Forest Laboratories, Inc. Announces Positive Results of LEXAPRO(R) Phase III Study in Adolescents With Major Depression
... subsequent SEC filings.
1. Jellinek MS, Snyder JB. Depression and
suicide in children and adolescents. Pediatr Rev 1998;19: 255-64. Birmaher B, ... effects of regulators' suicidality warnings on SSRI prescriptions and
suicide in children and adolescents. Am J Psychiatry. 2007 Sep; ...
Video: FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia
... seizures in the past, or who have conditions that increase their risk for seizures.
Call your doctor right away if you start thinking about
suicide or wanting to hurt yourself.
In a study of people taking INVEGA((R)) SUSTENNA(TM), common side effects in the treatment of schizophrenia were ...
FDA Advisory Committee Votes in Favor of Zyprexa for Two Adolescent Indications
... incidence of cerebrovascular adverse events in elderly patients with dementia-related psychosis treated with Zyprexa.
The possibility of a
suicide attempt is inherent in schizophrenia and bipolar I disorder. Close supervision of high-risk patient should accompany drug therapy.
As with all ...
RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment Delayed the Time to Relapse in Patients with Bipolar I Disorder
... has been reported.
Administration: Care should be taken to avoid inadvertent injection into a blood vessel.
Suicide: The possibility of
suicide attempt is inherent in psychotic illnesses. Close supervision of high-risk patients should accompany drug therapy.
Increased sensitivity in ...
Schering-Plough Highlights Hepatitis C Clinical Data Presentations at the European Association for the Study of the Liver (EASL) Annual Meeting
... injection site reactions or inflammation.
Individual serious adverse reactions occurred at a frequency less than or equal to 1% and included
suicide attempt, suicidal ideation, severe depression; psychosis, aggressive reaction, relapse of drug addiction/overdose; nerve palsy (facial, oculomotor); ...
Ground-Breaking Combination of All-Oral Agents Demonstrates Potential as Hepatitis C Treatment Regimen
... (16 percent).
Serious adverse events in hepatitis C trials included neuropsychiatric disorders (homicidal ideation, suicidal ideation,
suicide attempt, suicide, psychotic disorder and hallucinations), serious and severe bacterial infections (sepsis), bone marrow toxicity (cytopenia and ...
Roche and Pharmasset Initiate Phase IIb Clinical Trial of R7128, Most Advanced Nucleoside Polymerase Inhibitor in Development for Chronic Hepatitis C
... dermatitis (16 percent).
Serious adverse events in hepatitis C trials included neuropsychiatric disorders (homicidal ideation, suicidal ideation,
suicide attempt, suicide, psychotic disorder and hallucinations), serious and severe bacterial infections (sepsis), bone marrow toxicity (cytopenia and ...
Final Results of Boceprevir Phase II HCV SPRINT-1 Study Showed Significantly Higher SVR Rates Compared to Standard of Care in Treatment-Naive Genotype 1 Hepatitis C Patients
... injection site reactions or inflammation.
Individual serious adverse reactions occurred at a frequency less than or equal to 1% and included
suicide attempt, suicidal ideation, severe depression; psychosis, aggressive reaction, relapse of drug addiction/overdose; nerve palsy (facial, oculomotor); ...
FDA Approves an Expanded Indication for Peginterferon-Based Combination Therapy for Patients With Chronic Hepatitis C
... for injection site reactions or inflammation.
Individual serious adverse reactions occurred at a frequency less than or equal to 1% and included
suicide attempt, suicidal ideation, severe depression; psychosis, aggressive reaction, relapse of drug addiction/overdose; nerve palsy (facial, oculomotor); ...
New Study Shows that PEGASYS(R) Regimen Provides Higher Sustained Virological Response Rates for Hepatitis C Patients
... dermatitis (16 percent).
Serious adverse events in hepatitis C trials included neuropsychiatric
disorders (homicidal ideation, suicidal ideation,
suicide attempt, suicide,
psychotic disorder and hallucinations), serious and severe bacterial
infections (sepsis), bone marrow toxicity (cytopenia and ...
