Methylphenidate (Ritalin) is a medication prescribed for individuals (usually children) who have attention-deficit hyperactivity disorder (ADHD), which consists of a persistent pattern of abnormally high levels of activity, impulsivity, and/or inattention that is more frequently displayed and more severe than is typically observed in individuals with comparable levels of development. The pattern of behavior usually arises between the ages of 3 and 5, and is diagnosed during the elementary school years due to the child’s excessive locomotor activity, poor attention, and/or impulsive behavior. Most symptoms improve during adolescence or adulthood, but the disorder can persist or present in adults.
It has been estimated that 3–7 percent of school-age children have been diagnosed with ADHD.
Methylphenidate also is occasionally prescribed for treating narcolepsy.
-NIDA InfoFacts Report 2006
Ritalin ranks in the 'Top 10' controlled drugs stolen from doctors and pharmacies, according to the U.S. DEA. Its street names include "Vitamin R" and "R-Ball." Ritalin is also a gateway drug to harder drugs such as marijuana, cocaine and heroine.
In a 1997 Indiana University survey of 44,232 students, nearly 7 percent of high school students said they had used Ritalin recreationally at least once in the previous year; 2.5 percent said they used it at least once a month. (ABC News)
Peter R. Breggin M.D. Testimony September 29, 2000
Before the Subcommittee on Oversight and Investigations
Committee on Education and the Workforce
U.S. House of Representatives
" Stimulant drugs, including methylphenidate and amphetamine, were first approved for the control of behavior in children during the mid-1950s. Since then, there have been periodic attempts to promote their usage, and periodic public reactions against the practice. In fact, the first Congressional hearings critical of stimulant medication were held in the early 1970s when an estimated 100,000-200,000 children were receiving these drugs.
Since the early 1990s, North America has turned to psychoactive drugs in unprecedented numbers for the control of children. In November 1999, the U.S. Drug Enforcement Administration (DEA) warned about a record six-fold increase in Ritalin production between 1990 and 1995. In 1995, the International Narcotics Control Board (INCB), a agency of the World Health Organization, deplored that “10 to 12 percent of all boys between the ages 6 and 14 in the United States have been diagnosed as having ADD and are being treated with methylphenidate [Ritalin].” In March 1997, the board declared, "The therapeutic use of methylphenidate is now under scrutiny by the American medical community; the INCB welcomes this." The United States uses approximately 90% of the world's Ritalin.
The number of children on these drugs has continued to escalate. A recent study in Virginia indicated that up to 20% of white boys in the fifth grade were receiving stimulant drugs during the day from school officials. Another study from North Carolina showed that 10% of children were receiving stimulant drugs at home or in school. The rates for boys were not disclosed but probably exceeded 15%. With 53 million children enrolled in school, probably more than 5 million are taking stimulant drugs.
A recent report in the Journal of the American Medical Association by Zito and her colleagues has demonstrated a three-fold increase in the prescription of stimulants to 2-4 year old toddlers."
Trends in Illegal Ritalin Use
Monitoring the Future (MTF) Survey
Each year, MTF assesses the extent of drug use among adolescents and young adults nationwide. MTF 2005 data on annual use indicate that 2.4 percent of 8th-graders used Ritalin, as did 3.4 percent of 10th-graders and 4.4 percent of 12th-graders.
National Survey on Drug Use and Health (NSDUH)
According to the 2004 NSDUH, there was a decline in lifetime use among those aged 12 to 17, from 2.2 percent in 2003 to 1.8 percent in 2004.
Study Sparks Debate on Ritalin Use in Preschoolers
SATURDAY, Oct. 21 (HealthDay News) -- A new national study that raises the possibility of preschoolers with attention-deficit hyperactivity disorder taking Ritalin has sparked a debate over the safety and appropriateness of such a practice.
