Arthur Bueno on Thu, 16 Sep 1999 20:54:20 +0200


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Syndicate: XANAX PLACEBO


Date: Thu, 16 Sep 1999 01:29:44 -0800
From: /m/e/t/a/ <meta@null.net>

Xanax Tablets contain alparzolam which is a triazolo analog of the
1,4-benzodiazepine class of central nervous system-active compounds.

The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo
[4,3-alpha][1,4]benzodiazepine.

Inactive ingredients: Cellulose, corn starch, docusate sodium, lactose,
magnesium strearate, silicon dioxide and sodium benzoate. In addition, the
0.5 mg tablet contains FD& C Yellow No. 6 and the 1 mg tablet contains FD&
C Blue No. 2.



 09/13/99
      DG DISPATCH - EFNS: Depression Commonly Misdiagnosed As Dementia
      Early Treatment Improves HIV-Related Dementia
 09/09/99
      Attenade Effective In the Treatment Of ADD And ADHD
      Communication Training, Drug Therapy Combination Greatly Reduces
Self-Injury
 08/31/99
      Alcohol Researchers Identify Medication That Lessens Relapse Risk
 08/18/99
      IPA MEETING: Aricept Effective In Long-Term Treatment Of Alzheimer's
 08/17/99
      IPA CONGRESS: Aricept Effective, Well-Tolerated For Long-Term
Alzheimer's Treatment
 08/10/99
      PSYCHIATRY CONGRESS: Seroquel Effective Treatment For Schizophrenia
In Partial Responders
 08/06/99
      PSYCHIATRY CONGRESS: Paxil Effective Treatment For Social Anxiety
Disorder
 08/03/99
      Boys Treated With Stimulants Less Likely To Abuse Drugs As Adults
 08/02/99
      Chronic, Heavy Cocaine Use Associated With Long-Lasting Impaired
Function
      ISP CONGRESS: Zyprexa Reduces Hyperprolactinemia Prevalence In
Schizophrenia Patients
 07/12/99
      Neurontin Reduces Symptoms Of Social Phobia


       Discontinuation-Emergent Symptom Incidence
 Percentage of 641 Xanax-Treated Panic Disorder Patients
                   Reporting Events

Body System/Event

Neurologic                      Gastrointestinal
 Insomnia              29.5      Nausea/Vomiting         16.5
 Lightheadedness       19.3      Diarrhea                13.6
 Abnormal involuntary            Decreased salivation    10.6
   movement            17.3
 Headache              17.0     Metabolic-Nutritional
 Muscular twitching     6.9      Weight loss             13.3
 Impaired Coordination  6.6      Decreased appetite      12.8
 Muscle tone disorders  5.9
 Weakness               5.8     Dermatological
Psychiatric                      Sweating                14.4
 Anxiety               19.2
 Fatigue and Tiredness 18.4     Cardiovascular
 Irritability          10.5      Tachycardia             12.2
 Cognitive disorder    10.3
 Memory impairment      5.5     Special Senses
 Depression             5.1      Blurred vision          10.0
 Confusional state      5.0




 07/05/99
      Clozapine May Restore Information Processing To Schizophrenia Patients
 06/29/99
      Depression In Breast Cancer Patients Linked To Lack Of Estrogen
      For Heart Disease Patients, Depression Takes Heavy Toll
      Once-Daily Adderall As Effective As Twice Daily For ADHD
 06/25/99
      DG DISPATCH - HEADACHE: Sumatriptan Non-Responders Often Have Other
Personality Disorders
 06/21/99
      ADA MEETING: Diabetes and Depression Enhance Each Other's Severity
and Cost
 06/18/99
      Zyprexa Reduces Symptoms Of Mania, Severe Depression In Bipolar Disorder
 06/17/99
      BIPOLAR DISORDERS MEETING: Researchers Find New Approach To Treating
Bipolar Disorder
      DG DISPATCH - ENDO 99: Anorexia Nervosa Linked To Serious Bone Loss
      Youth Stress Key Predictor Of Later Hypertension
 06/02/99
      Neotrofin Effective In Alzheimer's Disease Treatment
 05/28/99
      DG DISPATCH - APA MEETING: Cognitive Improvement Associated With
Olanzapine
 05/27/99
      DG DISPATCH - APA MEETING: Combination Treatment Often Necessary For
Bipolar Disorder
      DG DISPATCH - APA MEETING: HIV Infection Associated With Psychiatric
Symptoms
      DG DISPATCH - APA MEETING: Overview Of Treatment For Bipolar Disorder
 05/25/99
      AGS MEETING: ProMem Improves Symptoms Of Alzheimer's
      Low Cholesterol Levels May Be Linked To Depression, Anxiety
      Smoking And Depression Weakens Immune System
 05/21/99
      APA MEETING: Seroquel Improves Psychotic Symptoms Of Alzheimer's,
Parkinson's Diseases


