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Add to My Group(s)
Add to My Group(s)
By Evelyn Pringle (about the author)
Become a Fan -- Page 2 of 4 page(s)
Panel member, Dr Curt Furberg, recommended that ADHD drugs also come with a patient guide "so that when parents are filling prescriptions for their kids they get a written document laying out the state of knowledge, or lack of the state of knowledge and the potential risks so they are reminded each time that there is a potential risk and we are trying to find solutions to it, " he advised.
Since last month 's recommendation for a black box warning on cardiovascular events, FDA reviewers announced a recommendation for stronger warnings on all ADHD drugs due to reports of numerous adverse events like mania and psychosis in clinical trials, including modafinil.
On March 14, 2006, an FDA review was posted to the agency's web site in advance of next week's meeting. The FDA said stronger warnings are needed on the risk of psychosis, a mental disorder characterized by the inability to distinguish real and imaginary events.
"The most important finding of this review is that signs of psychosis or mania, particularly hallucinations, can occur in patients with no identifiable risk factors, at usual doses of any of the drugs used to treat ADHD," according to a memo dated March 3 from two members of the agency's ADHD psychiatric review team.
The review said current labeling neither addresses those concerns nor does it "clearly state the importance of stopping drug therapy in any patient who develops hallucinations or other signs or symptoms of psychosis or mania during drug treatment of ADHD."
From January 2000, through June 30, 2005, the review found nearly 1,000 reports of psychosis or mania possibly linked to the drugs, including Adderall, Concerta, Ritalin and Strattera. The reports were pulled from the FDA's database and from the drug makers themselves after the FDA had requested additional information from the drug companies.
The FDA found a "substantial portion of the psychosis-related cases were reported to occur in children 10 years or less," an age group which according to the FDA, does not typically suffer from psychosis.
"The predominance in young children of hallucinations, both visual and tactile, involving insects, snakes and worms is striking and deserves further evaluation," the FDA noted.
Last fall, on September 29, 2005, the FDA issued a public health advisory to alert physicians of reports of suicidal thinking in children and adolescents associated with Strattera, and directed Eli Lilly, manufacturer of Strattera, to develop a Medication Guide for patients and caregivers.
Although Strattera is marketed as a "nonstimulant" medication, according to pediatrician, Dr DuBose Ravenel, MD, FAAP, of Cornerstone Pediatrics, "it is in fact a stimulant every bit as much as the traditional stimulants, as evidenced by even a cursory consideration of its pharmacological action, and evidenced by the fact that it is classified as such by the World Health Organization. "
Dr Fred Baughman, ADHD expert and well-known author, will testify before the committee next week on behalf of the International Center for the Study of Psychiatry and Psychology.
"We know these drugs are poisons, " Dr Bughman warns, "and we know they are highly addictive, dangerous and sometimes deadly. "
He points to the senseless death of children on ADHD drugs. "Matthew Smith is dead today not because of ADHD, " he says, "but, as carefully delineated by the medical examiner, his chronic Ritalin/methylphenidate exposure. "
"Nor is there any other plausible explanation for the death of Stephanie Hall, 11 years old of Canton, OH, " he advises. "No physical predisposing factor other than Ritalin was present, " he notes, "leading up to her death, in bed, by cardiac arrhythmia. "
"The main question the FDA needs to answer concerns ADHD, " Dr Baughman says, "the "disorder" these addictive, dangerous, sometimes deadly drugs are used to treat. "
"The shocking fact of the matter is that it is not a disorder/disease at all, " he explains, "children said to have it are entirely normal meaning they bear no objective, demonstrable, diagnosable, abnormality, meaning there is no justification for prescribing these or any other drugs for so-called ADHD--a wholly fictitious, wholly subjective entity. "
Become a Fan -- Page 2 of 4 page(s)
Since last month 's recommendation for a black box warning on cardiovascular events, FDA reviewers announced a recommendation for stronger warnings on all ADHD drugs due to reports of numerous adverse events like mania and psychosis in clinical trials, including modafinil.
On March 14, 2006, an FDA review was posted to the agency's web site in advance of next week's meeting. The FDA said stronger warnings are needed on the risk of psychosis, a mental disorder characterized by the inability to distinguish real and imaginary events.
"The most important finding of this review is that signs of psychosis or mania, particularly hallucinations, can occur in patients with no identifiable risk factors, at usual doses of any of the drugs used to treat ADHD," according to a memo dated March 3 from two members of the agency's ADHD psychiatric review team.
The review said current labeling neither addresses those concerns nor does it "clearly state the importance of stopping drug therapy in any patient who develops hallucinations or other signs or symptoms of psychosis or mania during drug treatment of ADHD."
From January 2000, through June 30, 2005, the review found nearly 1,000 reports of psychosis or mania possibly linked to the drugs, including Adderall, Concerta, Ritalin and Strattera. The reports were pulled from the FDA's database and from the drug makers themselves after the FDA had requested additional information from the drug companies.
The FDA found a "substantial portion of the psychosis-related cases were reported to occur in children 10 years or less," an age group which according to the FDA, does not typically suffer from psychosis.
"The predominance in young children of hallucinations, both visual and tactile, involving insects, snakes and worms is striking and deserves further evaluation," the FDA noted.
Last fall, on September 29, 2005, the FDA issued a public health advisory to alert physicians of reports of suicidal thinking in children and adolescents associated with Strattera, and directed Eli Lilly, manufacturer of Strattera, to develop a Medication Guide for patients and caregivers.
Although Strattera is marketed as a "nonstimulant" medication, according to pediatrician, Dr DuBose Ravenel, MD, FAAP, of Cornerstone Pediatrics, "it is in fact a stimulant every bit as much as the traditional stimulants, as evidenced by even a cursory consideration of its pharmacological action, and evidenced by the fact that it is classified as such by the World Health Organization. "
Dr Fred Baughman, ADHD expert and well-known author, will testify before the committee next week on behalf of the International Center for the Study of Psychiatry and Psychology.
"We know these drugs are poisons, " Dr Bughman warns, "and we know they are highly addictive, dangerous and sometimes deadly. "
He points to the senseless death of children on ADHD drugs. "Matthew Smith is dead today not because of ADHD, " he says, "but, as carefully delineated by the medical examiner, his chronic Ritalin/methylphenidate exposure. "
"Nor is there any other plausible explanation for the death of Stephanie Hall, 11 years old of Canton, OH, " he advises. "No physical predisposing factor other than Ritalin was present, " he notes, "leading up to her death, in bed, by cardiac arrhythmia. "
"The main question the FDA needs to answer concerns ADHD, " Dr Baughman says, "the "disorder" these addictive, dangerous, sometimes deadly drugs are used to treat. "
"The shocking fact of the matter is that it is not a disorder/disease at all, " he explains, "children said to have it are entirely normal meaning they bear no objective, demonstrable, diagnosable, abnormality, meaning there is no justification for prescribing these or any other drugs for so-called ADHD--a wholly fictitious, wholly subjective entity. "
Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.
The views expressed in this article are the sole responsibility of the author
and do not necessarily reflect those of this website or its editors.
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Zyprexa caused my diabetes
by Daniel Haszard on Monday, Mar 20, 2006 at 9:11:13 AM