wiki/Acute_rena ... acutely</A> and <A title="Chronic renal failure" href="http://en.wikipedia.org/wiki/Chronic_re ... nically</A>. It is commonly due to <A title=Hypercalcemia href="http://en.wikipedia.org/wiki/Hypercalce ... alcemia</A> (see above). It may also be due to tubular damage from excretion of <A title="Light chain" href="http://en.wikipedia.org/wiki/Light_chain">light chains</A>, also called <A title="Bence Jones protein" href="http://en.wikipedia.org/wiki/Bence_Jones_protein">Bence Jones proteins</A>, which can manifest as the <A title="Fanconi syndrome" href="http://en.wikipedia.org/wiki/Fanconi_syndrome">Fanconi syndrome</A> (type II <A title="Renal tubular acidosis" href="http://en.wikipedia.org/wiki/Renal_tubu ... sis">renal tubular acidosis</A>). Other causes include glomerular deposition of <A title=Amyloid href="http://en.wikipedia.org/wiki/Amyloid">amyloid</A>, <A title=Hyperuricemia href="http://en.wikipedia.org/wiki/Hyperurice ... ricemia</A>, recurrent infections (<A title=Pyelonephritis href="http://en.wikipedia.org/wiki/Pyelonephr ... phritis</A>), and local infiltration of tumor cells.

<DL>
<DT>Anemia </DT></DL>
The <A title=Anemia href="http://en.wikipedia.org/wiki/Anemia">anemia</A> found in myeloma is usually normocytic and normochromic. It results from the replacement of normal bone marrow by infiltrating tumor cells and inhibition of normal red blood cell production (<A title=Hematopoiesis href="http://en.wikipedia.org/wiki/Hematopoie ... poiesis</A>) by <A title=Cytokines href="http://en.wikipedia.org/wiki/Cytokines">cytokines</A>.

<DL>
<DT>Neurological symptoms </DT></DL>
Common problems are weakness, confusion and fatigue due to <A title=Hypercalcemia href="http://en.wikipedia.org/wiki/Hypercalce ... alcemia</A>. <A title=Headache href="http://en.wikipedia.org/wiki/Headache">Headache</A>, visual changes and <A title=Retinopathy href="http://en.wikipedia.org/wiki/Retinopath ... nopathy</A> may be the result of hyperviscosity of the blood depending on the properties of the <A title=Paraprotein href="http://en.wikipedia.org/wiki/Paraprotei ... protein</A>. Finally, there may be <A title="Radicular pain" href="http://en.wikipedia.org/wiki/Radicular_pain">radicular pain</A>, loss of bowel or bladder control (due to involvement of <A title="Spinal cord" href="http://en.wikipedia.org/wiki/Spinal_cord">spinal cord</A> leading to cord compression) or <A title="Carpal tunnel syndrome" href="http://en.wikipedia.org/wiki/Carpal_tun ... me">carpal tunnel syndrome</A> and other <A title=Neuropathies href="http://en.wikipedia.org/wiki/Neuropathi ... pathies</A> (due to infiltration of <A title="Peripheral nerves" href="http://en.wikipedia.org/wiki/Peripheral ... peripheral nerves</A> by <A title=Amyloid href="http://en.wikipedia.org/wiki/Amyloid">amyloid</A>). It may give rise to <A title=Paraplegia href="http://en.wikipedia.org/wiki/Paraplegia">paraplegia</A> in late presenting cases.

<A id=Diagnosis name=Diagnosis></A>

<SPAN class=editsection>[<A title="Edit section: Diagnosis" href="http://en.wikipedia.org/w/index.php?tit ... 2">edit</A>]</SPAN> <SPAN class=mw-headline>Diagnosis</SPAN>
<A id=Investigations name=Investigations></A>

<SPAN class=editsection>[<A title="Edit section: Investigations" href="http://en.wikipedia.org/w/index.php?tit ... 3">edit</A>]</SPAN> <SPAN class=mw-headline>Investigations</SPAN>
The presence of unexplained <A title=Anemia href="http://en.wikipedia.org/wiki/Anemia">anemia</A>, <A title=Kidney href="http://en.wikipedia.org/wiki/Kidney">kidney</A> dysfunction, a high <A title="Erythrocyte sedimentation rate" href="http://en.wikipedia.org/wiki/Erythrocyt ... rythrocyte sedimentation rate</A> (ESR) and a high serum <A title=Protein href="http://en.wikipedia.org/wiki/Protein">protein</A> (especially raised <A title=Immunoglobulin href="http://en.wikipedia.org/wiki/Immunoglob ... lobulin</A>) may prompt further testing. A <A title="Medical doctor" href="http://en.wikipedia.org/wiki/Medical_doctor">doctor</A> will request <A title="Protein electrophoresis" href="http://en.wikipedia.org/wiki/Protein_el ... s">protein electrophoresis</A> of the blood and urine, which might show the presence of a <A title=Paraprotein href="http://en.wikipedia.org/wiki/Paraprotei ... protein</A> (monoclonal protein, or M protein) band, with or without reduction of the other (normal) immunoglobulins (known as immune paresis). One type of paraprotein is the <A title="Bence Jones protein" href="http://en.wikipedia.org/wiki/Bence_Jones_protein">Bence Jones protein</A> which is a urinary paraprotein composed of free light chains (see below). Quantitative measurements of the paraprotein are necessary to establish a diagnosis and to monitor the disease. The paraprotein is an abnormal <A title=Immunoglobulin href="http://en.wikipedia.org/wiki/Immunoglob ... lobulin</A> produced by the tumor clone. Very rarely, the myeloma is nonsecretory (not producing immunoglobulins).

