Go to http://www.cchrint.org/psychdrugdangers to also see international studies as well as adverse reactions reported to the US FDA’s Medwatch.  Also see the recent study from PLoS One here on psychiatric drugs being linked to violence.

There have been 22 international drug regulatory warnings issued on psychiatric drugs causing violence, mania, hostility, aggression, psychosis, and other violent type reactions.  These warnings have been issued in the United States, European Union, Japan, United Kingdom, Australia and Canada.

July 01, 2009
United States

The FDA has required the manufacturers of the smoking cessation aids varenicline (Chantix) and bupropion (Zyban, aka Wellbutrin) to add new Boxed Warnings and develop patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms in patients using these products. 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.

May 2009
Japan

The Japanese Ministry of Health, Labor and Welfare investigated news reports of antidepressant users “who developed increased feelings of hostility or anxiety, and have even committed sudden acts of violence against others.” After its investigation, the Ministry decided to revise the label warnings on newer antidepressants stating, “There are cases where we cannot rule out a causal relationship [of hostility, anxiety, and sudden acts of violence] with the medication.”

Source: “Japan Revises SSRI Warnings–Hostility, Violence,” Medical News Today, May 28, 2009.

March 2009
United Kingdom

Medicines and Healthcare products Regulatory Agency (UK) published in their Drug Safety Update newsletter new information about Atomoxetine (Strattera, a non-stimulant ADHD drug). They warned that Atomoxetine is associated with treatment-emergent psychotic or manic symptoms in children without a history of such disorders.

Source: Medicines and Healthcare products Regulatory Agency, Drug Safety Update newsletter, Vol. 2, March 8, 2009.

February 2009
Australia

The Australian Therapeutic Goods Administration reported that a boxed warning (the strongest warning) was placed onto the ADHD psychostimulant drug methylphenidate (Concerta and Ritalin) for drug dependence. It warns that chronic abuse of methylphenidate can lead to a marked tolerance and psychological dependence with varying degrees of abnormal behavior and frank psychotic episodes can also occur.

Source: “Boxed Warning, Contraindications and strengthened Precautions for Methylphenidate,” Janssen-Cilag, February 2009.

December 2008
Australia

The Australian Adverse Drug Reactions Bulletin published an article about the psychostimulant Modafinil. The bulletin advised that this drug has been reported to cause serious adverse skin and psychiatric reactions including anxiety, hallucination, aggression, and mania.

Source: Adverse Drug Reactions Advisory Committee, Australian Adverse Drug Reactions Bulletin, Vol. 27, No. 6, December 2008.

November 20, 2008
European Union

Eli Lilly included in their Strattera label in Europe warnings that Strattera causes “hallucinations, delusional thinking, mania or agitation in children and adolescents without a prior history of psychotic illness or mania…” Strattera is an antidepressant prescribed as a “non stimulant” drug to treat ADHD.

Source: “Official warnings issued: The ADHD drug Strattera CAUSES psychosis, hallucinations, mania and agitation” TransWorldNews, November 20, 2008.

September 2007
United States

The Vice President of Medical Services at the drug company Cephalon sent out a letter to health care professionals informing them of new warnings for the company’s psychostimulant Provigil. “Updated Safety Information: Warnings regarding serious rash, including Stevens Johnson Syndrome [a life-threatening condition affecting the skin] and hypersensitivity reactions, and psychiatric symptoms (including anxiety, mania, hallucinations, and suicidal ideation). 1. Provigil can cause life-threatening skin and other serious hypersensitivity reactions… 2. Provigil is not approved for use in pediatric patients for any indication. 3. Provigil can cause psychiatric symptoms.”

Source: Jeffrey M. Dayno, M.D., “Dear Healthcare Professional,” Cephalon, September 2007.

May 2007
United States

The FDA’s MedWatch system published a warning on the psychostimulant Desoxyn which is used for ADHD 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.

February 21, 2007
United States

The FDA directed ADHD drug manufacturers to distribute “patient friendly” guides to consumers warning about serious psychiatric and cardiovascular problems, including stroke, heart attack, sudden death and psychotic reactions caused by ADHD drugs.   The psychiatric adverse events included hearing voices, becoming suspicious for no reason, or becoming manic, even in patients who did not have previous psychiatric problems.

Source: “FDA Directs ADHD Drug Manufacturers to Notify Patients about Cardiovascular Adverse Events and Psychiatric Adverse Events,” FDA News, February 21, 2007.

August 21, 2006
United States

The FDA said that ADHD stimulant manufacturers have to strengthen their warning labels to warn that the drugs can cause suppression of growth, psychosis, bipolar illness, aggression, and ‘serious’ cardiovascular side effects, including misuse possibly leading to sudden death from heart attacks and strokes. Psychostimulant drug companies GlaxoSmithKline and Shire posted a letter to doctors about the revised prescribing information.