Anxiety Disorders
                                                     Incidence of
                                                     Intervention
                              Treatment-Emergent     Because of
                              Symptom Incidence(1)   Symptom
                               XANAX    PLACEBO       XANAX
Number of Patients              565       505          565
% of Patients Reporting:
CENTRAL NERVOUS SYSTME
   Drowsiness                   41.0      21.6         15.1
   Lightheadedness              20.8      19.3          1.2
   Depression                   13.9      18.1          2.4
   Headache                     12.9      19.6          1.1
   Confusion                     9.9      10.0          0.9
   Insomnia                      8.9      18.4          1.3
   Nervousness                   4.1      10.3          1.1
   Syncope                       3.1       4.0          *
   Dizziness                     1.8       0.8          2.5
   Akathisia                     1.6       1.2          *
   Tiredness/Sleepiness          *         *            1.8
GASTOINTESTINAL
   Dry Mouth                    14.7      13.3          0.7
   Constipation                 10.4      11.4          0.9
   Diarrhea                     10.1      10.3          1.2
   Nausea/Vomiting               9.6      12.8          1.7
   Increased Salivation          4.2       2.4          *
CARDIOVASCULAR
   Tachycardia/Palpitations      7.7      15.6          0.4
   Hypotension                   4.7       2.2          *
SENSORY
   Blurred Vision                6.2       6.2          0.4
MUSCULOSKELETAL
   Rigidity                      4.2       5.3          *
   Tremor                        4.0       8.8          0.4
CUTANEOUS
   Dermatitis/Allergy            3.8       3.1          0.6
OTHER
   Nasal Congestion              7.3       9.3          *
   Weight Gain                   2.7       2.7          *
   Weight Loss                   2.3       3.0          *

Notes:   *  None reported
        (1) Events reported by 1% or more of Xanax patients
            are included.




 05/20/99
      APA MEETING: Seroquel Appears To Work In Some Bipolar And
Schizoaffective Patients
 05/19/99
      APA MEETING: Effexor Produces Superior Remission Rates To SSRIs
      APA MEETING: Effexor XR Produces Significant Relief From Depression
In First Week of Treatment
      APA MEETING: Once-Daily Adderall More Effective Than Ritalin For ADHD
 05/18/99
      APA MEETING: Drug-Psychotherapy Combo Effective For Chronic Depression
      APA MEETING: Early Response To Zoloft Indicative Of Future Success In
Panic Disorder Treatment
      Prozac Tablet To Be Available In The U.S. June 1, 1999
      Reboxetine Effective In Treating Depression Symptoms
 05/17/99
      APA MEETING: Electromagnetic Stimulation Shows Promise For
Treatment-Resistant Depression
      APA MEETING: Zaleplon Effective Against Insomnia Without Residual
Effects
      Greater Orgasm Dysfunction Found In Patients Taking Zoloft Than
Wellbutrin SR
 05/14/99
      SBP MEETING: Risperdal Significantly Decreases Schizophrenia Relapse
Risk
 05/13/99
      Researchers Look To Omega-3 Fatty Acid For Manic Depression Treatment
      Study Shows Psychotherapy As Effective As Drug Therapy For Atypical
Depression
 05/11/99
      Adolescent Depression Often Continues To Adulthood
      FDA Approves Paxil In The U.S. For Social Anxiety Disorder
 05/06/99
      Paxil Approved In Canada For Social Anxiety Disorder
 05/03/99
      Newest Depression Treatments Widely Prescribed For Children
 04/30/99
      Luvox Effective For Treating Social Phobia
 04/28/99
      AANS MEETING: Study Shows Depression In Brain Tumor Patients May Go
Untreated
 04/26/99
      DG DISPATCH - AAN: Autism Linked To Smaller Volumes In Hippocampus
And Amygdala
      DG DISPATCH - AAN: Metifronate Improves Psychiatric Profile Of
Patients With Alzheimer's Disease
 04/21/99
      Risperdal Improves Learning Capacity, Skills Acquisition For
Schizophrenia Patients
 04/20/99
      DG Dispatch - AAN: Significant Differences Found In Male And Female
Brains
 04/19/99
      Ampalex Produces Cognition Improvement In Schizophrenia Patients
      DG Dispatch - AAN: Differences In Brain Size Found In Hyperactive
Children


