[snip]

It's been publicly revealed that Harris had been prescribed and was taking Luvox (Fluvoxamine maleate), a powerful antidepressant, at the time of the shooting spree. Although Klebold's medical records have been sealed, there is strong reason to believe that he too had been prescribed one of several popular drugs for depression. Throughout the 1990s these drugs arguably became the standard response to a wide variety of behavioral problems in schools, especially for boys. An alleged side-effect of these drugs is a loss of empathy for other human beings. Of the various USA "school shooters" whose medical history has been made public, all were either currently taking or had recently gone off one of these powerful mind-altering prescription drugs given to them to treat various serious behavioral problems.
brainy encyclopedia

Luvox(R) (fluvoxamine maleate) Tablets is the first SSRI to gain clearance from the U.S. Food and Drug Administration (FDA) to treat Obsessive Compulsive Disorder (OCD) in children and adolescents.

As the first selective serotonin reuptake inhibitor (SSRI) for this indication, Luvox Tablets offers new hope for the estimated one million children and adolescents who have OCD. The product is jointly marketed by Solvay Pharmaceuticals Inc. and Pharmacia & Upjohn Inc. - source

RX List

A 10-week, randomized, double-blind, placebo-controlled, multi-center study of LUVOX Tablets involving 120 children ranging in age from 8 to 17 years showed that fluvoxamine is more effective than placebo for the treatment of OCD. LUVOX Tablets was also well-tolerated; only three children taking fluvoxamine dropped out of the study due to adverse effects, none of which were considered serious.

Side Effects

Most commonly observed side effects included agitation, hyperkinesia, depression, dysmenorrhea, flatulence and rash. centerwatch

Eric Harris was taking Luvox (a Prozac-like drug) at the time of the Littleton murders by Peter R. Breggin, M.D.

On April 29 the Washington Post confirmed that Eric Harris, the leader in the Littleton tragedy, was taking the psychiatric drug Luvox at the time of the murders. On April 30 the same newspaper published a story quoting expert claims that Luvox is safe and has no association with causing violence. In fact, Luvox and closely related drugs commonly produce manic psychoses, aggression, and other behavioral abnormalities in children and young people.

Luvox is a Selective Serotonin Reuptake Inhibitor (SSRI) that is approved for children and youth (up to age 17) for use in the treatment of obsessive compulsive disorder. However, doctors often give it for depression, since it is in the same SSRI class as Prozac, Zoloft, and Paxil.

According to the manufacturer, Solvay, 4% of children and youth taking Luvox developed mania during short-term controlled clinical trials. Mania is a psychosis which can produce bizarre, grandiose, highly elaborated destructive plans, including mass murder. Interestingly, in a recent controlled clinical trial, Prozac produced mania in the same age group at a rate of 6%. These are very high rates for drug-induced mania--much higher than those produced in adults. Yet the risk will be even higher during long-term clinical use where medical supervision, as in the case of Harris, is much more lax than in controlled clinical trials. These drugs also produce irritability, aggression or hostility, alienation, agitation, and loss of empathy.

Reports suggest that Eric Harris may have had a relatively good family life. If so, it adds to the probability that he was suffering from a drug-induced manic reaction caused by Luvox. The phenomenon of drug-induced manic reactions caused by antidepressants is so widely recognized that it is discussed several times in the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association and many times in The Physicians' Desk Reference.

I have lectured widely and written extensively about violence in association with taking SSRI antidepressants in Talking Back to Prozac (St. Martin's Press, 1994) and Brain-Disabling Treatments in Psychiatry (Springer Publishing Company, 1997). I have testified as a medical expert in three teenage cases of murder in which SSRIs were implicated in playing a role. In one case, a sixteen year old committed murder and tried to set off multiple bombs and incendiary devices at the same time. I have also testified in cases of adult murderers who were under the influence of SSRIs, including one mass murder of twelve people followed by suicide. The comparisons to Littleton are obvious.

