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INTERNATIONAL WARNINGS AND STUDIES ON PSYCHIATRIC DRUGS
Your filter specification: Side Effects: Homicidal Actions, Homicidal Ideation, Hostility, Sudden Death, Suicidal Risk, Suicide, Suicide Attempts, Suicide Risk, Country: United
States
49 Entries Found

Drug Warning, April 01, 2011
Drug Class: Antidepressant,
Generic Name: Bupropion,
Brand Name: Aplenzin,

United States

Age: Adults (18 and over)
Side Effects: Agitation, Suicide, Suicide Attempts, Suicide Risk,
Summary: The FDA issued label changes to the antidepressant Aplenzin. The new label now includes in its adverse reactions and precautions section, agitation and
completed suicides.
Source: "Aplenzin (bupropion hydrobromide) Extended-Release Tablets", FDA , April 2011, http://www.fda.gov/Safety/edWatch/SafetyInformation/ucmm254108.htm

Drug Study, February 22, 2011
Drug Class: Antidepressant,
Generic Name: Paroxetine,
Brand Name: Paxil, Seroxat,

United States

Age: Adults (18 and over)
Side Effects: Suicide Risk, Suicide Attempts, Suicide,
Summary: The Journal of Clinical Psychiatry published a study where researchers found that, across all disorders, overall suicidality incidence was similar between
paroxetine and placebo. In addition, a higher frequency of suicidal behavior occurred with paroxetine in treatment of major depressive disorder.
Source: David J. Carpenter, MSc, PharmD, et al., "Meta-Analysis of Efficacy and Treatment-Emergent Suicidality in Adults by Psychiatric Indication and Age Subgroup
Following Initiation of Paroxetine Therapy: A Complete Set of Randomized Placebo-Controlled Tria

Drug Study, December 01, 2010
United States
Drug Class: Mood Stabilizer, Antianxiety, Antidepressant, Antipsychotic, Stimulant,
Generic Name: Fluoxetine, Paroxetine, Fluvoxamine, Venlafaxine, Desvenlafaxine, Sertraline, Escitalopram, Citalopram, Amitriptyline, Bupropion, Trazodone, Mirtazapine,
Duloxetine, Amphetamines, Atomoxetine, Methylphenidate, Levetiracetam, Oxcarbazepine, Topiramate, Lamotrigine, Valproic Acid, Phenytoin, Carbamazepine,
Aripiprazole, Ziprasidone, Risperidone, Quetiapine, Olanzapine, Paliperidone, Clozapine, Triazolam, Zolpidem, Eszopiclone, Diazepam, Alprazolam, Clonazepam,
Midazolam, Lorazepam,
Brand Name: Prozac, Paxil, Seroxat, Luvox, Effexor, Pristiq, Zoloft, Lexapro, Celexa, Elavil, Endep, Vanatrip, Wellbutrin, Zyban, Desyrel, Oleptro, Remeron, Cymbalta,
Strattera, Ritalin, Concerta, Keppra, Trileptal, Topamax, Topiragen, Lamictal, Depakote, Depakene, Depacon, Epilim, Di-Phen, Dilantin, Phenytek, Carbatrol, Epitol,
Equetro, Tegretol, Abilify, Geodon, Risperdal, Seroquel, Zyprexa, Invega, Clozaril, Halcion, Ambien, Lunesta, Valium, Xanax, Klonopin, Versed, Ativan,
Age: Adults (18 and over), Children (under 18)
Side Effects: Violence, Homicidal Ideation, Homicidal Actions,
Summary: The authors of a study in PLoS One took the Food and Drug Administration's Adverse Event Reporting System data, and extracted all "serious adverse event"
reports for drugs with 200 or more cases received from 2004 through September 2009. They identified 484 drugs, which accounted for 780,169 serious adverse event
reports of all kinds, including 1,937 cases meeting their violence criteria. Of the 484 drugs identified, 31 drugs were disproportionately associated with violence. These
drugs, accounting for 79% of all the violence cases, included 11 antidepressants, 6 sedative/hypnotics and 3 drugs for attention deficit hyperactivity disorder. The specific
cases of violence included: homicide, physical assaults, cases indicating physical abuse, homicidal ideation, and cases described as violence-relates symptoms. The
authors concluded, "These data provide new evidence that acts of violence towards others are a genuine and serious adverse drug event that is associated with a
relatively small group of drugs.
Source: Thomas J. Moore, Joseph Glenmullen, Curt D. Furbert, "Prescription Drugs Associated with Reports of Violence Towards Others," Public Library of Science ONE,
Vol. 5, Iss. 12, Dec. 2010.

Drug Study, April 14, 2010
Drug Class: Mood Stabilizer,
Generic Name: Topiramate, Carbamazepine,
Brand Name: Topamax, Topiragen, Carbatrol, Epitol, Equetro, Tegretol,

United States

Age: Adults (18 and over)
Side Effects: Suicide Risk, Suicide Attempts, Suicide,
Summary: A study published in the Journal of the American Medical Association evaluated the risk of suicidal acts and combined suicidal acts or violent death associated
with individual anticonvulsants (used to treat bipolar disorder and mania). The author's conclusion was essentially that some anticonvulsants have a higher risk of
suicidal acts/violent deaths then others. However, they also acknowledge that anticonvulsant medications in general can have psychotropic effects, including mood and
behavior changes. Additionally, that their findings are compatible with the FDA analysis that warranted labeling on all anticonvulsant medications warning of the an
increased risk of suicidal thoughts and behaviors.
Source: Elisabetta Patorno, et al., "Anticonvulsant Medications and the Risk of Suicide, Attempted Suicide, or Violent Death," Journal of the American Medical
Association, vol. 303, no. 14, April 14, 2010.