In theory, multiple myeloma can produce all classes of immunoglobulin, but IgG paraproteins are most common, followed by IgA and IgM. IgD and IgE myeloma are very rare. In addition, light and or heavy chains (the building blocks of antibodies) may be secreted in isolation: &#954;- or &#955;-light chains or any of the five types of heavy chains (&#945;-, &#947;-, &#948;-, &#949;- or &#956;-heavy chains).

Additional findings include: a raised <A title=Calcium href="http://en.wikipedia.org/wiki/Calcium">calcium</A> (when <A title=Osteoclasts href="http://en.wikipedia.org/wiki/Osteoclast ... oclasts</A> are breaking down bone, releasing calcium into the bloodstream), raised serum creatinine due to reduced <A title="Renal function" href="http://en.wikipedia.org/wiki/Renal_function">renal function</A>, which may be due to paraprotein deposition in the <A title=Kidney href="http://en.wikipedia.org/wiki/Kidney">kidney</A>.

<A id=Workup name=Workup></A>

<SPAN class=editsection>[<A title="Edit section: Workup" href="http://en.wikipedia.org/w/index.php?tit ... 4">edit</A>]</SPAN> <SPAN class=mw-headline>Workup</SPAN>
The workup of suspected multiple myeloma includes a <A title="Skeletal survey" href="http://en.wikipedia.org/wiki/Skeletal_survey">skeletal survey</A>. This is a series of <A title=X-ray href="http://en.wikipedia.org/wiki/X-ray">X-rays</A> of the skull, axial skeleton and proximal long bones. Myeloma activity sometimes appear as "lytic lesions" (with local disappearance of normal bone due to resorption), and on the skull X-ray as "punched-out lesions" (pepper pot skull). <A title="Magnetic resonance imaging" href="http://en.wikipedia.org/wiki/Magnetic_r ... ">Magnetic resonance imaging</A> (MRI) is more sensitive than simple X-ray in the detection of lytic lesions, and may supersede skeletal survey, especially when vertebral disease is suspected. Occasionally a <A title="CT scan" href="http://en.wikipedia.org/wiki/CT_scan">CT scan</A> is performed to measure the size of soft tissue plasmacytomas.

A <A title="Bone marrow biopsy" href="http://en.wikipedia.org/wiki/Bone_marrow_biopsy">bone marrow biopsy</A> is usually performed to estimate the percentage of bone marrow occupied by plasma cells. This percentage is used in the diagnostic criteria for myeloma. <A title=Immunohistochemistry href="http://en.wikipedia.org/wiki/Immunohist ... emistry</A> (staining particular cell types using antibodies against surface proteins) can detect plasma cells which express immunoglobulin in the cytoplasm but usually not on the surface; myeloma cells are typically <A title=CD56 href="http://en.wikipedia.org/wiki/CD56">CD56</A>, <A title=CD38 href="http://en.wikipedia.org/wiki/CD38">CD38</A>, <A title=CD138 href="http://en.wikipedia.org/wiki/CD138">CD138</A> positive and <A title=CD19 href="http://en.wikipedia.org/wiki/CD19">CD19</A> and <A title=CD45 href="http://en.wikipedia.org/wiki/CD45">CD45</A> negative.<SUP class=reference id=_ref-IMWG_1><A title="" href="http://en.wikipedia.org/wiki/Multiple_m ... ]</A></SUP> <A title=Cytogenetics href="http://en.wikipedia.org/wiki/Cytogeneti ... enetics</A> may also be performed in myeloma for prognostic purposes.

Other useful laboratory tests include quantitative measurement of <A title=IgA href="http://en.wikipedia.org/wiki/IgA">IgA</A>, <A title=IgG href="http://en.wikipedia.org/wiki/IgG">IgG</A>, <A title=IgM href="http://en.wikipedia.org/wiki/IgM">IgM</A> (<A title=Immunoglobulin href="http://en.wikipedia.org/wiki/Immunoglob ... obulins</A>) to look for immune paresis, and &#946;2-microglobulin which provides prognostic information. On peripheral blood smear the rouleaux formation of red blood cells is commonly seen.

The recent introduction of a commercial immunoassay for measurement of free light chains potentially offers an improvement in monitoring disease progression and response to treatment, particularly where the paraprotein is difficult to measure accurately by electrophoresis (for example in light chain myeloma, or where the paraprotein level is very low). Initial research also suggests that measurement of free light chains may also be used, in conjunction with other markers, for assessment of the risk of progression from <A title="Monoclonal gammopathy of undetermined significance" href="http://en.wikipedia.org/wiki/Monoclonal ... monoclonal gammopathy of undetermined significance</A> (MGUS) to multiple myeloma.<SUP class="noprint Template-Fact"><SPAN title="This claim needs references to reliable sources&nbsp;since February 2007" style="WHITE-SPACE: nowrap">[<A title="Wikipedia:Citation needed" href="http://en.wikipedia.org/wiki/Wikipedia: ... ">citation needed</A>]</SPAN></SUP>

