Action is also needed to protect the safety of their school mates who are also at risk of drug-induced violence.
• This committee should recommend:
a Risk Minimization Action Plan for ALL classes of drugs that trigger psychosis / violence—Stimulants, antidepressants and antipsychotics.
Rationale: All of these drugs are being prescribed for ADHD, and they all trigger dangerous violent behavior. Furthermore, many millions of children are affected by FDA-approved prescribed psychotropic drugs.
Black Box warnings are NOT enough to reduce the risk to the public health
Rationale: Very few parents ever see a drug label, and few doctors are guided by a drug’s label warnings.
• AHRP believes that mandatory restrictions on access to these drugs is needed; and a mandatory registry for doctors who prescribe psychotropic drugs with an adverse effects profile that includes violence and hallucinations—as described in FDA’s current adverse event reports (AERS) review.
• A warning that polypharmacy has not been tested for safety, is therefore, experimental.
• Limit product promotion: prohibit advertising of drugs linked to violent or psychotic behavior.
Rationale: These drugs pose a danger both for children for whom they are prescribed and also for their school mates and play mates. (Also teachers, parents, etc.)
• Require physicians to provide parents with a copy of FDA-approved label & MedGuide.
Rationale: Parents are the responsible decision makers for determining what’s best for their children’s welfare. Parents should, therefore, be provided with accurate information. This recommendation was also made by the Advisory Committee in February.
• Require signed parental informed consent for psychotropic drugs that pose risks of psychotic violent behavior.
See AHRP Testimony presented by Vera Sharav and Allen Jones before FDA Pediatric Advisory Committee, ADHD drug safety, March 22, 2006:
A Drug-Induced Mental Health Crisis, (924 KB PowerPoint Presentation):
Testimony by Ellen Liversidge:
<p class="MsoNormal">Good afternoon. I am a member of the Alliance for Human Research Protection (AHRP), a parent, and a speech pathologist in an elementary school where we regularly give the Connors ADHD Rating Scale on boys, always boys, tell the parent the child tests positive for ADHD, and suggest they take the report to their pediatrician. Schools are the pipeline for ADHD diagnoses, and I recommend that the FDA, perhaps in concert with the Department of Education, must require that real risk information be provided to each parent who is given this recommendation by the authority figure that their child’s school represents. They get nothing now, by us or by their doctors.</p> <p class="MsoNormal">I reviewed the United Nations Convention on the Rights of the Child; 41 tenets ratified by every country in the World except the U.S. and Somalia, and number 33 stood out. It said “The government should protect children from dangerous drugs.” It looks as if we are not doing a good job of that so perhaps it’s just as well that we didn’t sign.. </p> <p class="MsoNormal">The Vanderbilt study, just out, showing that 2.1 million children are taking off-label atypical antipsychotics, over half of them for ADHD, is horrifying. The state of Louisiana brought suit against Eli Lilly and Janssen Pharmaceuticals for alleged unfair business practices by misleading doctors into believing these drugs were safe for children even though they are not FDA-approved. How the suit turned out, and whether more states have brought similar suits, is not known to me. But it figures that the industry would go after the third vulnerable group available – first people with mental illness, which brought an 8,000 plaintiff lawsuit for diabetes, hyperglycemia, and death -second, the elderly – an off-label use that brought a strong black box warning after multiple deaths; the second warning, placed after that for diabetes, hyperglycemia, and death - and finally children. What will the FDA do with these drugs, which carry two warnings already? Will it wait for more diabetes and deaths in children? Why isn’t this class of drugs under discussion today?</p> <p class="MsoNormal">In your packet is the harrowing story of a mother who was pressured by her sons’ schools into putting them on ADHD drugs. Over the years, they were on and off 12 psychotropics, doubled their body weight when put on Zyprexa, and suffered mightily until their parents weaned them off, which caused 18 side effects. She says ”We will always live with the realization that, as their parents, we were an instrument of delivery in the poisoning of our two little boys. I pray that your children will never be turned into mindless zombies as ours were.”</p> <p class="MsoNormal">Thank you for listening. Ms. Sharav of AHRP will include recommendations in her remarks.</p> <p><strong>Ellen Liversidge, Silver Spring, MD, email firstname.lastname@example.org</strong>