Drug Study, January 01, 2010
Drug Class: Antidepressant,
Generic Name: Paroxetine, Venlafaxine,
Brand Name: Paxil, Seroxat, Effexor,

United States

Age: Children (under 18), Adults (18 and over)
Side Effects: Birth Defects, Death, Sudden Death,
Summary: A study published in Current Drug Delivery researched the "under evaluated" impact of antidepressant use during pregnancy on the risk of spontaneous
abortion. After reviewing the data collected, they said the information suggests fetal exposure to antidepressants, especially paroxetine and venlafaxine, can lead to
spontaneous abortion.

spontaneous abortion.
Source: Broy, Perrine and Berard, Anick., "Gestational Exposure to Antidepressants and the Risk of Spontaneous Abortion: A Review," Current Drug Delivery, Vol. 7, No.
1, January 2010.

Drug Warning, January 01, 2010
Drug Class: Antidepressant,
Generic Name: Venlafaxine,
Brand Name: Effexor,

United States

Age: Adults (18 and over)
Side Effects: Seizures, Tremors, Nausea, Vomiting, Skin Problems, Skin Reactions, Dizziness, Death, Sudden Death,
Summary: The FDA updated the warning label for Effexor stating that it should not be taken by patients taking or have taken MAOIs (monoamine oxidase inhibitors, used
to treat depression) within 14 days due to the risk of serious, sometimes fatal, drug interactions with SNRI or SSRI treatment. Some symptoms include tremor, nausea,
vomiting, flushing, dizziness.
Source: "Effexor (venlafaxineHCI) tablets and Effexor XR (venlafaxine HCI) extended-release capsule" FDA.gov, January 2010,
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm201064.htm

Drug Study, December 14, 2009
Drug Class: Antidepressant,
Generic Name:
Brand Name:

United States

Age: Adults (18 and over)
Side Effects: Heart Problems, Death, Sudden Death,
Summary: The Archives of Internal Medicine published a study that researched the relationship between antidepressants and the start of problems related to the heart and
blood vessels in postmenopausal women. The researchers found that tricyclic and SSRIs antidepressants may be associated with increased risk of mortality. SSRIs
additionally show an increased risk of excessive bleeding and fatal stroke.
Source: Jordan W. Smoller, MD, et al., "Antidepressant Use and Risk of Incident Cardiovascular Morbidity and Mortality Among Postmenopausal Women in the Women's
Health Initiative Study," Archives of Internal Medicine, Vol. 169, No. 22, December 14, 2009.

Drug Warning, July 01, 2009
Drug Class: Antidepressant, Antianxiety,
Generic Name: Bupropion,
Brand Name: Zyban, Wellbutrin,

United States

Age: Adults (18 and over)
Side Effects: Abnormal Behavior, Emotional Changes, Aggression, Violence, Hostility, Agitation, Irritability, Depression, Suicide Risk, Suicide Attempts, Suicide,
Summary: The FDA has required the manufacturers of the smoking cessation aid bupropion (Zyban, aka Wellbutrin) to add new Boxed Warnings and develop patient
Medication Guides highlighting the risk of serious neuropsychiatric symptoms in patients using this product. These symptoms include changes in behavior, hostility,
agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide.
Source: "Information for Healthcare Professionals: Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics)," FDA, July 1, 2009.

Drug Study, June 15, 2009
Drug Class: Stimulant,
Generic Name: Methylphenidate, Dextroamphetamine, Methamphetamine, Amphetamine,
Brand Name: Ritalin, Concerta, Dexedrine,

United States

Age: Children (under 18)
Side Effects: Death, Sudden Death,
Summary: The American Journal of Psychiatry published a study that provides support for an association between the use of stimulants and sudden unexplained death
among children and adolescents.
Source: Madelyn S. Gould, Ph.D., M.P.H., et al., "Sudden Death and Use of Stimulant Medications in Youths," The American Journal of Psychiatry, Vol AiA, June 15, 2009.

Drug Warning, June 01, 2009
United States
Drug Class: Stimulant,
Generic Name: Dexmethylphenidate, Dextroamphetamine, Lisdexamfetamine, Methamphetamine, Methylphenidate, Amphetamine and Dextroamphetamine, Pemoline,
Brand Name: Focalin, Focalin XR, Dexedrine, Dexedrine Spansule, Vyvanse, Dextrostat, Desoxyn, Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER,
Ritalin, Ritalin LA, Ritalin SR, Adderall, Adderall XR, Cylert,
Age: Children (under 18)
Side Effects: Death, Sudden Death,
Summary: The FDA reported on a study reviewing 564 healthy children taking stimulants who died suddenly. They notified the public that there might be an association
between the use of stimulant medications and sudden death in healthy children.
Source: "Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder - Communication about an Ongoing Safety Review," Food and Drug
Administration, June 15, 2009.

