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September 29, 2005: FDA requires ADHD drug Strattera to carry a "black box" warning, the strongest required by U.S. regulators. On the same day, the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) alerts the public that they were looking into the drug's health risks following clinical trials which identified an increased risk of suicidal thoughts and behavior in children taking it. September 28, 2005: UK's National Institute of Clinical Excellence published guidelines for treating depression in people under 18 years of age, ordering doctors to stop prescribing antidepressants blamed for suicidal feelings. August 19, 2005: The Commission of the European Communities, representing 25 countries, issued its decision to issue the strongest warning yet against child antidepressant use as recommended by Europe's Committee for Medicinal Products for Human Use (CHMP). This followed a review of clinical trials that showed the drugs cause suicidal behavior including suicide attempts and suicidal ideation, aggression, hostility and/or related behavior. June 30, 2005: The FDA issued a Public Health Advisory entitled "Suicidality in Adults Being Treated with Antidepressant Medications," recommending that physicians monitor adults who take antidepressants for suicidal tendencies. June 29, 2005: The FDA announced they would make labeling changes for Concerta and other methylphenidate products used to treat ADHD to include, "psychiatric events such as visual hallucinations, suicidal ideation, psychotic behavior, as well as aggression or violent behavior." April 25, 2005: The European Medicines Agency's scientific committee, the Committee for Medicinal Products for Human Use, completed its review of two classes of antidepressants and concluded that they should not be used in children and adolescents because of suicide-related behavior and hostility observed during clinical trials of the drugs. April 11, 2005: The FDA issued a Public Health Advisory regarding the use of atypical (second generation) antipsychotic drugs in elderly patients for dementia, citing a nearly two-fold increase in death rates and calling for a boxed warning to include that such drugs were not approved for the treatment of dementia. February 9, 2005: The FDA in a Public Health Advisory and an Alert for Healthcare Professionals, announced that Health Canada suspended marketing of ADHD drug Adderall from the Canadian market due to concern about reports of sudden unexplained death in children taking the drug. December 17, 2004: The FDA required that a new warning
be added to the packaging of the ADHD drug Strattera, that it be discontinued
in patients who develop jaundice or liver damage, which "may progress
to liver failure resulting in death or the need for a liver transplant
in a small percentage of patients." August 20, 2004: The FDA announced that a Columbia University review of the pediatric clinical trials of several modern antidepressants found that young people who took them were more likely than those taking a placebo to experience suicidal thoughts or actions. April 2004: The European Agency for the Evaluation of Medicinal Products, which represents the 25 countries of the European Union, conducted a review of the psychiatric drug paroxetine (generic name for Paxil) and found its use associated with increased risk of suicidal behavior and hostility and determined that it should not be used in children and adolescents. March 24, 2004: The FDA issued a public health advisory on the use of antidepressants in both adults and children and requested the manufacturers of ten of the drugs to include a stronger cautionary warning about the emergence of suicidal ideation in all individuals taking the drugs.
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