Psychiatric drugs including Ritalin and Prozac have also been taken by at least one other school murderer (Kip Kinkle). Psychiatric drug use is only one of the contributing factors to the episodes of school violence. However, it is one of the most easily prevented factors. There is strong scientific evidence to support the view that SSRIs should not be given to children and teenagers. - source

Families of five Columbine High School shooting victims are suing the maker of an anti-depressant that one of the student gunmen was taking when he opened fire.

A therapeutic amount of the drug Luvox was found in Eric Harris' system after he died, the Jefferson County coroner's office has said.

Solvay Pharmaceuticals Inc. makes the drug to treat obsessive-compulsive disorder and depression. The lawsuit filed Friday in U.S. District Court claims Solvay failed to warn Harris' doctor about side effects.

"Such drugs caused Eric Harris to become manic and psychotic," the lawsuit states. - CBS

The second lawsuit was filed against the killers' parents by the families of five students who died at Columbine - Danny Rohrbough, Kelly Fleming, Matt Kechter, Lauren Townsend and Kyle Velasquez. - rocky mountain news

Insight Magazine reporter, Kelly Patricia O'Meara, reports in (below) that 19- year old Mark Taylor, a victim of the shooting spree at Columbine high school in 1999, spent nearly two months in the hospital plus 3 years of follow-up operations. Taylor is suing the drug company, Solvay Pharmaceuticals, manufacturers of Luvox, an antidepressant drug whose adverse side-effects include manic and psychotic reactions.

See: http://www.drugawareness.org

A consultant in Taylor's lawsuit, Dr. Ann Blake Tracy, heads the International Coalition for Drug Awareness, she says: "Suing Solvay for the injuries Mark Taylor suffered is one of the biggest SSRI suits we'll ever see," Tracy says. "It's a pivotal case because what happened at Columbine was so big. It's really crazy when you think about it. All you have to do is read the Luvox package insert to see that Eric's actions were due to an adverse reaction to this drug. Show me a drug anywhere that has listed mania and psychosis as frequent adverse reactions. That is what the insert says for Luvox. There is no doubt in my mind that Luvox caused Eric Harris to commit these acts." - source

more

Marietta, Ga. (Feb. 6, 2003) - Solvay Pharmaceuticals, Inc. announced today that Mark Taylor has agreed to dismiss his lawsuit against Solvay Pharmaceuticals, Inc. in relation to the Columbine tragedy.

The joint statement released by the court on behalf of both parties is as follows:

"Mr. Taylor has agreed to dismiss his lawsuit against Solvay Pharmaceuticals, Inc. No money has been or will be paid to Mr. Taylor or his lawyers in exchange for this dismissal. Solvay will make a charitable donation in the amount of $10,000 to the American Cancer Society. The resolution and dismissal of this case is in no way a reflection of the merits or the claims made by Mr. Taylor or the defenses raised by Solvay. Mr. Taylor believes his claims had merit, but Solvay has always denied, and continues to deny, each of Mr. Taylor's claims about LUVOX. Both parties are pleased with the amicable resolution and dismissal of this case without the need of subjecting the Denver community and the victims of Columbine to a public trial of this case." - source

destroyed testimony?

A special room under strict lock-and-key, filled with evidence from two settled Columbine cases, is being shut down and a federal magistrate has ordered some of the materials - including depositions of the killers' parents - destroyed. The room, in the federal courthouse in downtown Denver, was set aside in 2002 to "house particular documents and materials deemed to be worthy of special handling and security," according to court documents. - source

RECALLING FIRM/MANUFACTURER

Recalling Firm: Solvay Pharmaceuticals, Inc., Marietta, GA, by letter on May 29, 2002. Manufacturer: Solvay Pharmaceuticals, Inc., Baudette, MN.Firm initiated recall is ongoing.

REASON

Inaccuracies in data submitted to the New Drug Application by Solvay (stability). - source

re branding?