Drug Warning, May 05, 2009
Drug Class: Mood Stabilizer,
Generic Name: Carbamazepine,
Brand Name: Carbatrol, Epitol, Equetro, Tegretol,

United States

Age: Adults (18 and over)
Side Effects: Suicide Risk, Suicide Attempts, Suicide,
Summary: The FDA released a notification to healthcare professionals and patients of the approved label change for antiepileptic drugs used to treat psychiatric disorders,
and other conditions. The update on the drug's label now includes the increased risk of suicidal thoughts or behavior, which was generally consistent among the drugs.
Source: "2008 Safety Alerts for Human Medical Products (Drugs, Biologics, Medical Devices, Special Nutritionals, and Cosmetics)," FDA MedWatch, May 5, 2009.

Drug Warning, December 16, 2008
Drug Class: Mood Stabilizer,
Generic Name: Carbamazepine, Valproic Acid,
Brand Name: Carbatrol, Equetro, Tegretol, Depakote, Depakene, Depacon, Epilim,

United States

Age: Adults (18 and over)
Side Effects: Suicide Risk, Suicide Attempts, Suicide,
Summary: The FDA completed an analysis of reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical trials of drugs used to treat epilepsy,
psychiatric disorders, and other conditions. Based on the outcome of this review, the FDA now requires that all manufacturers of antiepileptic drugs include a warning in
their labeling and develop a Medication Guide to be provided to patients prescribed these drugs to inform them of the risks of suicidal thoughts or actions.
Source: "2008 Safety Alerts for Human Medical Products (Drugs, Biologics, Medical Devices, Special Nutritionals, and Cosmetics)," MedWatch, December 16, 2008.

Drug Warning, March 01, 2008
Drug Class: Mood Stabilizer,
Generic Name: Valproic Acid,
Brand Name: Depakote, Depakene, Depacon, Epilim,

United States

Age: Adults (18 and over)
Side Effects: Hypothermia, Suicide Risk, Suicide, Altered Thyroid Function,
Summary: FDA's MedWatch added a warning to Depakote (anticonvulsant) prescribed often to counter psych drug reactions and prevent seizures caused by them.
Depakote is also FDA approved to treat Mania. The packaging must now warn that Hypothermia (dropped body core temperature) has reported in association with
Depakote use; Suicidal ideation may manifest; and reports of altered thyroid function tests associated with valproate.
Source: "Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) - March 2008," FDA MedWatch, March 2008.

Drug Warning, February 01, 2008
Drug Class: Antidepressant,
Generic Name: Selegiline,
Brand Name: Emsam,

United States

Age: Children (under 18), Adults (18 and over)
Side Effects: Suicide Risk, Suicide Attempts, Suicide,
Summary: FDA's MedWatch added to the Emsam (antidepressant patch) safety label warnings of the potential for clinical worsening and suicide risk related to the use of
this drug. Furthermore, due to the limited data, Emsam at any dose should not be used in children under the age of 12 years even when administered with dietary
modifications. Emsam is not approved for use in pediatric patients.
Source: "Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) - February 2008," The FDA Safety Information and
Adverse Event Reporting Program, February 2008.

Drug Warning, January 31, 2008
Drug Class: Mood Stabilizer,
Generic Name: Carbamazepine, Valproic Acid, Gabapentin, Lamotrigine, Oxcarbazepine, Pregabalin, Topiramate,
Brand Name: Carbatrol, Equetro, Tegretol, Depakote, Depakene, Depacon, Epilim, Neurontin, Lamictal, Trileptal, Lyrica, Topamax,

United States

Age: Adults (18 and over)
Side Effects: Suicide Risk, Suicide Attempts, Suicide,
Summary: The FDA put out a warning to healthcare professionals about the risk of suicidal thoughts and behavior with antiepileptic drugs, used for mood-stabilizing
purposes. The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the drug and continued through 24 weeks.
Source: "Suicidality and Antiepileptic Drugs," FDA Alert, January 31, 2008.

Drug Warning, September 01, 2007
Drug Class: Antipsychotic,
Generic Name: Haloperidol,
Brand Name: Haldol,

United States

Age: Adults (18 and over)
Side Effects: Death, Sudden Death, Heart Problems, Cardiac Events,
Summary: The FDA warned healthcare professionals that, "Due to a number of case reports of sudden death, TdP [Torsades de Pointes] and QT prolongation [Tdp and QT
prolongation are types of heart abnormalities] in patients treated with haloperidol (especially when the drug is given intravenously or at doses higher than recommended),
the sponsor has updated the labeling for haloperidol." In addition, ECG (Electrocardiogram - a graphical recording of the cardiac cycle produced by a special machine)
monitoring is recommended if haloperidol is given intravenously, even though Haloperidol is not approved for intravenous administration.
Source: "Information for Healthcare Professionals Haloperidol (marketed as Haldol, Haldol Decanoate and Haldol Lactate)," FDA, September 2007.

Drug Study, May 25, 2007
Drug Class: Antidepressant,
Generic Name: Venlafaxine,
Brand Name: Effexor,

United States

Age: Adults (18 and over)
Side Effects: Suicide Risk, Suicide Attempts, Suicide ,
Summary: Psychiatric Times published an article about a study of newer antidepressants appearing in the bloodstream of "unnatural" deaths recorded by the Virginia
Medical Examiner's Office between 1987 through 2003. The study, by Dr. Antony Fernandez and colleagues, found that antidepressants were discovered in the blood
stream of suicide victims significantly more often than in accident or murder victims. The analysis also showed that among the suicides, newer antidepressants appeared
in equal proportion among those who died from poisoning, guns or hanging. MedPage Today notes that the study was published as an abstract and has not yet been
published in a peer-reviewed publication.
Source: Neil Osterweil, "APA: SSRIs More Likely in Suicides Then in Other Young Deaths," Psychiatric times, 25 May, 2007.