"This drug doesn't work as well in preschoolers as it does in older kids, and there are more adverse effects and a higher drop-out rate in this group," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "In addition, there is an explicit statement [in the study] saying that the size of this study is too small to conclude that this drug is safe and, to me, that is as important as anything."
The National Institute of Mental Health (NIMH), which funded the study, however, says the drug might be useful in certain severe cases of attention-deficit hyperactivity disorder (ADHD).
"Going into this, we had no data with which to know whether the medication was effective or safe, and what we know coming out of it is that there is some evidence of benefit in this young age group, but less than what we see with older children, and the risks are somewhat greater," said NIMH Director Dr. Thomas Insel. "We are recommending to clinicians and families that the drug should be considered as one of many options that can be used in very young children with severe ADHD, and I underline severe. If it's going to be used, it needs to be used carefully with careful monitoring," he added.
Others agreed that Ritalin should be considered on a case-by-case basis. "It is well known that ADHD has its onset usually between 3 to 4 years of age, so it is only reasonable if behavioral and psychosocial interventions fail that we consider the use of psychostimulants such as Ritalin, as this intervention is successful at least 70 percent of the time," said Dr. Jon A. Shaw, director of child and adolescent psychiatry at the University of Miami Miller School of Medicine. "It's a cost/benefit decision that parents have to judiciously consider, weighing the risk of side effects and the benefits of helping a child to control himself/herself."
Ritalin (methylphenidate) is used to treat ADHD but is not approved for children under the age of 6, although Insel said that about 1.2 percent of preschool kids are already receiving the drug. Such "off-label" prescribing is not illegal.
Even in older children, the drug has had its share of controversy. The U.S. Food and Drug Administration pediatric advisory committee recently met to consider whether ADHD drugs including Ritalin should carry a black box warning to highlight the possible risks of psychosis, mania and cardiovascular problems. In the end, the committee voted against a black-box warning but recommended the label use simpler language and include more information.
According to the Associated Press, about 8 percent of U.S. children have ADHD, including around 3 percent of preschoolers.
The study that sparked the latest controversy is the first, long-term government trial of Ritalin in preschoolers and is in the November edition of the Journal of the American Academy of Child and Adolescent Psychiatry.
Several of the study's authors have financial ties with companies that make the drugs.
The Los Angeles Times reported that the trial was initiated in response to the outcry that ensued when the Journal of the American Medical Association claimed that as many as 200,000 preschoolers were taking Ritalin off-label.
The trial involved 183 children with severe cases of ADHD who took Ritalin for about a year. Thirty percent of parents reported moderate to severe adverse events in their children, including emotional outbursts, difficulty sleeping, decreased appetite and irritability. About 11 percent of children dropped out because of side effects.
The preschoolers taking the drug also grew about a half inch less and gained about two pounds less than expected for their age.
Improvements in behavior were seen in children taking 7.5 to 30 milligrams daily, with the optimal dose being 14 milligrams daily. That is less than half the usual dose for older children.
The size of the study was a major sticking point for critics. "If you're worried about some serious adverse effects, you'd never see it in 183 kids," Wolfe said. "They specifically say this should be studied in at least 1,500 kids, which is seven times more than it was."
"Is there enough evidence for this drug to be approved for this group of preschool children for which it is currently not approved? The answer is clearly no. The authors themselves say no," he continued. "People should be extremely careful about giving this to young kids."
Insel said he suspected the drug's maker would not seek approval for this indication. "It's being used so widely, I don't know that they need to do any marketing," he added.
Insel also said he did not believe the study was that small and that, in fact, investigators had gone into the trial feeling that it would show that the drug should not be used. "The evidence does not bear that out," he said.
But long-term follow-up still needs to be done.
"What we don't know, and I think this is critical for parents, is what the long-term issues are," Insel said. "Are we altering brain development or is this a case in which the natural course of brain development has already been altered by a disorder, and we're in some ways mitigating those effects? We will need long-term follow-up, and that's in the works."
