Earlier this year, a Massachusetts couple were charged with the murder of their 4-year-old daughter, who, according to authorities, died because of an overdose of multiple psychotropic drugs prescribed to her. While Rebecca Riley was not a foster child, and her parents have not yet gone to trial, her death has heightened the focus on the dangers of psychotropic drugs for children in general, several experts said.

"I don't know that we're getting closer to a 'the right kid gets the right drug at the right time' kind of approach," said Julie Zito, a University of Maryland researcher and expert in the use of psychotropic drugs within the foster care population.

Prescribing 'off-label' The Democrat and Chronicle investigation shows that, between 2002 and 2006, the number of county foster children prescribed one or more psychotropic drugs increased about 40 percent, while the total number of foster children decreased slightly. Many of those psychotropic medications have not been approved by the U.S. Food and Drug Administration to address a particular disorder among children. They are prescribed "off-label," which means they can be prescribed for different purposes and to different age groups than those approved by the FDA.

For instance, a drug such as Depakote, approved originally as an adult anti-seizure medication, is now also used to combat bipolar disorder in children, even though it has not been widely tested as a safe bipolar remedy for youngsters. The drug has been linked to liver failure in children younger than 2 and fetal abnormalities in pregnant women.

Large clinical tests of children are uncommon, said Dr. Dianne Murphy, who heads FDA's office of pediatric therapeutics. "The fundamental underpinning of a trial is that the person who is participating does so at their own volition with the full comprehension of what they're doing."

This makes ethical clinical testing of children difficult, she said.

Even within Monroe County, opinions vary about which medications can be used. Several foster care children younger than 5 have been prescribed Depakote, Family Court records and county data show. Data from the county also show that in 2006, Depakote was prescribed for a 1-year-old who was covered by Medicaid but was not in foster care.

The drug's long history as an anti-seizure medication for adults and children is part of the proof physicians rely on when determining whether it can safely be Aadministered to children. Children prescribed Depakote are tested frequently to ensure the drug is not having damaging effects upon the liver or other organs.

Dr. Mohsen Emami, a clinical psychiatrist at St. Joseph's Villa, a local nonprofit residential facility for troubled youths, said he could never imagine a child younger than 5 demonstrating behavior warranting the prescription of Depakote.

"I think sometimes, out of desperation, people turn to medication, but that doesn't necessarily make it right," he said.

The FDA requires that prescription drugs are safe for their planned use. But once on the market, those drugs can then be prescribed for different uses and to different populations, such as children.

Many in the medical community defend off-label prescription, saying that significant advances have occurred with drugs used in ways not originally envisioned. The drugs commonly called beta-blockers, for instance, have been used to treat high blood pressure and congestive heart failure.

In recent years, however, federal regulators have grown more concerned about the increasing use of adult drugs for children.

Eight years ago, between 75 percent and 80 percent of the drugs prescribed for children had not been studied for pediatric use, said FDA's Murphy. In 2002, Congress passed laws providing financial incentives to companies that conducted pediatric testing on medications. Under the law, the companies were granted exclusivity, meaning the time was extended before competing generic brands could be approved and reach the market.

Murphy said regulators are seeing results, but many drugs already commonly prescribed off-label probably won't be tested for pediatric use. A March study by the U.S. Government Accountability Office estimated that about two-thirds of drugs prescribed for children are used off-label, which, the report said, "places children at risk of being exposed to ineffective treatment or incorrect dosing."

Many critics say that, despite the congressional action, far more needs to be done.

"If the United States does not build a more adequate system for studying and monitoring drug safety, then it's reasonable to think, down the road, we're going to see (side effects) in children that are going to surprise us," Zito said.

Multiple meds

While data show an increased use of psychotropic drugs for Monroe County foster children, the use of multiple medications may not be as prevalent here as in other parts of the country.

According to county data, foster children on psychotropic drugs in 2002 were given, on average, prescriptions for 1.34 separate medications. In 2006, that number rose to 1.47 medications, a 10 percent increase.

In Texas, by comparison, the average number of psychotropic drugs used by a foster child prescribed medication was 2.55 in 2004, a study shows.

Because the brains of children are especially active and delicate, many psychiatrists and researchers worry that blending psychotropic drugs could lead to brain damage.

"Clinicians get desperate," said Zito. "You have children who aren't responding (to one drug), so they start adding. This is pretty much art and not science."

"You're accepting a lot of uncertainty in regard to safety as well as no good assurances that children are benefiting," Zito said.

Jessie Sayyeau's experience shows how drugs can add up.

He was removed from his home in 2002 after a Family Court judge determined the environment was neglectful. He started out in foster homes, then was moved to more restrictive facilities outside of the county as his behavior worsened.

After getting the consent of Jessie's mother, Monroe County human services officials approved the combination of drugs prescribed to him.

Without the medications, he would turn increasingly aggressive and could not be calmed down, social workers testified at a Family Court hearing last year.

Transcripts from that hearing show that, while he was at one facility, Jessie received five psychotropic drugs daily.

If those medications did not diminish his aggression, staff would sometimes resort to adding two powerful drugs — Thorazine to combat psychosis and Ativan to control anxiety. Over the course of a month in 2006, Jessie was receiving seven different psychotropic medications almost daily.

This year, a Family Court judge determined that Jessie could return to his mother's care.

Three times a day, he'd take the five mood-changing meds from a palm-sized container. The regimen, which varied depending on the hour, included three anti-psychotic and anti-anxiety drugs — Zoloft, Risperdal and Depakote — and the stimulant drugs Concerta and Ritalin.

Karrie Sayyeau said she is pleased that her son has been weaned to two medications — yet she is also disappointed that many of his past behavioral problems remain.

"I'd rather see him with nothing," she said. "But Jessie is the type of child that needs something."

GCRAIG@DemocratandChronicle.com