Drug Warning, May 02, 2007

United States

Drug Warning, May 02, 2007
United States
Drug Class: Antidepressant,
Generic Name: Clomipramine, Amoxapine, Nortriptyline, Citalopram, Duloxetine, Trazodone, Amitriptyline, Venlafaxine, Selegiline, Perphenazine and Amitriptyline,
Fluvoxamine, Escitalopram, Chlordiazepoxide and Amitriptyline, Maprotiline, Isocarboxazid, Phenelzine, Nefazodone, Desipramine, Nortriptyline, Tranylcypromine,
Paroxetine, Fluoxetine, Mirtazapine, Quetiapine, Doxepin, Trimipramine, Fluoxetine and Olanzapine, Imipramine, Protriptyline, Bupropion, Sertraline,
Brand Name: Anafranil, Asendin, Aventyl, Celexa, Cymbalta, Desyrel, Elavil, Effexor, Emsam, Etrafon, Lexapro, Limbitrol, Ludiomil, Marplan, Nardil, Norpramin, Pamelor,
Parnate, Paxil, Seroxat, Pexeva, Prozac, Remeron, Sarafem, Seroquel, Sinequan, Surmontil, Symbyax, Tofranil, Tofranil-Pm, Triavil, Vivactil, Wellbutrin, Zoloft, Zyban,
Pertofrane,
Age: Adults (18 and over)
Side Effects: Suicide Risk, Suicide Attempts, Suicide,
Summary: The FDA officially extended the age group covered in the October 15, 2004 black box warning regarding antidepressants causing suicidal tendencies, to include
18 to 24 year-olds.
Source: "FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications," FDA News, May 2, 2007.

Drug Warning, May 01, 2007
Drug Class: Antipsychotic,
Generic Name: Haloperidol,
Brand Name: Haldol,

United States

Age: Adults (18 and over)
Side Effects: Heart Problems, Cardiac Events, Death, Sudden Death,
Summary: U.S. FDA's MedWatch updated the warnings and adverse reactions for Haldol, on the extreme cardiovascular effects that Haldol injection can cause including
observations of QT-prolongation [a heart abnormality]. "Cases of sudden and unexpected death have been reported in association with the administration of Haldol."
Source: "Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 2007" FDA MedWatch, May 2007.

Drug Warning, May 01, 2007
Drug Class: Antipsychotic,
Generic Name: Ziprasidone,
Brand Name: Geodon,

United States

Age: Adults (18 and over)
Side Effects: Death, Sudden Death, Mania, Psychosis, Heart Problems, Cardiac Events, Nervous System Disorders,
Summary: The FDA issued a Safety Labeling Change for Geodon Capsules and Injection, stating that they had QT Prolongation (a heart abnormality) and risk of sudden
deat. Also details on Allergic reactions, Nervous System Disorders, Reproductive System, and breast disorders were added onto the label under "Adverse Reactions."
Source: Food and Drug Administration (FDA), "Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)", MedWatch,
May 2007.

Drug Warning, May 01, 2007
Drug Class: Stimulant,
Generic Name: Methamphetamine,
Brand Name: Desoxyn,

United States

Age: Children (under 18)
Side Effects: Death, Sudden Death, Stunted Growth, Convulsions, Seizures, Muscle Spasms, Mania, Psychosis, Heart Problems, Cardiac Events, Hallucinations,
Delusional Thinking, Sensory Disturbances, Nervous System Disorders,
Summary: The FDA's MedWatch system published a warning on the psychostimulant Desoxyn stating that the drug could cause: Sudden Death with Pre-existing Structural
Cardiac Abnormalities or other Serious Heart Problems, Psychiatric Adverse Events, Long-Term Suppression of Growth, Seizures, Visual Disturbance, as well as serious
cardiovascular adverse event.
Source: Food and Drug Administration (FDA), "Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)", MedWatch,
May 2007.

Drug Warning, August 21, 2006
Drug Class: Stimulant,
Generic Name: Dextroamphetamine,
Brand Name: Dexedrine,

United States

Age: Children (under 18)
Side Effects: Death, Sudden Death,
Summary: The FDA ordered a "boxed warning" for the psychostimulant Dexedrine, that it could cause sudden death in normal doses prescribed to children with heart
problems.
Source: "2006 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary Supplements", MedWatch, August 21, 2006.

Drug Study, August 01, 2006
Drug Class: Antidepressant,
Generic Name: Paroxetine , Sertraline, Fluoxetine,
Brand Name: Paxil, Seroxat, Zoloft, Prozac,

United States

Age: Children (under 18)
Side Effects: Suicide risk, Suicide Attempts, Suicide,
Summary: The Archives of General Psychiatry published a study which found that children taking newer antidepressants were 1.52 times more likely to attempt suicide
and 15 times more likely to succeed in the attempt than those not taking the drugs.
Source: Mark Olfson, MD, MPH, et al., "Antidepressant Drug Therapy and Suicide in Severely Depressed Children and Adults," The Archives of General Psychiatry, Vol. 63,
August 2006.