<A id=Diagnostic_criteria name=Diagnostic_criteria></A>

<SPAN class=editsection>[<A title="Edit section: Diagnostic criteria" href="http://en.wikipedia.org/w/index.php?tit ... 5">edit</A>]</SPAN> <SPAN class=mw-headline>Diagnostic criteria</SPAN>
In <A title=2003 href="http://en.wikipedia.org/wiki/2003">2003</A>, the International Myeloma Working Group<SUP class=reference id=_ref-IMWG_2><A title="" href="http://en.wikipedia.org/wiki/Multiple_m ... ]</A></SUP> agreed on diagnostic criteria for symptomatic myeloma, asymptomatic myeloma and <A title="Monoclonal gammopathy of undetermined significance" href="http://en.wikipedia.org/wiki/Monoclonal ... e">MGUS</A> (monoclonal gammopathy of undetermined significance):
[*]Asymptomatic myeloma:
<OL>
[*]Serum paraprotein >30 g/L AND/OR
[*]Clonal plasma cells >10% on bone marrow biopsy AND
[*]NO myeloma-related organ or tissue impairment </LI>[/list]
[*]Monoclonal gammopathy of undetermined significance (MGUS):
<OL>
[*]Serum paraprotein <30 g/L AND
[*]Clonal plasma cells <10% on bone marrow biopsy AND
[*]NO myeloma-related organ or tissue impairment </LI>[/list]</LI>[/list]
Related conditions include solitary <A title=Plasmacytoma href="http://en.wikipedia.org/wiki/Plasmacyto ... acytoma</A> (a single tumor of plasma cells, typically treated with irradiation), plasma cell <A title=Dyscrasia href="http://en.wikipedia.org/wiki/Dyscrasia">dyscrasia</A> (where only the antibodies produce symptoms, e.g. AL <A title=Amyloid href="http://en.wikipedia.org/wiki/Amyloid">amyloidosis</A>), and <A title="POEMS syndrome" href="http://en.wikipedia.org/wiki/POEMS_syndrome">POEMS syndrome</A> (peripheral neuropathy, organomegaly, endocrinopathy, monoclonal plasma cell disorder, skin changes).

<A id=Staging name=Staging></A>

<SPAN class=editsection>[<A title="Edit section: Staging" href="http://en.wikipedia.org/w/index.php?tit ... 6">edit</A>]</SPAN> <SPAN class=mw-headline>Staging</SPAN>
<DL>
<DT>International Staging System </DT></DL>
The International Staging System (ISS) for myeloma was published by the International Myeloma Working Group in 2005:<SUP class=reference id=_ref-ISS_0><A title="" href="http://en.wikipedia.org/wiki/Multiple_m ... ]</A></SUP>:
<DL>
<DT>Durie-Salmon staging system </DT></DL>
First published in 1975, the Durie-Salmon staging system <SUP class=reference id=_ref-Salmon_0><A title="" href="http://en.wikipedia.org/wiki/Multiple_m ... ]</A></SUP> is still in use, but has largely been superseded by the simpler ISS:
  • stage 1: all of
    • Hb > 10g/dL
    • normal calcium
    • Skeletal survey: normal or single plasmacytoma or osteoporosis
    • Serum paraprotein level < 5 g/dL if IgG, < 3 g/dL if IgA
    • Urinary light chain excretion < 4 g/24h </LI>
  • stage 2: fulfilling the criteria of neither 1 nor 3
  • stage 3: one or more of
    • Hb < 8.5g/dL
    • high calcium > 12mg/dL
    • Skeletal survey: 3 or more lytic bone lesions
    • Serum paraprotein >7g/dL if IgG, > 5 g/dL if IgA
    • Urinary light chain excretion > 12g/24h </LI>
    </LI>
Stages 1, 2 and 3 of the Durie-Salmon staging system can be divided into A or B depending on serum creatinine:
  • A: serum creatinine < 2mg/dL (< 177 umol/L)
  • B: serum creatinine > 2mg/dL (> 177 umol/L) </LI>
<A id=Pathophysiology name=Pathophysiology></A>

<SPAN class=editsection>[<A title="Edit section: Pathophysiology" href="http://en.wikipedia.org/w/index.php?tit ... 7">edit</A>]</SPAN> <SPAN class=mw-headline>Pathophysiology</SPAN>
Multiple myeloma develops in post-germinal center <A title="B lymphocytes" href="http://en.wikipedia.org/wiki/B_lymphocytes">B lymphocytes</A>. A <A title="Chromosomal translocation" href="http://en.wikipedia.org/wiki/Chromosoma ... hromosomal translocation</A> between the immunoglobulin <A title="Heavy chain" href="http://en.wikipedia.org/wiki/Heavy_chain">heavy chain</A> gene (on the fourteenth <A title=Chromosome href="http://en.wikipedia.org/wiki/Chromosome">chromosome</A>, locus 14q32) and an <A title=Oncogene href="http://en.wikipedia.org/wiki/Oncogene">oncogene</A> (often 11q13, 4p16.3, 6p21, 16q23 and 20q11<SUP class=reference id=_ref-Kyle_0><A title="" href="http://en.wikipedia.org/wiki/Multiple_m ... ]</A></SUP>) is frequently observed in patients with multiple myeloma. This mutation results in dysregulation of the oncogene which is thought to be an important initiating event in the pathogenesis of myeloma. The result is proliferation of a plasma cell clone and genomic instability that leads to further mutations and translocations. The chromosome 14 abnormality is observed in about 50% of all cases of myeloma. Deletion of (parts of) the thirteenth chromosome is also observed in about 50% of cases.

