As you know...this is Denis Losier who protested against the hospital cuts in the North Shore. Denis and his brother died last week in a tragic accident!!!! My deepest sympathy to his family!!!
Monday, July 04, 2005
FDA ALERT ON VIOLENCE- AND SUICIDE-INDUCING STIMULANTS
Anyone who has experienced the side effects listed below (or others) should email Citizens Commission on Human Rights P.S.!!! THIS HAS NOTHING TO DO WITH THOSE RACIST MEMBERS OF THE NEW BRUNSWICK HUMAN RIGHTS COMMISSION!!!!
humanrights@cchr.org
FDA ALERT ON VIOLENCE- AND SUICIDE-INDUCING STIMULANTS
June 28, 2005: The Food and Drug Administration says that “ADHD” stimulants cause visual hallucinations, aggression, violent and suicidal behavior….
Since the 1980s, Citizens Commission on Human Rights has exposed the dangers of stimulants such as Ritalin prescribed for the psychiatric invention, Attention Deficit Hyperactivity Disorder (ADHD). For years psychiatry has promoted the notion of a “chemical imbalance” to prescribe psychiatric drugs to over eight million schoolchildren - a $1 billion dollar a year industry - despite the fact that no medical or scientific test has ever validated psychiatry’s theories about chemical imbalances. Medical experts say there is no evidence that ADHD exists as a physical, neurobiological disease and that prescribing cocaine-like stimulants for something that cannot be physically diagnosed is child abuse.
On June 28, 2005, The FDA finally ordered labeling changes to methylphenidate [Ritalin] products, including Concerta to warn that these drugs can cause “psychiatric events.” These are described as “visual hallucinations, suicidal ideation, psychotic behavior, as well as aggression or violent behavior.
Bruce Wiseman, president of CCHR in the U.S., says, “Parents have been denied information on these dangerous suicide and violence-inducing drug side effects for years, unwittingly placing their children at risk. The public awareness raised in the media recently about these and other psychiatric drugs and Congressional Hearings into why such information has been withheld, may finally mean that parents will be able to make truly informed decisions about protecting their children's health, instead of being further victimized by psychiatry's smoke-and-mirrors history of fraud and deceit."
Breaking News
FDA Eyes Pyschiatric Risks of ADHD Drugs
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON -(Dow Jones)- The Food and Drug Administration said it intends to make labeling changes for a certain class of drugs used to treat attention deficit hyperactivity disorder over concerns about psychiatric events associated with the drugs.
The FDA said it would make labeling changes to Johnson & Johnson's (JNJ) Concerta and other methylphenidate products describing psychiatric events "such as visual hallucinations, suicidal ideation, psychotic behavior, as well as aggression or violent behavior." The drugs are used to treat ADHD in adults and children. Other drugs in the category include Novartis AG's (NVS) Ritalin, which is also available as a generic.
The FDA made the statement Tuesday as part of background material posted to its Web site ahead of a pediatric advisory committee meeting Wednesday and Thursday.
An FDA spokeswoman declined to discuss the number of psychiatric adverse event reports it has received related to Concerta and similar drugs, saying the data would be presented to the pediatric panel on Thursday.
A Johnson & Johnson spokeswoman wasn't immediately available to comment on Concerta. ADHD is a disorder in which people have attention, or inattention, problems that cause impairment in academic, work or social settings. People with ADHD are often hyperactive and impulsive. ADD is a similar disorder without the hyperactive behavior that is often associated with adults more than children.
The panel of outside medical experts will be discussing adverse event reports in children for several drugs including Concerta. The reports are mandated by law for drugs approved specifically for use in children and are discussed before the pediatric panel on a periodic basis.
"In addition we believe it is critical to examine the other stimulant products approved for ADHD...to determine if they too are associated with these adverse events," the FDA said in its statement. The agency also said it would look at atomoxetine, a nonstimulant product sold under the brand name Strattera by Eli Lilly and Co. (LLY).
The agency said it was currently reviewing adverse event reports for so-called amphetamine products like Shire Pharmaceuticals PLC's (SHPGY) Adderall as well as for Strattera and hoped to bring the review to the pediatric panel in early 2006.
Meanwhile, the FDA is seeking the panel's advice on what information it should provide to the public about the ADHD drugs that are widely used in children while it's collecting information on the number of types of psychiatric events possibly associated with ADHD drugs along with possible cardiovascular risks.
The agency is concerned with possible cardiovascular events in people using the drugs. Earlier this year Health Canada ordered Adderall off the market after reports of sudden death in 20 patients, including 12 reports of stroke.
Last year the FDA required Shire to update Adderall's label in the U.S. to warn that it should not be used in children or adults with structural cardiac abnormalities.
The FDA said it's too soon to tell if ADHD drugs really increase cardiovascular risk and that it was "pursuing additional means to better characterize the cardiovascular risks for all drug products approved for ADHD." Among the options, the FDA said, was long-term safety trials to look at cardiovascular risks.