Drug Warning, May 12, 2006
Drug Class: Antidepressant,
Generic Name: Paroxetine,

United States

Generic Name: Paroxetine,
Brand Name: Paxil, Seroxat,
Age: Adults (18 and over)
Side Effects: Suicide Risk, Suicide Attempts, Suicide,
Summary: GlaxoSmithKline and the U.S. FDA warned doctors that the antidepressant Paxil increases the risk of suicide in young adults.
Source: "Paxil (paroxetine hydrochloride) Tablets and Oral Suspension" FDA MedWatch, May 12, 2006.

Drug Warning, May 09, 2006
Drug Class: Antidepressant,
Generic Name: Paroxetine,
Brand Name: Paxil, Seroxat,

United States

Age: Adults (18 and over)
Side Effects: Suicide Risk, Suicide Attempts, Suicide,
Summary: GlaxoSmithKline issued a change to the Clinical Worsening and Suicide Risk section of the drug literature for Paxil and Paxil CR. GlaxoSmithKline's research
showed a higher frequency of suicidal behavior in adults ages 18-24 taking the drug. 2.19% of people showed suicidal behavior who were taking the drug versus only
.92% in people taking a placebo.
Source: John E. Kraus, "Important Prescribing Information," GlaxoSmithKline, May 9, 2006.

Drug Study, March 07, 2006
Drug Class: Antidepressant,
Generic Name:
Brand Name:

United States

Age: Children (under 18)
Side Effects: Suicide Risk, Suicide Attempts, Suicide,
Summary: The Archives of General Psychiatry published a report by the FDA that led to the black box warnings on the antidepressants showing they could double the risk
of suicidal thoughts and actions in children who took them.
Source: "Antidepressants linked to suicide risk in youth," Boston Globe, March 7, 2006.

Drug Warning, February 09, 2006
Drug Class: Stimulant,
Generic Name: Methylphenidate, Amphetamine and Dextroamphetamine,
Brand Name: Ritalin, Adderall, Concerta,

United States

Age: Children (under 18)
Side Effects: Heart Problems, Cardiac Events, Stroke, Cerebrovascular Events, Death, Sudden Death,
Summary: The FDA's Drug Safety and Risk Management Advisory Committee urged that the strongest "black box" warning be issued for ADHD stimulants, including
Ritalin, Adderall and Concerta because of the risk of heart attacks, strokes and sudden deaths. Dr. Steven Nissen, a cardiologist and member of the advisory committee
called this a "potential public health crisis." The FDA said it had received reports of about 25 deaths linked to the drugs and a larger number of cases involving serious
consequences, such as heart attacks.
Source: "Warning Urged for ADHD Drugs" LATimes.com, February 10, 2006.

Drug Warning, November 01, 2005
Drug Class: Antidepressant,
Generic Name: Venlafaxine,
Brand Name: Effexor,

United States

Age: Adults (18 and over)
Side Effects: Homicidal Ideation,
Summary: The FDA's Safety Information and Adverse Event Reporting Program reported "homicidal ideation" as an adverse event of Effexor ER (extended release).
Source: "Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- November 2005," FDA MedWatch, November 2005.

Drug Warning, September 29, 2005
Drug Class: Antidepressant,
Generic Name: Atomoxetine,
Brand Name: Strattera,

United States

Age: Children (under 18)
Side Effects: Suicide Risk, Suicide Attempts, Suicide,
Summary: The FDA issued a Public Health Advisory entitled, "Suicidal Thinking in Children and Adolescents Being Treated with Strattera (Atomoxetine)." The FDA
directed Eli Lilly to revise the labeling of Strattera to include both a boxed warning and additional warning statements that alerted health care providers to an increased
risk of suicidal thinking in children and adolescents being treated with the drug.
Source: "Suicidal Thinking in Children and Adolescents Being Treated with Strattera (Atomoxetine)" Center for Drug Evaluation and Research September 2005.

Drug Warning, June 30, 2005
Drug Class: Antidepressant,
Generic Name: Citalopram, Venlafaxine, Fluvoxamine, Escitalopram, Paroxetine, Fluoxetine, Mirtazapine, Quetiapine,
Brand Name: Celexa, Effexor, Luvox, Lexapro, Paxil, Seroxat, Prozac, Remeron, Sarafem, Seroquel,

United States

Age: Adults (18 and over)
Side Effects: Suicide Risk, Suicide Attempts, Suicide,
Summary: The FDA issued a Public Health Advisory entitled "Suicidality in Adults Being Treated with Antidepressant Medications," that stated that several recent scientific
publications suggested the possibility of an increased risk of suicidal behavior in adults taking both older and newer antidepressants. It recommended that physicians
monitor adults who took antidepressants for suicidal tendencies.
Source: "Suicidality in Adults Being Treated with Antidepressant Medications," FDA Public Health Advisory, June 30, 2004.

Source: "Suicidality in Adults Being Treated with Antidepressant Medications," FDA Public Health Advisory, June 30, 2004.

Drug Warning, June 30, 2005
Drug Class: Antidepressant,
Generic Name: Duloxetine,
Brand Name: Cymbalta,

United States

Age: Children (under 18)
Side Effects: Suicide Risk, Suicide Attempts, Suicide,
Summary: The FDA issued an "Alert for Healthcare Professionals" about the antidepressant Cymbalta, concluding that suicidal thinking or behavior may increase in
pediatric patients treated with any type of antidepressant, especially early in treatment.
Source: Food and Drug Administration (FDA) "Duloxetine hydrochloride (marketed as Cymbalta) Information" Center for Drug Evaluation and Research June 30, 2005.