American Lung Association Study Finds No Evidence of Depression or Suicide Linked to Asthma and Allergy Drug Montelukast
... WASHINGTON, Sept. 1 /PRNewswire-USNewswire/ -- There has been recent
concern that
suicide may be a complication of montelukast (Singulair)
therapy. Montelukast is a Food and Drug Administration (FDA) approved oral
drug that has been ...
Pharmasset Reports Preliminary Results of a 4-week Combination Study of R7128 for the Treatment of Chronic Hepatitis C
... 7 for noncompliance with the protocol.
One SAE of suicidal ideation was reported in a patient with significant
psychiatric history (including prior
suicide attempts) who was two weeks
beyond the 28 days of dosing with R7128 and remaining on SOC.
Dr. Michelle Berrey, Pharmasset's Chief Medical Officer, ...
More Than 300 New Medicines Being Developed for Mental Illnesses
... Pantoliano --
well known for his role in The Sopranos -- who suffers from depression.
In Louisiana, rates of post-traumatic stress disorder and
suicide have
increased since hurricanes Katrina and Rita, according to the National
Institute on Drug Abuse. Mental disorders after a natural disaster ...
VA Statement on Smoking Cessation Research Program
... requested patients to come in and discuss possible side
effects of which they should be aware; these professionals felt that the
issue of
suicide should be discussed in a clinical setting, not in a
mailing to a group of patients.
The implication that a modest payment for volunteers in ...
U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
... have been associated with
antipsychotic drug use, including ABILIFY; use caution in patients at risk
for aspiration pneumonia.
The possibility of a
suicide attempt is inherent in psychotic
illnesses, bipolar disorder, and major depressive disorder, and close
supervision of high-risk patients should ...
Roche responds to announcement of 'IDEAL' hepatitis C trial results
... and dermatitis (16%).
Serious adverse events in hepatitis C trials included neuropsychiatric
disorders (homicidal ideation, suicidal ideation,
suicide attempt, suicide,
psychotic disorder and hallucinations), serious and severe bacterial
infections (sepsis), bone marrow toxicity (cytopenia and ...
AstraZeneca Submits sNDAs for SEROQUEL XR(TM) for the Treatment of Bipolar Mania and Bipolar Depression
... J Clin Psychiatry. 2003; 64:161-174.
10. Oquendo MA, Chaudhury SR, Mann JJ. Pharmacotherapy of Suicidal Behavior in Bipolar Disorder. Arch
suicide Res. 2005; 9(3):237-250.
...
European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
... Serious psychiatric adverse experiences, including severe depression
(2.4%), suicidal ideation (0.7%), nonfatal
suicide attempts (0.5%),
aggressive behavior (0.4%), paranoid reactions (0.4%), and manic reactions
(0.2%), have been reported in patients receiving ...
Bristol-Myers Squibb and Gilead Sciences Expand Their Alliance to Include Commercialization of ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) in Europe
... Serious psychiatric adverse experiences, including severe depression
(2.4%), suicidal ideation (0.7%), nonfatal
suicide attempts (0.5%),
aggressive behavior (0.4%), paranoid reactions (0.4%), and manic reactions
(0.2%), have been reported in patients receiving ...
Treatment with PEGASYS(R)/COPEGUS(TM) Provides Hope for Hepatitis C Patients Whose Infection Did Not Initially Respond to Peg-Intron(R)/Ribavirin
... and dermatitis (16%). Serious adverse events in hepatitis C trials included neuropsychiatric
disorders (homicidal ideation, suicidal ideation,
suicide attempt, suicide,
psychotic disorder and hallucinations), serious and severe bacterial
infections (sepsis), bone marrow toxicity (cytopenia and ...
Roche's Investigational Polymerase Inhibitor, Combined with PEGASYS(R) and COPEGUS(TM), Shows Potent Antiviral Activity in Treatment of Chronic Hepatitis C at Four Weeks
... and dermatitis (16%). Serious adverse events in hepatitis C trials included neuropsychiatric
disorders (homicidal ideation, suicidal ideation,
suicide attempt, suicide,
psychotic disorder and hallucinations), serious and severe bacterial
infections (sepsis), bone marrow toxicity (cytopenia and ...