Panic Disorder
                                     Treatment-Emergent
                                     Symptom Incidence*
                                    XANAX        PLACEBO
Number of Patients                   1388          1231
% of Patients Reporting:
CENTRAL NERVOUS SYSTEM
   Drowsiness                        76.8          42.7
   Fatigue and Tiredness             48.6          42.3
   Impaired Coordination             40.1          17.9
   Irritability                      33.1          30.1
   Memory Impairment                 33.1          22.1
   Lightheadedness/Dizziness         29.8          36.9
   Insomnia                          29.4          41.8
   Headache                          29.2          35.6
   Cognitive Disorder                28.8          20.5
   Dysarthria                        23.3           6.3
   Anxiety                           16.6          24.9
   Abnormal Involuntary Movement     14.8          21.0
   Decreased Libido                  14.4           8.0
   Depression                        13.8          14.0
   Confusional State                 10.4           8.2
   Muscular Twitching                 7.9          11.8
   Increased Libido                   7.7           4.1
   Change in Libido (Not Specified)   7.1           5.6
   Weakness                           7.1           8.4
   Muscle Tone Disorders              6.3           7.5
   Syncope                            3.8           4.8
   Akathisia                          3.0           4.3
   Agitation                          2.9           2.6
   Disinhibition                      2.7           1.5
   Paresthesia                        2.4           3.2
   Talkativeness                      2.2           1.0
   Vasomotor Disturbances             2.0           2.6
   Derealization                      1.9           1.2
   Dream Abnormalities                1.8           1.5
   Fear                               1.4           1.0
   Feeling Warm                       1.3           0.5
GASTROINTESTINAL
   Decreased Salivation              32.8          34.2
   Constipation                      26.2          15.4
   Nausea/Vomiting                   22.0          31.8
   Diarrhea                          20.6          22.8
   Abdonimal Distress                18.3          21.5
   Increased Salivation               5.6           4.4
CARDIO-RESPIRATORY
   Nasal Congestion                  17.4          16.5
   Tachycardia                       15.4          26.8
   Chest Pain                        10.6          18.1
   Hyperventilation                   9.7          14.5
   Upper Respiratory Infection        4.3           3.7
SENSORY
   Blurred Vision                    21.0          21.4
   Tinnitus                           6.6          10.4
MUSCULOSKELETAL
   Muscular Cramps                    2.4           2.4
   Muscle Stiffness                   2.2           3.3
CUTANEOUS
   Sweating                          15.1          23.5
   Rash                              10.8           8.1
OTHER
   Increased Appetite                32.7          22.8
   Decreased Appetite                27.8          24.1
   Weight Gain                       27.2          17.9
   Weight Loss                       22.6          16.5
   Micturition Difficulties          12.2           8.6
   Menstrual Disorders               10.4           8.7
   Sexual Dysfunction                 7.4           3.7
   Edema                              4.9           5.6
   Incontinence                       1.5           0.6
   Infection                          1.3           1.7

Note:  * Events reported by 1% or more of Xanax patients are included.




 04/08/99
      Genetic, Familial Factors Influence ADHD
 04/05/99
      Adderall As Effective, Longer-Lasting Than Ritalin For ADHD
 03/26/99
      ADAA MEETING: Effexor XR Effective In Treating Symptoms Of
Generalised Anxiety Disorder
 03/24/99
      SSRI Antidepressants Effective In Young Patients With Body Dysmorphic
Disorder
 03/23/99
      ACS MEETING: Improved Ritalin Offers Smaller Doses And Fewer Side
Effects
      SGO MEETING: Women With Ovarian Cancer Have Higher Rates Of
Depression, Anxiety
 03/22/99
      Social Support May Extend Life Of People With Schizophrenia
      Treating Depression, Anxiety, Alcohol Abuse Significantly Reduces
Teen Suicide Risk
      Vision Problems, Not Confusion, Cause Alzheimer's Patients To Become
Lost
 03/18/99
      Newer Antidepressant Drugs As Effective As Older-Generation Treatments
 03/16/99
      AAGP MEETING: Seroquel Effective At Treating Psychosis In Patients
With Alzheimer's, Parkinson's
      Cognitive-Behaviour Therapy And Drug Treatments Effective In Treating
Late-Life Insomnia
 03/12/99
      Effexor XR Approved In The U.S. For Anxiety


                                    XANAX         PLACEBO
                                  Low  High      Low  High
Hematology
   Hematocrit                     *    *         *    *
   Hemoglobin                     *    *         *    *
   Total WBC Count                1.4  2.3       1.0  2.0
   Neutrophic Count               2.3  3.0       4.2  1.7
   Lymphocyte Count               5.5  7.4       5.4  9.5
   Monocyte Count                 5.3  2.8       6.4  *
   Eosinophil Count               3.2  9.5       3.3  7.2
   Basophil Count                 *    *         *    *
Urinalysis
   Albumin                        -    *         -    *
   Sugar                          -    *         -    *
   RBD/HPF                        -    3.4       -    5.0
   WBC/HPF                        -   25.7       -   25.9
Blood Chemistry
   Creatinine                     2.2  1.9       3.5  1.0
   Bilirubin                      *    1.6       *    *
   SGOT                           *    3.2       1.0  1.8
   Alkaline Phosphatase           *    1.7       *    1.8