Drug Study, September 01, 2004
Drug Class: Antidepressant,
Generic Name:
Brand Name:

United States

Age: Adults (18 and over)
Side Effects: Aggression, Violence, Hostility, Mania, Psychosis,
Summary: A study in the journal Pediatrics revealed that 33% of the patients they studied that were exposed to Atomoxetine (Strattera) exhibited extreme irritability,
aggression, mania or hypomania [mild-mania].
Source: Theodore A. Henderson, M.D., Ph.D. and Keith Hotman, M.D., "Aggression, Mania, and Hypomania Induction Associated with Atomoxetine," Pediatrics, Vol. 114,
No. 3, September 2004.

Drug Study, August 20, 2004
Drug Class: Antidepressant,
Generic Name: Sertraline, Citalopram, Venlafaxine, Bupropion, Paroxetine, Fluoxetine, Fluvoxamine, Nefazodone, Mirtazapine,
Brand Name: Zoloft, Celexa, Effexor, Wellbutrin, Zyban, Luvox, Serzone, Remeron,

United States

Age: Children (under 18)
Side Effects: Suicide Risk, Suicide Attempts, Suicide,
Summary: A Columbia University review of the pediatric clinical trials of Sertraline, Citalopram, Venlafaxine, Bupropion, Paroxetine, Fluoxetine, Fluvoxamine, Nefazodone
and Mirtazapine found that young people who took them could experience suicidal thoughts or actions. Dr. Tarek Hammand of the FDA's Division of
Neuropharmacological Drug Products performed an analysis based on the Columbia University review, and stated that his analysis also "...indicates a statistically
significant association of suicidal events with antidepressant drug treatment in short-term pediatric clinical trials for all indications."
Source: Office of Drug Safety, "Follow-up Consult of August 16, 2004 by Andrew Mosholder on Suicidality in pediatric clinical trials with paroxetine and other
antidepressant drugs...," August 16, 2004.

Drug Warning, August 01, 2004
Drug Class: Stimulant,
Generic Name: Amphetamine and Dextroamphetamine, Atomoxetine, Pemoline, Methylphenidate,
Brand Name: Adderall, Adderall XR, Strattera, Ritalin, Cylert,

United States

Age: Children (under 18)
Side Effects: Heart Problems, Cardiac Events, Death, Sudden Death,
Summary: The FDA reviewed post-marketing adverse cardiovascular (heart) reactions for all stimulants and relabeled Adderall to carry a warning about sudden
cardiovascular deaths, especially in children with underlying heart disease.
Source: "Follow up review of AERS search identifying cases of sudden death occurring with drugs used for the treatment of Attention Deficit Hyperactivity Disorder
(ADHD)," FDA Advisory Committee, February 28, 2006.

Drug Study, July 21, 2004
Drug Class: Antidepressant,
Generic Name: Amitriptyline, Fluoxetine, Paroxetine,
Brand Name: Elavil, Endep, Vanatrip, Prozac, Paxil, Seroxat,

United States

Age: Children (under 18), Adults (18 and over)
Side Effects: Suicide Risk, Suicide Attempts, Suicide,
Summary: The Journal of the American Medical Association published a study that found there was a significantly higher risk of suicide and suicidal thoughts during the
first 9 days of treatment with antidepressants and that children who were first starting treatment were 4 times more likely to think about suicide, and 38 times more likely
to commit suicide and that children as young as 5 had committed suicide while taking these drugs.
Source: Hershel Jick, MD, et al., "Antidepressants and the Risk of Suicidal Behaviors," Journal of the American Medical Association, Vol. 292, No. 3, July 21, 2004.

Drug Warning, March 22, 2004
Drug Class: Antidepressant,
Generic Name: Mirtazapine, Fluoxetine, Sertraline, Paroxetine, Fluvoxamine, Citalopram, Escitalopram, Bupropion, Venlafaxine, Nefazodone,
Brand Name: Prozac, Paxil, Seroxat, Zoloft, Luvox, Celexa, Lexapro, Wellbutrin, Effexor, Serzone, Remeron,

United States

Age: Adults (18 and over)
Side Effects: Suicide Risk, Suicide Attempts, Suicide, Anxiety, Panic Attacks,
Summary: The FDA asked drug companies to add new warnings on 10 widely used antidepressants. It said patients who used Prozac (fluoxetine), Zoloft (sertraline), Paxil
(paroxetine), Luvox (fluvoxamine), Celexa (citalopram), Lexapro (escitalopram), Wellbutrin (bupropion), Effexor (venlafaxine), Serzone (nefazodone), and Remeron
(mirtazapine) should be closely monitored for possible suicidal behavior and anxiety, especially when the patient first begins taking the drugs or changes doses.
Source: "Worsening Depression and Suicidality in Patients Being Treated with Antidepressant Medications," US Food and Drug Administration Public Health Advisory,
March 22, 2004.