Production of <A title=Cytokine href="http://en.wikipedia.org/wiki/Cytokine">cytokines</A> (especially <A title="Interleukin 6" href="http://en.wikipedia.org/wiki/Interleukin_6">IL-6</A>) by the plasma cells causes much of their localised damage, such as <A title=Osteoporosis href="http://en.wikipedia.org/wiki/Osteoporos ... porosis</A>, and creates a microenvironment in which the malignant cells thrive. <A title=Angiogenesis href="http://en.wikipedia.org/wiki/Angiogenes ... genesis</A> (the attraction of new blood vessels) is increased.

The produced antibodies are deposited in various organs, leading to renal failure, polyneuropathy and various other myeloma-associated symptoms.

<A id=Treatment name=Treatment></A>

<SPAN class=editsection>[<A title="Edit section: Treatment" href="http://en.wikipedia.org/w/index.php?tit ... 8">edit</A>]</SPAN> <SPAN class=mw-headline>Treatment</SPAN>
Treatment for multiple myeloma is focused on disease containment and suppression. If the disease is completely asymptomatic (i.e. there is a paraprotein and an abnormal bone marrow population but no end-organ damage), treatment may be deferred.

In addition to direct treatment of the plasma cell proliferation, <A title=Bisphosphonate href="http://en.wikipedia.org/wiki/Bisphospho ... honates</A> (e.g. <A title=Pamidronate href="http://en.wikipedia.org/wiki/Pamidronat ... dronate</A> or <A title="Zoledronic acid" href="http://en.wikipedia.org/wiki/Zoledronic ... zoledronic acid</A>) are routinely administered to prevent fractures and <A title=Erythropoietin href="http://en.wikipedia.org/wiki/Erythropoi ... poietin</A> to treat anemia.

<A id=Initial_therapy name=Initial_therapy></A>

<SPAN class=editsection>[<A title="Edit section: Initial therapy" href="http://en.wikipedia.org/w/index.php?tit ... 9">edit</A>]</SPAN> <SPAN class=mw-headline>Initial therapy</SPAN>
Initial treatment is aimed at treating symptoms and reducing disease burden. Commonly used induction regimens include <A title=Dexamethasone href="http://en.wikipedia.org/wiki/Dexamethas ... thasone</A> with or without <A title=Thalidomide href="http://en.wikipedia.org/wiki/Thalidomid ... idomide</A> and <A title=Cyclophosphamide href="http://en.wikipedia.org/wiki/Cyclophosp ... phamide</A>, and VAD (<A title=Vincristine href="http://en.wikipedia.org/wiki/Vincristin ... ristine</A>, <A title=Doxorubicin href="http://en.wikipedia.org/wiki/Doxorubicin">adriamycin</A>, and dexamethasone). Low-dose therapy with <A title=Melphalan href="http://en.wikipedia.org/wiki/Melphalan">melphalan</A> combined with prednisone can be used to palliate symptoms in patients who cannot tolerate aggressive therapy. <A title=Plasmapheresis href="http://en.wikipedia.org/wiki/Plasmapher ... heresis</A> can be used to treat symptomatic protein proliferation (<A title="Hyperviscosity syndrome" href="http://en.wikipedia.org/wiki/Hypervisco ... rviscosity syndrome</A>).

In younger patients, therapy may include high-dose <A title=Chemotherapy href="http://en.wikipedia.org/wiki/Chemothera ... therapy</A>, <A title=Melphalan href="http://en.wikipedia.org/wiki/Melphalan">melphalan</A>, and <A title="Bone marrow transplant" href="http://en.wikipedia.org/wiki/Bone_marro ... autologous stem cell transplantation</A>. This can be given in tandem fashion, i.e. an autologous transplant followed by a second transplant. <A title="Bone marrow transplant" href="http://en.wikipedia.org/wiki/Bone_marro ... loablative (or "mini") allogeneic stem cell transplantation</A> is being investigated as an alternative to autologous stem cell transplant, or as part of a tandem transplant following an autologous transplant (also known as an "auto-mini" tandem transplant).

<A title="Hematopoietic stem cell transplantation" href="http://en.wikipedia.org/wiki/Hematopoie ... Allogeneic stem cell transplant</A> offers the possibility of a cure, but is not performed commonly. It is considered investigational given the high treatment-related mortality of 5-10% associated with the procedure.

A 2007 trial indicated that the addition of thalidomide to reduced-intensity chemotherapy (melphalan and prednisone, MP) in patients between 65-75 led to a marked prolongation (median 51 versus 33 months) in survival. Reduced intensity melphalan followed by a stem cell transplant was inferior to the MP-thalidomide regimen (median survival 38 months).<SUP class=reference id=_ref-0><A title="" href="http://en.wikipedia.org/wiki/Multiple_m ... ]</A></SUP>

<A id=Relapse name=Relapse></A>

<SPAN class=editsection>[<A title="Edit section: Relapse" href="http://en.wikipedia.org/w/index.php?tit ... 0">edit</A>]</SPAN> <SPAN class=mw-headline>Relapse</SPAN>
The natural history of myeloma is of relapse following treatment. Depending on the patient's condition, the prior treatment modalities used and the duration of remission, options for relapsed disease include re-treatment with the original agent, use of other agents (such as melphalan, cyclophosphamide, thalidomide or dexamethasone, alone or in combination), and a second autologous stem cell transplant.