European CHMP Issues Positive Opinion for ATRIPLA(R) (efavirenz 600 mg/ emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)
... Serious psychiatric adverse experiences, including severe depression
(2.4%), suicidal ideation (0.7%), nonfatal
suicide attempts (0.5%),
aggressive behavior (0.4%), paranoid reactions (0.4%), and manic reactions
(0.2%), have been reported in patients receiving ...
Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
... Serious psychiatric adverse experiences, including severe depression
(2.4%), suicidal ideation (0.7%), nonfatal
suicide attempts (0.5%),
aggressive behavior (0.4%), paranoid reactions (0.4%), and manic reactions
(0.2%), have been reported in patients receiving ...
Data Suggest that Pegasys May be an Option in Hepatitis C Patients
Unable to Tolerate Peg-Intron
... trouble with drug addiction or overdose,
thoughts about suicide,
suicide attempts,
suicide and thoughts
about homicide)
-- Blood problems (like a drop in blood ...
Pegasys Study Authors Conclude that Patients Successfully Treated
for Hepatitis C Can be Considered ''Cured''
... trouble with drug addiction or overdose,
thoughts about suicide,
suicide attempts,
suicide and thoughts
about homicide)
-- Blood problems (like a drop in blood ...
New Study Analyses Confirm Once-Daily Seroquel XR Extended-Release
Tablets as Effective Treatment for Schizophrenia
... cataracts, seizures, hyperlipidemia, and possibility
of
suicide attempt. Examination of the lens by methods adequate to
detect cataract ... and at 6-month intervals during
chronic treatment. The possibility of a
suicide attempt is inherent
in schizophrenia, and close supervision of high risk ...
Corcept Therapeutics Announces Phase 3 Study Evaluating Corlux for
Psychotic Major Depression Misses Primary Endpoint
... characterized by severe depression accompanied by
delusions, hallucinations or both. People with PMD are
approximately 70 times more likely to commit
suicide than the
general population and often require lengthy and expensive hospital
stays. There is no FDA-approved treatment for PMD.
About Corcept ...
Protein Found to Shield Pancreatic Cancer Cells from
Self-Destruction
... the M. D. Anderson team shows in lab experiments that
inhibiting the protein in pancreatic cancer cells leads to a form
of programmed cell
suicide called autophagy, or self-digestion.
TG2 was inhibited in two separate ways. First, the researchers
blocked another protein known to activate TG2. ...
Six-Week Investigational Study In Adults With Major Depressive
Disorder Evaluates The Effectiveness of Adjunctive Aripiprazole
Therapy With Antidepressants
... esophageal
dysmotility and aspiration, aripiprazole should be used cautiously
in patients at risk for aspiration pneumonia.
As the possibility of a
suicide attempt is inherent in psychotic
illness and bipolar disorder, close supervision of high-risk
patients should accompany drug therapy. Prescriptions ...
Blood Levels of Paliperidone Extended-Release Tablets are Not
Increased by Common Antidepressant
... dopamine
D2 receptors, paliperidone elevates prolactin levels and the
elevation persists during chronic administration.
Suicide: The possibility of
suicide attempt is inherent in
psychotic illnesses and close supervision of high-risk patients
should accompany drug therapy.
Maintenance treatment: ...
Study Suggests Strattera Improved ADHD Symptoms in Patients With
Comorbid Alcohol Abuse
... with Strattera did not
reveal an increased risk of suicidal thoughts. Parents should call
their doctor right away if their child has thoughts of
suicide or
sudden changes in mood or behavior, especially at the beginning of
treatment or after a change in dose. Strattera should not be taken
at the same ...
Investigational Study Evaluates the Effectiveness of Aripiprazole
in Adolescents With Schizophrenia
... esophageal
dysmotility and aspiration, aripiprazole should be used cautiously
in patients at risk for aspiration pneumonia.
As the possibility of a
suicide attempt is inherent in psychotic
illness and bipolar disorder, close supervision of high-risk
patients should accompany drug therapy. Prescriptions ...