Drug Warning, March 22, 2004

United States

Drug Warning, March 22, 2004
Drug Class: Antidepressant,
Generic Name: Fluoxetine, Sertraline, Paroxetine, Fluvoxamine, Citalopram, Escitalopram Oxalate, Bupropion, Venlafaxine, Mirtazapine, Nefazodone,
Brand Name: Prozac, Zoloft, Paxil, Seroxat, Luvox, Celexa, Lexapro, Wellbutrin, Effexor, Serzone, Remeron,

United States

Age: Adults (18 and over), Children (under 18)
Side Effects: Anxiety, Panic Attacks, Insomnia, Disturbed Sleep, Agitation, Irritability, Aggression, Violence, Hostility, Impulsivity, Akathisia, Mania, Psychosis,
Summary: The FDA issued a Public Health Advisory, stating: "Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia [severe restlessness],
hypomania [abnormal excitement, mild mania] and mania [psychosis characterized by exalted feelings, delusions of grandeur and overproduction of ideas], have been
reported in adult and pediatric patients being treated with antidepressants."
Source: "WORSENING DEPRESSION AND SUICIDALITY IN PATIENTS BEING TREATED WITH ANTIDEPRESSANT MEDICATIONS," FDA Public Health Advisory, 22 Mar.
2004.

Drug Study, January 26, 2004
Drug Class: Antidepressant,
Generic Name: Sertraline, Paroxetine, Fluoxetine, Citalopram, Bupropion, Venlafaxine,
Brand Name: Zoloft, Paxil, Seroxat, Prozac, Celexa, Wellbutrin, Effexor,

United States

Age: Children (under 18), Adults (18 and over)
Side Effects: Suicide Risk, Suicide Attempts, Suicide, Aggression, Violence, Hostility,
Summary: Drug Safety Research issued a special report on newer antidepressants that concluded, "The higher than expected numbers of suicidal and aggressive
behaviors observed in some clinical trials of antidepressants in children also can be seen in spontaneous adverse event data, and add substantial additional evidence to
the case. The data show that suicidal/aggressive behaviors are reported in both adults and children, but more than twice as often in children. Finally, while two drugs now
carry warnings about this risk, similar risks were reported for the four drugs without warnings."
Source: Thomas J. Moore, "Antidepressant Drugs and Suicidal/Aggressive Behaviors," Drug Safety Research - Special Report, Washington, D.C., January 26, 2004.

Drug Warning, January 15, 2004
Drug Class: Antipsychotic,
Generic Name: Olanzapine,
Brand Name: Zyprexa,

United States

Age: Adults (18 and over)
Side Effects: Stroke, Cerebrovascular Events, Death, Sudden Death,
Summary: Eli Lilly & Co. sent a letter to U.S. doctors on January 15, 2004 to warn of increased risks of death and stroke when elderly patients with dementia were
prescribed Zyprexa.
Source: "Safety data on Zyprexa (olanzapine) and Symbyax™ (Olanzapine and fluoxetine HCL): Elderly Patients with Dementia-Related Psychosis," Eli Lilly, January 15,
2004.

Drug Warning, October 27, 2003
Drug Class: Antidepressant,
Generic Name: Citalopram, Fluoxetine, Fluvoxamine, Mirtazapine, Nefazodone, Paroxetine, Sertraline, Venlafaxine,
Brand Name: Celexa, Prozac, Luvox, Remeron, Serzone, Paxil, Seroxat, Zoloft, Effexor,

United States

Age: Children (under 18)
Side Effects: Suicide Risk, Suicide Attempts, Suicide,
Summary: The FDA released a "Health Advisory" where they announced that they had completed a preliminary review of reports of suicidality in pediatric patients for 8
antidepressant drugs (both newer and older antidepressants) and had determined that additional data and analysis and public discussion of available data were needed
on the issue. The Health Advisory simply urged health care professionals to use the drugs with caution.
Source: Food and Drug Administration (FDA), "Reports of Suicidality in Pediatric Patients Being Treated with Antidepressant Medications for Major Depressive Disorder
(MDD)" October 27, 2003.

Drug Warning, June 19, 2003
Drug Class: Antidepressant,
Generic Name: Paroxetine,
Brand Name: Paxil, Seroxat,

United States

Age: Children (under 18)
Side Effects: Suicide Risk, Suicide Attempts, Suicide,
Summary: The U.S. FDA issued a statement that it was reviewing reports of increased risk of suicidal thinking and suicide attempts in children and adolescents using
Paxil. The FDA noted that following the review of the same data, the UK department of health issued a press release saying that Paxil must not be used to treat depression
in children and adolescents under the age of 18.
Source: "FDA Statement Regarding the Anti-Depressant Paxil for Pediatric Population," U.S. Food and Drug Administration, FDA Talk Paper, June 19, 2003.

Drug Study, May 01, 2003
Drug Class: Antidepressant,
Generic Name: Paroxetine,
Brand Name: Paxil, Seroxat,

United States

Age: Children (under 18)
Side Effects: Suicide Risk, Suicide Attempts, Suicide,
Summary: GlaxoSmithKline submitted a report to the FDA which showed that children given Paxil (paroxetine) were more likely to become suicidal than those given
placebos. It also showed that the drug did not improve their depression any better then placebo.
Source: Gardiner Harris, "Antidepressant Study Seen to Back Expert," The New York Times, August 20, 2004.

Drug Study, July 01, 1997
Drug Class: Antidepressant,
Generic Name: Fluoxetine,
Brand Name: Prozac,

United States

Brand Name: Prozac,
Age: Adults (18 and over)
Side Effects: Aggression, Violence, Hostility, Suicide Risk, Suicide Attempts, Suicide,
Summary: In a Journal of Clinical Psychiatry study, Dr. John Zajecka reported that discontinuation [withdrawal] symptoms after treatment with Prozac can cause
"aggressiveness and suicidal impulsivity."
Source: J. Zajecka, K. Tracy, and S. Mitchell, "Discontinuation Symptoms After Treatment with Selective Serotonin Reuptake Inhibitors: A Literature Review," Journal of
Clinical Psychiatry, Vol. 58, July 1997.