Later in the course of the disease, "treatment resistance" occurs. This may be a reversible effect,<SUP class=reference id=_ref-Kyle_1><A title="" href="http://en.wikipedia.org/wiki/Multiple_m ... ]</A></SUP> and some new treatment modalities may re-sensitize the tumor to standard therapy. For patients with relapsed disease, <A title=Bortezomib href="http://en.wikipedia.org/wiki/Bortezomib">bortezomib</A> (or Velcade®) is a recent addition to the therapeutic arsenal, especially as second line therapy. Bortezomib is a <A title=Proteasome href="http://en.wikipedia.org/wiki/Proteasome">proteasome</A> inhibitor. Finally, <A title=Lenalidomide href="http://en.wikipedia.org/wiki/Lenalidomi ... idomide</A> (or Revlimid®), a less toxic thalidomide analog, is showing promise for treating myeloma.

Renal failure in multiple myeloma can be <A title="Acute renal failure" href="http://en.wikipedia.org/wiki/Acute_rena ... ">acute</A> (reversible) or <A title="Chronic renal failure" href="http://en.wikipedia.org/wiki/Chronic_re ... chronic</A> (irreversible). Acute renal failure typically resolves when the calcium and paraprotein levels are brought under control. Treatment of chronic renal failure is dependent on the type of renal failure and may involve <A title=Dialysis href="http://en.wikipedia.org/wiki/Dialysis">dialysis</A>.

<A id=Prognosis name=Prognosis></A>

<SPAN class=editsection>[<A title="Edit section: Prognosis" href="http://en.wikipedia.org/w/index.php?tit ... 1">edit</A>]</SPAN> <SPAN class=mw-headline>Prognosis</SPAN>
The <A title="" href="http://en.wikipedia.org/wiki/Multiple_m ... ernational Staging System</A> can help to predict survival, with a median survival of 62 months for stage 1 disease, 45 months for stage 2 disease, and 29 months for stage 3 disease.<SUP class=reference id=_ref-ISS_1><A title="" href="http://en.wikipedia.org/wiki/Multiple_m ... ]</A></SUP>

<A title=Cytogenetic href="http://en.wikipedia.org/wiki/Cytogeneti ... genetic</A> analysis of myeloma cells may be of <A title=Prognosis href="http://en.wikipedia.org/wiki/Prognosis">prognostic value</A>, with deletion of chromosome 13, non-hyperdiploidy and the balanced translocations t(4;14) and t(14;16) conferring a poorer prognosis. The 11q13 and 6p21 cytogenetic abnormalities are associated with a better prognosis.

Prognostic markers such as these are always generated by retrospective analyses, and it is likely that new treatment developments will improve the outlook for those with traditionally "poor-risk" disease.

<A id=Epidemiology name=Epidemiology></A>

<SPAN class=editsection>[<A title="Edit section: Epidemiology" href="http://en.wikipedia.org/w/index.php?tit ... 2">edit</A>]</SPAN> <SPAN class=mw-headline>Epidemiology</SPAN>
There are approximately 45,000 people in the <A title="United States" href="http://en.wikipedia.org/wiki/United_States">United States</A> living with multiple myeloma, and the <A title="American Cancer Society" href="http://en.wikipedia.org/wiki/American_C ... ">American Cancer Society</A> estimates that approximately 14,600 new cases of myeloma are diagnosed each year in the United States. It follows from here that the average survival at diagnosis is about three years.

Multiple myeloma is the second most prevalent blood cancer (10%) after <A title="Non-Hodgkin's lymphoma" href="http://en.wikipedia.org/wiki/Non-Hodgki ... -Hodgkin's lymphoma</A>. It represents approximately 1% of all cancers and 2% of all cancer deaths. Although the peak age of onset of multiple myeloma is 65 to 70 years of age, recent statistics indicate both increasing incidence and earlier age of onset.

Multiple myeloma affects slightly more men than women. African Americans and Native Pacific Islanders have the highest reported incidence of this disease in the United States and Asians the lowest. Results of a recent study found the incidence of myeloma to be 9.5 cases per 100,000 African Americans and 4.1 cases per 100,000 Caucasian Americans. Among African Americans, myeloma is one of the top 10 leading causes of cancer death.

<A id=See_also name=See_also></A>

<SPAN class=editsection>[<A title="Edit section: See also" href="http://en.wikipedia.org/w/index.php?tit ... 3">edit</A>]</SPAN> <SPAN class=mw-headline>See also</SPAN> <A id=References name=References></A>

