7 Year Old's Tragic Death Exposes Over-Prescription of Psychotropic Drugs

http://www.eagleforum.org/educate/2009/may09/tragic-death.html The suicide of a seven-year-old boy last month in Broward county, Florida raises again the issue of overmedication and dangerous mis-medication of young children. Gabriel Myers was a foster care child who had been prescribed four different psychotropic drugs. Only one of the drugs was officially approved for use in children, and two of the drugs carried the Food and Drug Administration "black box" warning label that warns doctors of an increased risk for suicide in children and teens who take the drugs.

In 2005, following a series of Miami Herald stories on the over-prescription of psychotropic drugs to foster care children, the Florida legislature passed a law attempting to address the problem of overmedication. Four times a year, the state Agency for Health Care Administration (AHCA) now evaluates how Florida doctors prescribe psychiatric drugs to children who are on Medicaid. AHCA looks for the doctors who most frequently prescribe psychiatric drugs, or who prescribe potentially dangerous combinations of drugs. Of the 17,000 doctors in the state who prescribe for children on Medicaid, AHCA flags between 300 and 450 each quarter. AHCA has flagged Gabriel Myers's psychiatrist, Dr. Sohail Punjwani, each quarter since the program's inception in 2006.

Gabriel was one of the millions of American children taking prescription drugs that are not officially approved for pediatric use, through doctors' practice of "off-label" prescribing. Once the FDA approves a drug for one age group or type of treatment, doctors can and often do prescribe it "off-label" for other groups or conditions. 6.7% of American children take at least one psychotropic drug, and three-quarters of the time their drug use is off-label.

Gabriel took Vyvanse, an ADHD drug that is FDA-approved for children ages 6 through 12. But he was also prescribed Lexapro and Zyprexa, an antidepressant and antipsychotic, respectively, that are not approved for children. A few weeks before his death, Gabriel's doctor took him off of Lexapro and Zyprexa and placed him on Symbyax, a combination drug that contains the main ingredient in the antipsychotic Zyprexa together with fluoxetine, another antidepressant. Fluoxetine is the active ingredient in Prozac, and is also not approved for pediatric use. Like Lexapro, fluoxetine is in the category of antidepressants that the FDA warned in 2003 were linked to increased "suicidal thoughts or behaviors" in children, compared to children who are similarly depressed but don't take such medications.

According to Gabriel's uncle, the boy's grandfather spoke to him two weeks before his death and said he sounded like he was "doped up" and "too drugged." When Gabriel lived with relatives for a short period of time, his pediatrician discontinued his psychotropic drugs, and according to his uncle, Gabriel did well and earned A's and B's at the private Christian school he attended.

In an interview with the Miami Herald, Dr. Punjwani defended the pediatric use of drugs like those Gabriel Myers received, saying that the only reason they aren't approved for children is that pharmaceutical companies are unwilling to perform clinical trials on children. He pointed out that off-label pediatric use of such drugs to treat mood instability and insomnia is routine for many doctors, and widely accepted as safe.

Dr. David L. Katz, a Yale University professor of public health, disagreed, calling pediatric use of such drugs "extremely risky." According to Katz, drugs like these might be appropriate for a child who had been diagnosed with schizophrenia, but were questionable for others. "These are medications that are potent and potentially dangerous," said Katz. "They certainly are powerful drugs for anybody, let alone a seven-year-old boy." (Miami Herald, 4-21-09)