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of the new drug applications (NDAs) for ROWASA (mesalamine) Rectal Suppositories, 500 milligrams (mg), and LUVOX (fluvoxamine maleate) 25- mg, 50-mg, 100-mg, and 150-mg tablets, held by Solvay Pharmaceuticals, Inc., 901 Sawyer Rd., Marietta, GA 30062. Solvay has voluntarily withdrawn these NDAs in response to audit findings indicating possible inaccuracies noted in the chemistry, manufacturing, and controls (CMC) section of the applications. Solvay has agreed to permit FDA to withdraw approval of the applications, thereby waiving its opportunity for a hearing. In addition, FDA has determined that LUVOX (fluvoxamine maleate) 25-mg, 50-mg, 100-mg, and 150-mg tablets was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to continue to approve abbreviated new drug applications (ANDAs) for fluvoxamine maleate 25-mg, 50-mg, 100-mg, and 150-mg tablets.

In the course of an audit, FDA discovered inaccuracies in the CMC section of the LUVOX (fluvoxamine maleate) application.

Although these findings raised concerns about the drug product as manufactured by Solvay, they do not affect the safety or efficacy of fluvoxamine maleate in treating obsessive compulsive disorder. source

May 2004 - Subject: Stronger WARNING for SSRIs and other newer anti-depressants regarding the potential for behavioural and emotional changes, including risk of self-harm

Solvay Pharma Inc, following discussions with Health Canada, would like to inform you of important safety information regarding the possibility that SSRIs (selective serotonin reuptake inhibitors) and other newer anti-depressants may be associated with behavioural and emotional changes, including risk of self-harm

POTENTIAL ASSOCIATION WITH THE OCCURRENCE OF BEHAVIOURAL AND EMOTIONAL CHANGES, INCLUDING SELF-HARM.

Pediatrics: Placebo-Controlled Clinical Trial Data

Recent analyses of placebo-controlled clinical trial safety databases from SSRIs and other newer anti-depressants suggest that use of these drugs in patients under the age of 18 may be associated with behavioural and emotional changes, including an increased risk of suicidal ideation and behaviour over that of placebo.

The small denominators in the clinical trial database, as well as the variability in placebo rates, preclude reliable conclusions on the relative safety profiles among these drugs. Adult and Pediatrics: Additional data

There are clinical trial and post-marketing reports with SSRIs and other newer anti-depressants, in both pediatrics and adults, of severe agitation-type adverse events coupled with self-harm or harm to others. The agitation-type events include: akathisia, agitation, disinhibition, emotional lability, hostility, aggression, depersonalization. In some cases, the events occurred within several weeks of starting treatment.

Rigorous clinical monitoring for suicidal ideation or other indicators of potential for suicidal behaviour is advised in patients of all ages. This includes monitoring for agitation-type emotional and behavioural changes.

Discontinuation Symptoms Patients currently taking fluvoxamine should NOT be discontinued abruptly, due to risk of discontinuation symptoms. At the time that a medical decision is made to discontinue an SSRI or other newer anti-depressant drug, a gradual reduction in the dose rather than an abrupt cessation is recommended. - source

After reading the above - watch 'Brain Candy'

It'll make a lot more sense...

Scientist Chris Cooper (Kevin McDonald) discovers the cure for depression ("it "chemically" locates your happiest memory, and then "chemically" locks onto that emotion and freezes it chemically"), a orange pill called Gleemonex. Without doing enough testing, they put the drug on the market. Soon, just about everyone's addicted to it. Cooper later finds out that early test subjects have slipped into comas.

Documents: Prozac use reports more likely to list suicide

Internal documents from Eli Lilly and Co. appear to indicate that the drug maker had data more than 15 years ago showing that adverse-effect reports for Prozac were far more likely to list suicide attempts and violence than reports for other antidepressants.

One memo suggests a strategy for talking to doctors about unfavorable clinical trial data showing an increased risk of nervousness, anxiety, agitation, insomnia and sedation among patients.