<SPAN class=editsection>[<A title="Edit section: References" href="http://en.wikipedia.org/w/index.php?tit ... 4">edit</A>]</SPAN> <SPAN class=mw-headline>References</SPAN>
<OL class=references>
<LI id=_note-IMWG>^ <A title="" href="http://en.wikipedia.org/wiki/Multiple_m ... up][i][b]a[/b][/i][/sup]</A> <A title="" href="http://en.wikipedia.org/wiki/Multiple_m ... up][i][b]b[/b][/i][/sup]</A> <A title="" href="http://en.wikipedia.org/wiki/Multiple_m ... up][i][b]c[/b][/i][/sup]</A> <CITE style="FONT-STYLE: normal">International Myeloma Working Group (2003). "Criteria for the classification of monoclonal gammopathies, multiple myeloma and related disorders: a report of the International Myeloma Working Group". Br. J. Haematol. 121 (5): 749–57. <A title="Digital object identifier" href="http://en.wikipedia.org/wiki/Digital_ob ... doi</A>:<A class="external text" title=http://dx.doi.org/10.1046/j.1365-2141.2003.04355.x href="http://dx.doi.org/10.1046/j.1365-2141.2003.04355.x" rel=nofollow>10.1046/j.1365-2141.2003.04355.x</A>. <A class=external title=http://www.ncbi.nlm.nih.gov/pubmed/12780789 href="http://www.ncbi.nlm.nih.gov/pubmed/12780789">PMID 12780789</A>.</CITE>
<LI id=_note-ISS>^ <A title="" href="http://en.wikipedia.org/wiki/Multiple_m ... up][i][b]a[/b][/i][/sup]</A> <A title="" href="http://en.wikipedia.org/wiki/Multiple_m ... up][i][b]b[/b][/i][/sup]</A> <CITE style="FONT-STYLE: normal">Greipp PR, San Miguel J, Durie BG, et al (2005). "<A class="external text" title=http://jco.ascopubs.org/cgi/content/full/23/15/3412 href="http://jco.ascopubs.org/cgi/content/full/23/15/3412" rel=nofollow>International staging system for multiple myeloma</A>". J. Clin. Oncol. 23 (15): 3412–20. <A title="Digital object identifier" href="http://en.wikipedia.org/wiki/Digital_ob ... doi</A>:<A class="external text" title=http://dx.doi.org/10.1200/JCO.2005.04.242 href="http://dx.doi.org/10.1200/JCO.2005.04.242" rel=nofollow>10.1200/JCO.2005.04.242</A>. <A class=external title=http://www.ncbi.nlm.nih.gov/pubmed/15809451 href="http://www.ncbi.nlm.nih.gov/pubmed/15809451">PMID 15809451</A>.</CITE>
<LI id=_note-Salmon><A title="" href="http://en.wikipedia.org/wiki/Multiple_m ... on_0">^</A> <CITE style="FONT-STYLE: normal">Durie BG, Salmon SE (1975). "A clinical staging system for multiple myeloma. Correlation of measured myeloma cell mass with presenting clinical features, response to treatment, and survival". Cancer 36 (3): 842–54. <A class=external title=http://www.ncbi.nlm.nih.gov/pubmed/1182674 href="http://www.ncbi.nlm.nih.gov/pubmed/1182674">PMID 1182674</A>.</CITE>
<LI id=_note-Kyle>^ <A title="" href="http://en.wikipedia.org/wiki/Multiple_m ... up][i][b]a[/b][/i][/sup]</A> <A title="" href="http://en.wikipedia.org/wiki/Multiple_m ... up][i][b]b[/b][/i][/sup]</A> <CITE style="FONT-STYLE: normal">Kyle RA, Rajkumar SV (2004). "Multiple myeloma". N. Engl. J. Med. 351 (18): 1860–73. <A title="Digital object identifier" href="http://en.wikipedia.org/wiki/Digital_ob ... doi</A>:<A class="external text" title=http://dx.doi.org/10.1056/NEJMra041875 href="http://dx.doi.org/10.1056/NEJMra041875" rel=nofollow>10.1056/NEJMra041875</A>. <A class=external title=http://www.ncbi.nlm.nih.gov/pubmed/15509819 href="http://www.ncbi.nlm.nih.gov/pubmed/15509819">PMID 15509819</A>.</CITE>
<LI id=_note-0><A title="" href="http://en.wikipedia.org/wiki/Multiple_m ... ef-0">^</A> <CITE style="FONT-STYLE: normal">Facon T, Mary JY, Hulin C et al (2007). "<A class="external text" title=http://www.thelancet.com/journals/lance ... 2/abstract href="http://www.thelancet.com/journals/lance ... 2/abstract" rel=nofollow>Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99–06): a randomised trial</A>". Lancet 370: 1209-1218.</CITE> </LI>[/list]
<A id=External_links name=External_links></A>

<SPAN class=editsection>[<A title="Edit section: External links" href="http://en.wikipedia.org/w/index.php?tit ... 5">edit</A>]</SPAN> <SPAN class=mw-headline>External links</SPAN>
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Joined: April 1st, 2004, 4:56 pm

January 24th, 2008, 11:00 am #5

Like moving it around so that if anyone sees any reference to it, they'll look on whatever page given and then&nbsp;think&nbsp; "it doesn't exist"?&nbsp;&nbsp;WHY ELSE would they move it?

