Babies given mind altering drugs in Florida / 68 Paxil Withdrawal Victims File Lawsuit

Babies given mind altering drugs in Florida / 68 Paxil Withdrawal Victims File Lawsuit

Wed, 24 Sep 2003

The serious problems that children in foster care have, are compounded by the scourge of psychotropic drugs which they are forced to take.

The Miami Herald reports that the Florida Statewide Advocacy Council (an arm of the Department of Children and Families) conducted a two-year investigation of 1,180 foster children, following the revelations of abuse made by the Herald in 2001. The Council’s report (issued earlier this month) found that more than 50% of the children –including 17 preschoolers– were on mind altering drugs that had not been approved by the FDA as safe for children. 44% of the children had not been seen by a doctor. The report notes that 59 children had no diagnosis, while another 143 children had the diagnosis described as:"other.”

It is clear that psychotropic drugs are being used as chemical restraints– a form of child abuse. Indeed, Richard Wexler, head of the Virginia-based National Coalition for Child Protection Reform called this practice ”child abuse on a grand scale. It’s obvious that [Department of Children & Families] DCF still hasn’t learned to just say no to drugs.”

Of note: In the wake of several investigative reports in the British media that revealed the hazards posed by SSRI antidepressant drugs, public outrage led GlaxoSmithKline (GSK) to issue warnings to healthcare professionals and to revise the package label of the antidepressant, Seroxat (Paxil) in the UK. The company deleted the claim, Seroxat “is non-habit forming,” and acknowledged a two to three fold increased suicide risk for children taking the drug. However, GSK has not similarly revised the US label for Paxil, nor issued a “Dear Healthcare Professional” letter to US physicians.

Of further note: Wyeth pharmaceuticals issued “Dear Doctor” letters to US physicians warning about the same serious risks for children taking their antidepressant, Effexor.

The British government began to take action to contain the over-prescribing of mind-altering drugs for children. The British Committee on Safety in Medicines (equivalent to US FDA) has issued several public warnings about severe, drug- induced adverse effects–including withdrawal symptoms and suicidal acts. See, most recent September 2003 UK document at:

On September 22, 2003 a mass rejoinder lawsuit was filed on behalf of 68 Washington State residents who claimed they have suffered severe withdrawal reactions when trying to stop taking the antidepressant, Paxil (Seroxat) in U.S. District Court in Seattle, Washington (Case No. CV 03-2886-L)against SmithKline Beecham d/b/a GlaxoSmithkline (“GSK”).

Karen A. Barth, a partner in the national law firm of Baum, Hedlund, Aristei, Guilford & Schiavo, is spearheading the Paxil withdrawal cases in the United States, since 2001 when the firm filed its first class action suit against GSK. The current complaint charges filed in federal court include intentional misrepresentation, fraud, negligence, strict liability, and express and implied warranty claims. See:


Miami Herald
Mind-altering drugs given to some babies in DCF’s care
Sept 17, 2002 p. A-1

About 650 Florida foster children, including some not under the care of a pediatrician, have been given mind-altering drugs. They represent more than half of a group examined by an advocacy agency appointed by the governor.

Infants and toddlers were being administered the drugs, most of which the U.S. Food and Drug Administration has not found to be safe or effective for children’s use, according to a report released Thursday by the Statewide Advocacy Council. The report follows a two-year study by the council.

”The use of psychotropic drugs by preschoolers was a disturbing discovery, since most of these drugs have not been approved for use in young children,” the report states.

The state Department of Children & Families disputes the validity of the research.

The drugs, developed to fight schizophrenia, major depression and bipolar disorder, can induce serious side effects, including heart problems, growth suppression, psychosis and decreased blood flow to the brain. A common side effect is the development of neurological tics, or shakes.

The advocacy council, affiliated with the DCF, launched the investigation in 2001, following extensive reporting by The Herald detailing widespread use of such drugs among children in state care.


Advocates say child-welfare administrators have not discouraged the use of mood-altering drugs as a ”chemical restraint” designed to control the behavior of difficult or unruly children.

”This is child abuse on a grand scale,” said Richard Wexler, head of the Virginia-based National Coalition for Child Protection Reform. "It’s obvious that DCF still hasn’t learned to just say no to drugs.”

The DCF, which has been reviewing the report for two months, disputed the major findings, and insisted that no broad conclusions could be drawn from the research because too few children were included in the study’s sample. The group studied 1,180 foster children out of about 15,000 in state care. More than half — 652 — were on at least one drug. Seventeen of the 652 were preschoolers.

”We have real concerns about some of their numbers,” said Celeste Putnam, the DCF’s acting deputy secretary for programs and a longtime mental health administrator. "We don’t think it’s a good idea to make generalizations from these numbers.”

The study, Putnam said, also included a preponderance of children with serious mental health and behavioral disorders — children already more likely to be prescribed medication.

”These kids already had some serious problems,” Putnam said. "These would be the kids with the most severe emotional disorders.”

But Florida’s Medicaid office, the state and federal insurance program for the needy, said it was struck by ”the number of children [who] were prescribed psychotropic medications without a psychiatric diagnosis” or a diagnosis that seemed to justify the use of such drugs.

Medicaid pays for most of foster kids’ medical needs.

”In many of the records we reviewed, there was no psychiatric diagnosis, or the diagnosis was so vague that it would be difficult to justify” the use of drugs, the report said.

Five percent of the children, or 59, had no diagnosis. Another 143 children, or 12 percent, had the diagnosis of "other.”

”Other” diagnoses included ”hearing impaired,” substance abuse, bed-wetting, adjustment disorder and "abuse.”

Researchers found one foster family in which all four foster kids were being given the same four psychiatric drugs — ”all in the sames doses,” said Bill Marvin, the advocacy council’s executive director.


Among other findings:

Thirty-eight percent of the children studied were given drugs without signed consent from a parent, guardian or judge, as state law requires. ”The files contained signed blank consent forms,” the report said. ”Some of the signed forms contained blanks [for] the pertinent and most applicable” questions.

Putnam disputed that. ”In all cases where we don’t have parental consent, we seek a court order,” she said.

The bulk of children on psychiatric drugs, or 89 percent, have no records in their file to show they are being medically monitored.

Nearly half, or 44 percent, of the children had not been evaluated by a medical doctor. Putnam disputed that.

”No physician out there will prescribe medication without giving an evaluation or examination to the child,” she said.

The advocacy counsel’s report is ”troubling,” said Andrea Moore, a Coral Springs attorney who helped spark a public outcry when she wrote a letter to DCF administrators alleging that mind-altering drugs were being used as "chemical restraints.”

”There’s nothing in this report that allays my concern that the medications are not being properly prescribed and monitored,” Moore said late Thursday. "Any parent who didn’t take their child to a doctor would be questioned for medical neglect.”

In a written response, department Secretary Jerry Regier said the department is already addressing concerns raised in the report, according to The Associated Press.

”I am committed to ensuring that the children in the department’s custody receive the finest care possible, including the prescribed use of psychotropic drugs when they are needed,” he wrote. "These medications should not be prescribed unless all other avenues of behavioral health services have been unable to meet the child’s needs.”

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