Note:  * Less than 1%




 03/10/99
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 03/05/99
      Depression Linked To Reduced Blood Pressure Control
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 03/04/99
      Memantine Effective For Patients With Severe Dementia
 03/01/99
      Continued Treatment With Prozac Reduces Panic Attack Frequency
 02/15/99
      Lower Serotonin Levels Linked To Relapses In Bulimia Nervosa
      Most Patients With Obsessive-Compulsive Disorder Improve After
Several Decades
 02/11/99
      Adding Natural Hormone Boosts Brain Function In Hypothyroidism
 02/10/99
      Celexa Approved In Canada For Treatment Of Depression
 02/05/99
      No Relationship Between Dental Amalgam And Alzheimer's Disease
 01/29/99
      Depression Linked To Higher Death Risk
      Women At Greater Risk Of Depression After Heart Attack
 01/08/99
      Frequent Digestion Complaints May Point To Psychiatric Disorders
      Research Shows No Link Between Mononucleosis And Depression
 01/05/99
      Psychotherapy And Nortriptyline Effective For Recurrent Depression In
Elderly
 01/04/99
      Risk Of Schizophrenia Onset Linked To Brain Abnormalities
 12/16/98
      ACN MEETING: Seroquel More Effective Than Risperidone In Minimising EPS
      ACN MEETING: Seroquel Shown To Be Effective For Alzheimer's, Parkinson's
 12/15/98
      ACN MEETING: Zyprexa Reduces Behavioural, Psychiatric Symptoms
Related To Alzheimer's
      Behavioural Therapy Effective In Treating Urinary Incontinence
      Risperdal Reduces Dementia And Other Psychoses In Elderly Patients


      XANAX Tablets are available as follows:
0.25 mg (white, oval, scored)
Bottles of 100 NDC 0009-0029-01
Reverse Numbered Unit Dose (100) NDC 0009-0029-46
Bottles of 500 NDC 0009-0029-02
Bottles of 1000 NDC 0009-0029-14
0.5 mg (peach, oval, scored)
Bottles of 100 NDC 0009-0055-01
Reverse Numbered Unit Doses (100) NDC 0009-0055-46
Bottles of 500 NDC 0009-0055-03
Bottles of 1000 NDC 0009-0055-15
1 mg (blue, oval, scored)
Bottles of 100 NDC 0009-0090-01
Reverse Numbered Unit Dose (100) NDC 0009-0090-46
Bottles of 500 NDC 0009-0090-04
Bottles of 1000 NDC 0009-0090-13
2 mg (white, oblong, multi-scored)
Bottles of 100 NDC 0009-0094-01
Bottles of 500 NDC 0009-0094-03



 12/11/98
      One-Third Of Children In Road Traffic Accidents Develop Stress Disorder
 12/04/98
      Researchers Find New Indicators For Alzheimer's Disease
 11/24/98
      Five Top Warning Signals Of Depression Identified
      Sertraline Found Safe And Effective For Obsessive-Compulsive Disorder
In Children
      Tacrine Slows Cognitive Deterioration For Alzheimer's Patients
 11/23/98
      Childhood Loss Linked To Later Health Problems
 11/17/98
      Sertraline Beneficial For Ongoing Treatment Of Chronic Depression
 11/16/98
      Study Shows Prozac Can Reduce Symptoms Of Panic Disorder
 11/10/98
      Chronic Stress Puts Heart Disease Patients At Greater Risk
 11/03/98
      Remeron More Effective, Faster Working Than Cipramil or Paxil, Study
Shows
 10/30/98
      Evidence Of Brain Injury In Ecstasy Users
      Olanzapine More Tolerable, As Effective As Clozaril For
Treatment-Resistant Patients
 10/29/98
      Serious Crime Victims Risk PTSD, Multiple Disorders
 10/28/98
      Treatment of Depression May Help Reduce Mortality In Older Women
 10/22/98
      Older Adults' Speech-Processing Difficulties May Stem From Fast,
Noisy Talk, Not Deafness
      Prenatal Cocaine Exposure Leads To Lower IQ Scores, Language Skills
 10/20/98
      Elevated Homocysteine Levels May Be Possible Risk Factor For
Alzheimer Disease
 10/19/98
      FDA Approves Versed Syrup For Pediatric Pre-Operative Sedation
 10/15/98
      Altered Brain Chemistry In Bulimia Nervosa Patients Persists After
Recovery
 10/08/98
      Seroxat/Paxil Approved In UK For Social Anxiety Disorder






"From morning till evening and on through the night we are floating upon
processes and systems that we don't understand."

















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