&nbsp;
on NATIONAL RADIO
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Joined: April 1st, 2004, 4:56 pm

January 24th, 2008, 11:02 am #6

&nbsp;
<FONT lang=JA face=TimesNewRoman>
<P align=left>Nervous system - </FONT><FONT face=TimesNewRoman,Bold>Frequent: </FONT><FONT lang=JA face=TimesNewRoman>amnesia, confusion, depersonalization, hypesthesia, thinking

<P align=left>abnormal, trismus, vertigo; </FONT><FONT face=TimesNewRoman,Bold>Infrequent: </FONT><FONT lang=JA face=TimesNewRoman>akathisia, apathy, ataxia, circumoral paresthesia, CNS

<P align=left>stimulation, emotional lability, euphoria, hallucinations, hostility, hyperesthesia, hyperkinesia,

<P align=left>hypotonia, incoordination, libido increased, manic reaction, myoclonus, neuralgia, neuropathy,

<P align=left>psychosis, seizure, abnormal speech, stupor, suicidal ideation; </FONT><FONT face=TimesNewRoman,Bold>Rare: </FONT><FONT lang=JA face=TimesNewRoman>abnormal/changed

<P align=left>behavior, adjustment disorder, akinesia, alcohol abuse, aphasia, bradykinesia, buccoglossal

<P align=left>syndrome, cerebrovascular accident, feeling drunk, loss of consciousness, delusions, dementia,

<P align=left>dystonia, energy increased, facial paralysis, abnormal gait, Guillain-Barre Syndrome, homicidal

<P align=left>ideation, hyperchlorhydria, hypokinesia, hysteria, impulse control difficulties, motion sickness,

<P align=left>neuritis, nystagmus, paranoid reaction, paresis, psychotic depression, reflexes decreased, reflexes

<P align=left>increased, torticollis.

<P align=left>&nbsp;

<P align=left>page 43

<P align=left>&nbsp;

<P align=left>URL to complete document =

<P align=left>http://www.wyeth.com/content/ShowLabeling.asp?id=100
</FONT>
MHRA (M) - Adverse Drug Reactions On-line Information Tracking (ADROIT)
<DIV class=redraft></DIV>

<DIV><A href="javascript: history.back();">Back</A>
</DIV>
<H5 style="MARGIN-BOTTOM: 1px">Asset details:</H5>
<TABLE summary="Asset details">
<TBODY>
<TR>
<TH>IARN:</TH>
<TD>DH999-000394&nbsp;</TD></TR>
<TR>
<TH>Identifier:</TH>
<TD>MHRA (M) ADROIT&nbsp;</TD></TR>
<TR>
<TH>Description:</TH>
<TD>Adverse Drug Reactions On-Line Tracking (ADROIT) of suspected adverse reactions. ADROIT is the MHRA database for storing and monitoring suspected adverse reactions to drug substances, provides a mechanism to highlight potential health threats.&nbsp;</TD></TR>
<TR>
<TH>Subject:</TH>
<TD>Adverse Drug Reactions; Information service; Medicines; Pharmaceutical services&nbsp;</TD></TR>
<TR>
<TH>Coverage:</TH>
<TD>UK&nbsp;</TD></TR>
<TR>
<TH>Date:</TH>
<TD>1993&nbsp;</TD></TR>
<TR>
<TH>Updating Frequency:</TH>
<TD>Daily&nbsp;</TD></TR>
<TR>
<TH>Date Modified:</TH>
<TD>&nbsp;</TD></TR>
<TR>
<TH>Source:</TH>
<TD>Information on ADROIT is obtained from the pharmaceutical industry and Health Professionals&nbsp;</TD></TR>
<TR>
<TH>Format:</TH>
<TD>Database&nbsp;</TD></TR>
<TR>
<TH>Language:</TH>
<TD>English&nbsp;</TD></TR>
<TR>
<TH>Author:</TH>
<TD>Medicines and Healthcare Products Regulatory Agency Market Towers 1 Nine Elms Lane London SW8 5NQ Mail to: info@mhra.gsi.gov.uk Tel: 020 7084 2000&nbsp;</TD></TR>
<TR>
<TH>Publisher:</TH>
<TD>Medicines and Healthcare Products Regulatory Agency Market Towers 1 Nine Elms Lane London SW8 5NQ Contact person: Mr Ed Scully (Executive Support) Mail to: info@mhra.gsi.gov.uk Tel: 020 7084 2000&nbsp;</TD></TR>
<TR>
<TH>Rights:</TH>
<TD>Limited. Information available by subscription to AEGIS (ADROIT Electronically Generated Information Services)&nbsp;</TD></TR>
<TR>
<TH>Category:</TH>
<TD>Health, nutrition and care/ Safety&nbsp;</TD></TR></TBODY></TABLE>
<DIV><A href="javascript: history.back();">Back</A>
</DIV>
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Joined: April 1st, 2004, 4:56 pm

January 24th, 2008, 11:04 am #7

<SPAN class=postbody><FONT color=#006699 size=2>http://www.network54.com/Forum/281849/m ... tion</FONT><FONT size=2>

MHRA admit to receiving 3 yellow cards on Venlafaxine side effect homicidal ideation
June 23 2006 at 6:23 PM morse
CONFIDENTIAL

Mr Jeremy Bryce
********* *****
***********
****** ****
Northern Ireland
*** ***

21 December 2005 MHRA Reference: LQ05/3453


Dear Mr Bryce


Thank you for your telephone call,requesting information on the side effect homicidal ideation in association with venlafaxine (Efexor).


As you may be aware the Yellow Card Scheme is the UK system for collecting and monitoring information on suspected adverse drug reactions (ADRs).The Scheme is run by the MHRA on behalf of the Commission on Human Medicines (CHM). Reports of suspected adverse drug reactions are held on a purpose-designed computer database known as the Adverse Drug Reactions On-line Information Tracking (ADROIT) database.


