Adverse events, including fatalities, are under-reported for children

via Archives of Internal Medicine:

Serious Adverse Drug Events Reported to the Food and Drug Administration, 1998-2005
Thomas J. Moore, AB; Michael R. Cohen, RPh, MS, ScD; Curt D. Furberg, MD, PhD
Arch Intern Med. 2007;167(16):1752-1759. doi:10.1001/archinte.167.16.1752.

an excerpt:

"A disproportionate share of adverse events occurred among elderly patients, while fewer than expected were reported among children younger than 18 years (Table 3). Children younger than 18 years accounted for 25.8% of the total US population but accounted for 7.4% of the reported serious adverse events. After adjusting for a lower likelihood of taking prescription drugs, the 7.4% of events reported in children remained lower than the 13.8% expected, based on the population size adjusted for medication use. read here

The above study seems to demonstrate that adverse events children experience due to  FDA-approved prescription drugs  are under-reported.  Indeed, the authors state, "estimates of what fraction of serious events were reported to the AERS vary between 0.3% and 33%, depending on event, period, and drug. However, the reporting requirements, definitions of serious events, and other fundamentals of the system were unchanged throughout the study period."  

This acknowledgement that a minority of adverse events are reported overall, means that the number of adverse events, including fatalities from FDA-approved drugs in children is seriously under-reported.  The number of children having adverse events including fatalities from prescription drugs is even higher than this report quantifies. We know that three of the top 15 drugs causing fatalities are neuroleptics, or antipsychotics, and one is an SSRI antidepressant, drugs which are prescribed off label to children; reporting of adverse events and fatalities due to FDA-approved drugs prescribed off label needs to become mandatory.  

The reliance on teratogenic drugs to treat vulnerable children with emotional and behavioral problems is a direct result of the illegal marketing of psychotropic drugs for off label use.  This is not ethical medical care, it is not an evidence based practice; only a Standard Practice because it was voted on by the same professionals who continue to vehemently defend their "prescribing rights,"  the psychiatrists who are members of the American Academy of Child and Adolescent Psychiatry and the American Psychiatric Association.  The cost for off label prescriptions continues to be funded by illegally billing the prescriptions to Medicaid; an ongoing crime that is  defrauding of the American people.  The drugs themselves may be helpful to some children, but that fact is not a justification for ignoring the drugs' teratogenic effects which have the potential to disable and kill the children that take them!  Why we are not tracking the number of vulnerable children who are disabled or killed by the adverse effects of FDA approved drugs prescribed to them off label? It seems unethical, despicable; morally reprehensible really.  

via 1 Boring Old Man: 

psychotropic talking points?…
Posted on Monday 17 September 2012

a few excerpts:
"Purusing the American Academy of Child and Adolescent Psychiatry web site, I clicked on Advocacy and read: AACAP partners with our members in advocacy efforts at the federal and state levels to improve policies and services for children and adolescents with mental illness. We work to educate policymakers and administrators about issues affecting child and adolescent psychiatry and children’s mental health and regularly engage our members on pertinent legislation and regulatory activities.

"… and stopped laughing. I know the print is small, but I suggest actually reading all the words. I thought advocacy would be something lofty like the plight of children and adolescents, or maybe the guild [as in the restrictions of Managed Care]. But I honestly didn’t expect Talking Points for "off label" prescribing – just like I didn’t expect Talking Points for ignoring the Black Box warning [talking points?…]. I suppose it’s possible to argue that they’re lobbying for physicians’ rights to prescribe or that the medicines are vital for children, but that would be a rationalization extraordinaire [an adolescent defense mechanism described by Anna Freud in 1936]. I’m afraid they’re lobbying for the pharmaceutical industry. (emphasis mine)

"At this point, I’d enjoy a rant eg "Who are these people? The American Academy of Child and Adolescent Psychopharmacologists?" but I’ll try to remain civil. And I’m not going to go on and on with this vetting of their web site. I think I’ve read enough. The AACAP is heavily infected with the pharmaceutical bug as far as I can see, and I find that disappointing [to say the least]. I’ve lived under the delusion that the reason they won’t retract Dr. Keller’s 2001 article about Study 329 is peculiar, maybe not wanting to hurt the feelings of the authors, or the editor. I retract that naive theory. They’re in the game. I didn’t know that, and it makes me feel kind of sad. It’s an organization I’ve looked up to in the past. I guess things change, sometimes for the worse…" read here

photo credit here