Europe's Medicine Agency Tightens Noose on Antidepressant Prescriptions for Kids

The European Commission confirming the recommendation of the Europe’s Committee for Medicinal Products for Human Use (CHMP) has just issued the strongest warnings against child antidepressant use to date following a review of clinical trials that showed the drugs cause “suicidal behavior, including suicide attempts and suicidal ideation and/or related behavior like self-harm, hostility (predominantly aggression, oppositional behavior and anger) and mood lability [instability] in children and adolescents.” Due to the drugs dangerous side effects, the agency said they should not be prescribed to any under 18-year-old.

Worldwide sales of antidepressants reached more than $19.5 billion in 2002, but evidence continues to mount that clinical trial data was withheld from drug regulatory agencies such as the U.S. Food and Drug Administration (FDA) during the approval process.

An estimated 17 million children worldwide are prescribed some form of psychotropic (mind-altering) drug, with 8 million of these in the United States. Up to 2 million American children are prescribed the drugs condemned by the CHMP: Paxil, Effexor, Prozac, Luvox, Celexa, Lexapro, Zoloft, Remeron, and Strattera, another type of antidepressant, prescribed for “Attention Deficit Hyperactivity Disorder,” a diagnosis plagued by controversy because there is no physical means to test for or diagnose it.

Two other drugs cited by CHMP, Milnacipran (Mildalcipran, Ixel) and Reboxetine (Edronax, Vestra) have not been approved for use in the U.S.

Since 1991, the Citizens Commission on Human Rights, a psychiatric watchdog group, and independent doctors and researchers have raised the alarm about many of these drugs causing suicide and violent behavior. Nine out of 13 school shooters in the United States were taking antidepressants or “ADHD” stimulants known to cause aggressive behavior. In October, the FDA finally ordered that a black box label be added to antidepressant information warning that the drugs cause suicide in children and adolescents.

Ms. Jan Eastgate, international president of CCHR, said that the warnings need to go further: “These drugs are being approved for use in the treatment of wholly fabricated ‘disorders’ that psychiatrists are using to hook millions of kids on dangerous drugs. In the wake of the FDA warnings, the American Psychiatric Association president Steven Sharfstein finally admitted that there is no lab test to determine that a chemical imbalance exists for which these drugs are prescribed. If psychiatrists had their way—and based on their own statistics—over 107 million kids would be on psychiatric drugs worldwide. These warnings—which in Europe will encompass 25 countries—may stem the tide of drugging innocent children, but the drugs should never have been approved for pediatric use in the first place. “

However, the last 18 months have seen increased warnings about the dangers of the drugs.

On March 24, 2004 a FDA Public Health Advisory warned about antidepressants causing agitation, panic attacks, irritability, hostility, and mania. Five months later, an FDA official, Dr. Andrew D. Mosholder, reviewed 22 studies, which showed that children were nearly twice as likely to become suicidal taking antidepressants than those given placebos. On October 15, the FDA ordered the “black box” warning for antidepressants.

In June this year, the FDA announced its intention to order labeling changes for stimulants such as Concerta, Ritalin and other “ADHD” drugs to warn that they can cause “visual hallucinations, suicidal ideation, psychotic behavior, as well as aggression or violent behavior.” It also issued a Public Health Advisory about the potential increased risk of suicide in adults taking antidepressants.

Last December, the FDA ordered additional warnings on Strattera, because of its potential to cause liver damage.

On 17 December, the European Commission requested the CHMP review the marketing for antidepressants and whether this should be amended. CHMP concluded that additional warnings were necessary as suicidal and aggressive behaviors were more frequently observed in clinical trials among children and adolescents compared to those taking placebo.

“These are potentially killer drugs and they should never be prescribed to children,” said Ms. Eastgate. “The studies are coming up with this fact over and over again.” CCHR, which was established by the Church of Scientology in 1969 to investigate and expose psychiatric abuses, was instrumental in obtaining an FDA hearing into antidepressants in 1991. However, a panel of mainly psychiatrists and a psychologist advising the FDA gave the drugs a clean bill of health. Since then hundreds of children have attempted or committed suicide while under the influence of these drugs. “The blood of these children is caked on psychiatry’s hands,” said Eastgate.

Published: August 31, 2005
Author: Marla Filidei