I have searched the ADROIT database and to date we have received a total of 3 suspected Adverse Drug Reaction reports of homicidal ideation in association with venlafaxine. This number is very small when you consider the usage of venlafaxine in the United Kingdom. It is also important to note that the inclusion of a particular reaction on the ADROIT database does not necessarily mean that it has been caused by the drug. Many factors have to be taken into account in assessing causal relationships including temporal association, the possible contribution of concomitant medication, and the underlying disease.

The current Product Information Leaflet (PIL) for venlafaxine recognises aggression as a side effect.

Further to your question regarding the differences that exist between the product information for venlafaxine in the UK compared with that in the US, with the latter recognising homicidal ideation as a suspected Adverse Drug Reaction. It is important to appreciate that it is not unusual for there to be differences in the UK and US information for medicinal products due to differences in the strengths of the medicines available and sometimes differences in the medical conditions which the products are licensed to treat.




SK LQ05/3453.doc 21/12/2005KC 1


I hope this information is helpful
Yours sincerely
Miss Shahin Kauser BSc (Hons)
Senior Pharmacovigilance Scientist
Room 15-257
Pharmacovigilance Group
Post-Licensing Division</FONT></SPAN>
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Joined: January 1st, 1970, 12:00 am

January 24th, 2008, 11:23 am #8

Like moving it around so that if anyone sees any reference to it, they'll look on whatever page given and then&nbsp;think&nbsp; "it doesn't exist"?&nbsp;&nbsp;WHY ELSE would they move it?

&nbsp;
and just in case anyone missed Morse's list (as if!) I'll put it here too.&nbsp; I suppose the next thing is they'll move it to another section of the side effects instead of Nervous System !&nbsp;

&nbsp;

"...Nervous system - Frequent: amnesia, confusion, depersonalization, hypesthesia, thinking abnormal, trismus, vertigo; Infrequent: akathisia, apathy, ataxia, circumoral paresthesia, CNS stimulation, emotional lability, euphoria, hallucinations, hostility, hyperesthesia, hyperkinesia, hypotonia, incoordination, libido increased, manic reaction, myoclonus, neuralgia, neuropathy, psychosis, seizure, abnormal speech, stupor, suicidal ideation; Rare: abnormal/changed behavior, adjustment disorder, akinesia, alcohol abuse, aphasia, bradykinesia, buccoglossal syndrome, cerebrovascular accident, feeling drunk, loss of consciousness, delusions, dementia, dystonia, energy increased, facial paralysis, abnormal gait, Guillain-Barre Syndrome, <FONT size=7><STRONG>homicidal ideation,</STRONG></FONT> hyperchlorhydria, hypokinesia, hysteria, impulse control difficulties, motion sickness, neuritis, nystagmus, paranoid reaction, paresis, psychotic depression, reflexes decreased, reflexes increased, torticollis...."

&nbsp;

&nbsp;
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Joined: January 1st, 1970, 12:00 am

January 24th, 2008, 11:24 am #9

on NATIONAL RADIO
GOOD (re National Radio, not re their moving it) n/t
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Joined: January 1st, 1970, 12:00 am

January 24th, 2008, 11:25 am #10

<SPAN class=postbody><FONT color=#006699 size=2>http://www.network54.com/Forum/281849/m ... tion</FONT><FONT size=2>

MHRA admit to receiving 3 yellow cards on Venlafaxine side effect homicidal ideation
June 23 2006 at 6:23 PM morse
CONFIDENTIAL

Mr Jeremy Bryce
********* *****
***********
****** ****
Northern Ireland
*** ***

21 December 2005 MHRA Reference: LQ05/3453


Dear Mr Bryce


Thank you for your telephone call,requesting information on the side effect homicidal ideation in association with venlafaxine (Efexor).


As you may be aware the Yellow Card Scheme is the UK system for collecting and monitoring information on suspected adverse drug reactions (ADRs).The Scheme is run by the MHRA on behalf of the Commission on Human Medicines (CHM). Reports of suspected adverse drug reactions are held on a purpose-designed computer database known as the Adverse Drug Reactions On-line Information Tracking (ADROIT) database.


I have searched the ADROIT database and to date we have received a total of 3 suspected Adverse Drug Reaction reports of homicidal ideation in association with venlafaxine. This number is very small when you consider the usage of venlafaxine in the United Kingdom. It is also important to note that the inclusion of a particular reaction on the ADROIT database does not necessarily mean that it has been caused by the drug. Many factors have to be taken into account in assessing causal relationships including temporal association, the possible contribution of concomitant medication, and the underlying disease.

The current Product Information Leaflet (PIL) for venlafaxine recognises aggression as a side effect.

Further to your question regarding the differences that exist between the product information for venlafaxine in the UK compared with that in the US, with the latter recognising homicidal ideation as a suspected Adverse Drug Reaction. It is important to appreciate that it is not unusual for there to be differences in the UK and US information for medicinal products due to differences in the strengths of the medicines available and sometimes differences in the medical conditions which the products are licensed to treat.




SK LQ05/3453.doc 21/12/2005KC 1


I hope this information is helpful
Yours sincerely
Miss Shahin Kauser BSc (Hons)
Senior Pharmacovigilance Scientist
Room 15-257
Pharmacovigilance Group
Post-Licensing Division</FONT></SPAN>
If they had 3 by 2005, guessing they must be hiding the ones they've had since? n/t
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