Source: “UPDATE 2-US FDA calls for new warnings on ADHD drugs”, Reuters, August 21, 2006.

February 2006
Canada

Health Canada approved a new warning label for Paxil that read, in part: “A small number of patients taking drugs of this type may feel worse instead of better. For example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts, such as thoughts of self-harm or harm to others.”  Health Canada required Paxil’s product information to detail a list of “rare” side effects, affecting fewer than one in 1,000 patients. These include delusions, hostility, psychosis, and psychotic depression.

Source: Kate Jaimet, “’I've learned a lesson in the worst way possible’: What drove a loving father to kill his son?,” Ottawa Citizen, 27 Aug. 2006.

November 2005
United States

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.

August 19, 2005
European Union

The Commission of the European Communities, representing 25 European countries, endorsed and issued the strongest warning yet against child antidepressant use as recommended by Europe’s Committee for Medicinal Products for Human Use (CHMP). Clinical trials had shown that the drugs caused suicidal behavior including suicide attempts and suicidal ideation, aggression, hostility (predominantly aggression, oppositional behavior and anger) and/or related behavior.

Source: Commission of the European Communities Commission Decision concerning the placement on the market, under Article 21 of the Directive 2001/83/EC of the European Parliament and of the Council, Brussels 19-VIII-2005, C (2205) 3256.

June 28, 2005
United States

The FDA announced its intention to make labeling changes for Concerta and other methylphenidate (Ritalin) products (stimulants) to include, “psychiatric events such as visual hallucinations, suicidal ideation [ideas], psychotic behavior, as well as aggression or violent behavior.” The FDA announced its intention to also investigate possible cardiac concerns with these drugs.

Source: “Statement on Concerta and Methylphenidate for the June 30 PAC”, Food and Drug Administration (FDA), June 2005.

April 25, 2005
European Union

The European Medicines Agency’s scientific committee, the Committee for Medicinal Products for Human Use, concluded that Prozac-type antidepressants were associated with increased suicide-related behavior and hostility in young people. The London-based watchdog said it recommended the inclusion of strong warnings across the whole of the European Union to doctors and parents about these risks and that the drugs should not be used in children and adolescents in off label situations.

Source: “EU calls for tougher warnings on antidepressants for kids” News-Medical.net April 25, 2005.

December 2004
Australia

The Australian Therapeutic Goods Administration published an Adverse Drug Reactions Bulletin recommending that any use of SSRIs in children and adolescents should be carefully monitored for the emergence of suicidal ideation.  In a recent study involving Prozac, it said, there was an increase in adverse psychiatric events of suicide, self-harm, aggression and violence.

Source: “Use of antidepressants in children and adolescents,” The Australian Therapeutic Goods Administration (TGA) published an Adverse Drug Reactions Bulletin, Vol 23, No. 6, Dec. 2004, p. 22.

September 21, 2004
United Kingdom

The British Healthcare Products Regulatory Authority advised that it had issued guidelines that children should not be given most SSRI antidepressants because of clinical trial data showing an increase rate of harmful outcomes, including hostility.

Source: “Antidepressant aggression concern,” BBC News, 21 Sept. 2004.

June 03, 2004
Canada

Health Canada issued an advisory to the public that stated that stronger warnings have been placed on antidepressants. These warnings indicate that people taking these drugs at any age are at greater risk of behavioral or emotional changes including self-harm or harm to others. The advisory said, “A small number of patients taking drugs of this type may feel worse instead of better…. For example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts that could involve self-harm or harm to others.”

Source: Jirina Vlk, “Health Canada advises Canadians of stronger warnings for SSRIs and other newer anti-depressants,” Health Canada, 2004-31, June 3, 2004.

April 22, 2004
European Union

The European Agency for the Evaluation of Medicinal Products issued a press release to the press and public. In this press release, they reported that, according to clinical trials, Paroxetine containing medicines could cause suicidal behavior and hostility in children. It recommended that Paroxetine not be used in children and recommended that young adults be observed carefully for signs and symptoms of suicidal behavior or hostility. Paroxetine was shown to have little effectiveness in children according to clinical trials. The committee also recommended strengthened warnings on the withdrawal symptoms of paroxetine, which are common.

Source: “European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products 20-22 April 2004″ EMEA, The European Agency for the Evaluation of Medicinal Products, Press Release April 2004.

March 22, 2004
United States

The FDA Public Health Advisory was issued, 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.

August 22, 2003
Canada

Wyeth Pharmaceuticals, the makers of the antidepressant Effexor, issued a warning to U.S. and Canadian doctors that use of this drug could cause hostility, suicidal ideation and self-harm in patients under the age of 18.

Source: Wyeth Pharmaceuticals, “Dear Health Care Professional…” Health Canada, Health Products and Food Branch, August 22, 2003.

October 1995
United States

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.