Fluvoxamine as a cause of stimulation, mania and aggression with a critical analysis

Health professionals often rely upon government approved labels for medications as a reliable source of information in determining potential adverse drug reactions. This can lead these professionals to under-estimate the hazards associated with drugs. As an illustration of the need for greater caution and skepticism, this article with examine the label for Luvox (fluvoxamine) as approved by the U.S. Food and Drug Administration (FDA). It will compare the contents of the label to the known risks of fluvoxamine-induced stimulation, mania and aggression in children and adults. The intention is to alert health professionals to the need for approaching government-approved drug labels with more scientific sophistication, especially in regard to evaluating the risks of medications. In the spring of 1997, fluvoxamine was approved in the United States for the treatment of obsessivecompulsive disorder in children (aged 8–17) and for adults. Fluvoxamine, manufactured by Solvay Pharmaceuticals, Inc., was the first Selective Serotonin Reuptake Inhibitor (SSRI) to be approved for any purpose in children. Controlled clinical trials involving children are required for a drug to be approved for use by children under the age of eighteen. The potential for fluvoxamine to cause stimulation, mania and violence became a public health issue in the United States after the student Eric Harris committed multiple murders and suicide on April 20, 1999 at Columbine High School in Littleton, Colorado (described in detail in [5]). Harris had been taking fluvoxamine for approximately one year. According to the manufacturer’s report [45] to the Food and Drug Administration (FDA), Eric Harris had a “therapeutic blood level” of fluvoxamine at the time of his autopsy. Eric Harris was born on April 9, 1981. He had recently reached the age of seventeen at the time he began to take fluvoxamine. In regard to drug testing for FDA approval, this put him one-year within in the pediatric category for FDA studies (under age 18). Eric had reached the age of eighteen just eleven days before he committed the violence on April 20, 1999. When it was revealed that Eric Harris had been