- By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com.
(END) Dow Jones Newswires
06-28-05 1405ET
Copyright (c) 2005 Dow Jones & Company, Inc.
Breaking News Archive
humanrights@cchr.org
FDA ALERT ON VIOLENCE- AND SUICIDE-INDUCING STIMULANTS
June 28, 2005: The Food and Drug Administration says that “ADHD” stimulants cause visual hallucinations, aggression, violent and suicidal behavior….
Since the 1980s, Citizens Commission on Human Rights has exposed the dangers of stimulants such as Ritalin prescribed for the psychiatric invention, Attention Deficit Hyperactivity Disorder (ADHD). For years psychiatry has promoted the notion of a “chemical imbalance” to prescribe psychiatric drugs to over eight million schoolchildren - a $1 billion dollar a year industry - despite the fact that no medical or scientific test has ever validated psychiatry’s theories about chemical imbalances. Medical experts say there is no evidence that ADHD exists as a physical, neurobiological disease and that prescribing cocaine-like stimulants for something that cannot be physically diagnosed is child abuse.
On June 28, 2005, The FDA finally ordered labeling changes to methylphenidate [Ritalin] products, including Concerta to warn that these drugs can cause “psychiatric events.” These are described as “visual hallucinations, suicidal ideation, psychotic behavior, as well as aggression or violent behavior.
Bruce Wiseman, president of CCHR in the U.S., says, “Parents have been denied information on these dangerous suicide and violence-inducing drug side effects for years, unwittingly placing their children at risk. The public awareness raised in the media recently about these and other psychiatric drugs and Congressional Hearings into why such information has been withheld, may finally mean that parents will be able to make truly informed decisions about protecting their children's health, instead of being further victimized by psychiatry's smoke-and-mirrors history of fraud and deceit."
Breaking News
FDA Eyes Pyschiatric Risks of ADHD Drugs
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON -(Dow Jones)- The Food and Drug Administration said it intends to make labeling changes for a certain class of drugs used to treat attention deficit hyperactivity disorder over concerns about psychiatric events associated with the drugs.
The FDA said it would make labeling changes to Johnson & Johnson's (JNJ) Concerta and other methylphenidate products describing psychiatric events "such as visual hallucinations, suicidal ideation, psychotic behavior, as well as aggression or violent behavior." The drugs are used to treat ADHD in adults and children. Other drugs in the category include Novartis AG's (NVS) Ritalin, which is also available as a generic.
The FDA made the statement Tuesday as part of background material posted to its Web site ahead of a pediatric advisory committee meeting Wednesday and Thursday.
An FDA spokeswoman declined to discuss the number of psychiatric adverse event reports it has received related to Concerta and similar drugs, saying the data would be presented to the pediatric panel on Thursday.
A Johnson & Johnson spokeswoman wasn't immediately available to comment on Concerta. ADHD is a disorder in which people have attention, or inattention, problems that cause impairment in academic, work or social settings. People with ADHD are often hyperactive and impulsive. ADD is a similar disorder without the hyperactive behavior that is often associated with adults more than children.
The panel of outside medical experts will be discussing adverse event reports in children for several drugs including Concerta. The reports are mandated by law for drugs approved specifically for use in children and are discussed before the pediatric panel on a periodic basis.
"In addition we believe it is critical to examine the other stimulant products approved for ADHD...to determine if they too are associated with these adverse events," the FDA said in its statement. The agency also said it would look at atomoxetine, a nonstimulant product sold under the brand name Strattera by Eli Lilly and Co. (LLY).
The agency said it was currently reviewing adverse event reports for so-called amphetamine products like Shire Pharmaceuticals PLC's (SHPGY) Adderall as well as for Strattera and hoped to bring the review to the pediatric panel in early 2006.
Meanwhile, the FDA is seeking the panel's advice on what information it should provide to the public about the ADHD drugs that are widely used in children while it's collecting information on the number of types of psychiatric events possibly associated with ADHD drugs along with possible cardiovascular risks.
The agency is concerned with possible cardiovascular events in people using the drugs. Earlier this year Health Canada ordered Adderall off the market after reports of sudden death in 20 patients, including 12 reports of stroke.
Last year the FDA required Shire to update Adderall's label in the U.S. to warn that it should not be used in children or adults with structural cardiac abnormalities.
The FDA said it's too soon to tell if ADHD drugs really increase cardiovascular risk and that it was "pursuing additional means to better characterize the cardiovascular risks for all drug products approved for ADHD." Among the options, the FDA said, was long-term safety trials to look at cardiovascular risks.
- By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com.
(END) Dow Jones Newswires
06-28-05 1405ET
Copyright (c) 2005 Dow Jones & Company, Inc.
Breaking News Archive
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