Lilly officials said Tuesday numbers in the documents made public Monday represented not clinical trials but "adverse effects" reported to the U.S. Food and Drug Administration. The company acknowledged the documents belong to Lilly.

The data were reviewed extensively at the time, said Dr. Charles Beasley of Lilly, but "we did not believe this data, for a number of reasons, were terribly useful or informative in terms of suggesting anything about a causal link between the drug and the adverse effects being reported."

The documents were provided to CNN by the office of Rep. Maurice Hinchey, D-New York, who has called for tightening FDA regulations on drug safety.

"The case demonstrates the need for Congress to mandate the complete disclosure of all clinical studies for FDA-approved drugs so that patients and their doctors, not the drug companies, decide whether the benefits of taking a certain medicine outweigh the risks," he said.

One of the documents cites what a Lilly official told CNN were 14,198 adverse-effect reports in which 3.7 percent were suicide attempts by people on fluoxetine -- the generic name for Prozac. That rate was far higher than those cited for any of four other commonly used antidepressants.

The document also states that 2.3 percent of those adverse-effect reports concerned psychotic depression while on the drug, more than double the next-highest rate of patients using any of the other antidepressants. In addition, the document said that 1.6 percent were reported incidents of hostility -- more than double the rate reported on any of the other commonly used antidepressants.

And, the document says, 0.8 percent of adverse-effect reports concerned patients causing an intentional injury -- eight times the rate associated with any of the other antidepressants.

Lilly officials said Prozac had only recently been approved in the United States at the time those data were compiled and as a result the drug was under close scrutiny by physicians, receiving more adverse effect reports than the older antidepressants. Such reports would be expected to decrease the longer any drug remains on the market, Beasley said.

Among the documents is a memo in which the author says the drug may produce nervousness, anxiety, agitation or insomnia in 19 percent of patients, and sedation in 13 percent of patients.

Beasley did not dispute the contents and said he likely authored the memo, titled "Activation and sedation in fluoxetine clinical trials."

The memo said, "Several suggestions may be helpful in presenting this information to physicians," including emphasizing that more patients on another class of antidepressants stopped taking their drugs than did those on Prozac.

The existence of the documents obtained by CNN and other documents was reported last week by the British Medical Journal. Its editors said the documents had been reported missing from a 10-year-old murder case, and that they had sent them to the FDA for review.

The journal said the documents disappeared in 1994, during the case of Joseph Wesbecker, a printing press operator who had killed eight people at his Louisville, Kentucky, workplace five years before, while taking fluoxetine. He then shot and killed himself.

Each of the four pages of the documents obtained by CNN is stamped "Confidential" and "Fentress," the name of one of Wesbecker's victims.

That stamp, said Lilly spokesman Morry Smulevitz, likely was used because the documents were provided to plaintiffs' attorneys in the trial. He said the documents did not disappear, but have always been available.

In a civil suit against Eli Lilly, victims' relatives contended the company had long known about the side effects of fluoxetine, including its alleged role in increasing a user's propensity to violence.

Lilly initially won the case, but it was later forced to admit that it had made a secret settlement with the plaintiffs during the trial, which meant that the verdict was invalid, the journal said.

The FDA has recently warned that antidepressants can cause side effects such as agitation, panic attacks, insomnia, and aggressiveness.

In a statement posted on Lilly's Web site, the company said, "To our knowledge, there has never been any allegation of missing documents from the Wesbecker trial or any other trial involving Lilly. Further, it has always been Lilly's objective to publicly disclose data about both the safety and efficacy of fluoxetine.

"Lilly has made several requests to the BMJ to obtain copies of the supposed 'missing' documents; we still await these documents. We are surprised and concerned that a leading medical journal would not find it important to share these documents with us so that we could respond to the public in a meaningful way."

Based on its history of having provided regulatory authorities with study results, the statement said, "Lilly believes that there is no new scientific information to review on this topic."

About 54 million people worldwide have taken Prozac, Smulevitz said - CNN

Prozac truth

link to Eli lilly documents