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After months of investigation and an emotional public hearing, the FDA is responding to evidence that use of antidepressant medications prescribed to children actually raises their risk of suicide. The agency said in a recent statement it was working on new warning labels for all antidepressants to explain these risks.

What may further alarm parents, however, is that of the 10 drugs involved in this investigation only three are FDA-approved for use in children: Prozac, Zoloft and Luvox.

That means most antidepressants prescribed for children are prescribed for off-label use. Off-label use refers to the use of a drug for any purpose other than what is described in the medication's official insert. Off-label uses, which are not regulated by the FDA, may include treatment of unapproved diseases, unapproved dosages and for unapproved populations such as children. The American Medical Association has estimated that as many as 40 percent of all prescriptions are issued for off-label use.

So how are off-label uses discovered?

Turns out that researchers (especially pharmaceutical researchers) continually conduct studies to determine new uses for already marketed drugs in a clear effort to increase profits. The results of these studies are most often published in peer-reviewed medical journals, which some allege are ghost-written by pharmaceutical companies themselves. Doctors then begin prescribing the drugs for these "advertised" uses.

Of course, off-label drug use may cause harm because all drugs have side effects. According to a report published by the pharmacy industry magazine, Drug Topics, over 200,000 people a year die from adverse reactions to drugs, compared to only 41,000 who die in auto accidents each year. Similarly alarming numbers are reported by the Journal of the American Medical Association and the National Academies.

These frightening stats aside, off-label prescriptions of antidepressants to children have been dramatically on the rise in the last 10 years. Reportedly, "the use of Prozac among children from ages 6-12 went from 41,000 in 1995 to 203,000 in 1996." This kind of use has made antidepressants some of the biggest moneymakers ever for the pharmaceutical companies.

In response to this trend, at least one researcher, Dr. Ann Blake Tracy, head of the International Coalition for Drug Awareness and author of "Prozac: Panacea or Pandora," has been warning the American public against the deceit of industry's stakeholders in legally prescribed drugs.

She claims the public has been duped by a "highly organized, extremely well-financed promotional apparatus concerning the use of antidepressants." She claims "fake science has been passed off as evidence-based treatment strategies; selective, partial data have been manipulated to show positive results; physicians and parents have been deceived – and children were put in harm's way, exposed to potentially lethal drugs that have not demonstrated an effect greater than placebo."

Corroborating claims of drug-industry deception, "a two-year Los Angeles Times investigation published in December 2000 found that the seven drugs approved since 1993 have been withdrawn after reports of deaths and severe side effects. In the article written by Times Staff Writer David Willam, it states, 'The FDA approved each of those drugs while disregarding danger signs or blunt warnings from its own specialists. Then, after receiving reports of significant harm to patients, the agency was slow to seek withdrawals.'"

This raises questions of whether the government and medical community have been duped along with the American public by these high tech drug pushers, or whether they are in cahoots.

Worse news concerning antidepressant drugs is their almost undeniable link to rampant acts of violence. Some of the more high-profile incidents include the shootings at Columbine, the Phil Hartman murder/suicide, the Texas mother Andrea Yates who killed her five children, the Atlanta day-trader shooting and countless others. Many of the families and victims of these so-called antidepressant "side effects" testified at the public hearing held by the FDA advisory panel two weeks ago.

The FDA response for now is to place an increased warning on the labels of these drugs. Until more is done, everyone should think about the drugs they are taking. Are they approved for their prescribed use, or off-label? And how much do you really know about the possible side effects?