Drug Warning, October 01, 1995
Drug Class: Stimulant,
Generic Name: Methylphenidate,
Brand Name: Ritalin,

United States

Age: Children (under 18)
Side Effects: Mania, Psychosis, Aggression, Violence, Hostility,
Summary: The U.S. Drug Enforcement Administration (DEA) said Ritalin use could lead to addiction and that "psychotic episodes, violent behavior and bizarre
mannerisms had been reported" with its abuse.
Source: "Methylphenidate," U.S. Drug Enforcement Administration (DEA), October 1995.

Drug Study, January 28, 1995
Drug Class: Antidepressant,
Generic Name: Fluoxetine,
Brand Name: Prozac,

United States

Age: Adults (18 and over)
Side Effects: Suicide Risk , Suicide Attempts, Suicide,
Summary: In a study in British Medical Journal entitled "Antidepressants and Suicide" one of the authors stated, "The results indicate that only fluoxetine [Prozac] has a
rate [of suicide] that seems to be substantially higher than that of other antidepressants."
Source: Susan S. Jick, Alan D. Dean and Hershel Jick, "Antidepressants and Suicide," British Medical Journal, Vol. 310, Jan. 28, 1995.

Drug Study, December 01, 1991
Drug Class: Antidepressant,
Generic Name: Fluoxetine,
Brand Name: Prozac,

United States

Age: Adults (18 and over)
Side Effects: Akathisia, Suicide Risk , Suicide Attempts, Suicide,
Summary: The Journal of Clinical Psychiatry published a study which stated, "Three depressed inpatients, 25-47 years of age, were re-exposed to fluoxetine after having
previously made a serious suicide attempt while taking the drug. This is the first report, to our knowledge, of patients restarted on fluoxetine after a previous suicide
attempt during fluoxetine treatment.... We observed that all three patients developed severe akathisia [severe restlessness] while taking fluoxetine, and they stated that the
development of this syndrome, in the context of their depressive episode, is what precipitated their prior suicide attempts. When re-exposed to fluoxetine, the patients
again developed akathisia and suicidal ideation. The suicidal feelings abated when the akathisia was treated by the discontinuation of the fluoxetine...."
Source: Anthony J. Rothschild, M.D., and Carol A. Locke, M.D., "Reexposure to Fluoxetine After Serious Suicide Attempts by Three Patients: The Role of Akathisia,"
Journal of Clinical Psychiatry, December 1991.

Drug Study, March 01, 1991
Drug Class: Antidepressant,
Generic Name: Fluoxetine,
Brand Name: Prozac,

United States

Age: Children (under 18)
Side Effects: Suicide Risk, Suicide Attempts, Suicide,
Summary: The Journal of the American Academy of Child and Adolescent Psychiatry published a study on three boys and three girls, age 10 to 17 years old, who
"developed intense self-injurious ideation or behavior while receiving fluoxetine for treatment of obsessive-compulsive disorder.... Three patients made suicide gestures
or attempts, one of which involved a massive overdose of fluoxetine. Three patients manifested persistent, driven self-injurious behavior and/or ideation that required
restraints, seclusion, or one-on-one nursing care. Suicidal ideation or self-injurious behavior persisted up to one month after the fluoxetine was discontinued."
Source: Robert King, M.D., et al., "Emergency of Self-Destructive Phenomena in Children and Adolescents during Fluoxetine Treatment," Journal of the American
Academy of Child and Adolescent Psychiatry, March 1991.

Drug Study, February 07, 1991
Drug Class: Antidepressant,
Generic Name: Fluoxetine,
Brand Name: Prozac,

United States

Age: Adults (18 and over)
Side Effects: Suicide Risk , Suicide Attempts, Suicide,
Summary: It was reported in The New England Journal of Medicine that there is a strong association in patients whom have suicidal ideation and are on fluoxetine
treatment. They reported on a 58-year-old man who "was started on fluoxetine (20 mg/day). Three days later he had violent suicidal thoughts and tried to hang himself with
a rope. The fluoxetine was discontinued, with a complete disappearance of suicidal ideation four days later."
Source: Prakash Marsand, M.D., et al., "Suicidal Ideation Related to Fluoxetine Treatment," The New England Journal of Medicine, February 7, 1991.

Drug Study, February 01, 1990
Drug Class: Antidepressant,
Generic Name: Fluoxetine,
Brand Name: Prozac,
Age: Adults (18 and over), Children (under 18)

United States

Age: Adults (18 and over), Children (under 18)
Side Effects: Suicide Risk , Suicide Attempts, Suicide,
Summary: Harvard doctors Martin Teicher and Jonathan Cole reported in the American Journal of Psychiatry that six of their patients had developed "intense, violent
suicidal" thoughts soon after starting Prozac. One patient reported feeling like "jumping out of her skin." So great was her "anxiety, fear, and turbulence that she felt
'death would be a welcome result." Another patient "became violent, banging her head and mutilating herself...."
Source: Martin Teicher, M.D. and Jonathan Cole, M.D., "Emergence of Intense Suicidal Preoccupation During Fluoxetine Treatment" American Journal of Psychiatry, Vol.
147, Is. 2, February 1990.

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