Drugging fat kids

A pediatric endocrinologist admitted to prescribing amphetamines for about 800 healthy children because they were overweight. The drugs were for attention deficit-hyperactivity disorder and not approved for use in weight loss.

CNN shares the story of one of his patients: a physically active 6th grader who was eating a healthy diet but whose doctor said he was heading for diabetes because he was overweight.

ADHD drug use for youth obesity raises ethical questions

Ziai's approach to treating obesity — he says he has prescribed Adderall for weight loss to about 800 children and teens — raises an important ethical question: Has the obesity epidemic among children become so severe that it's OK to prescribe a drug not approved for weight loss when the drug can have serious, sometimes life-threatening side effects?

Several pediatricians contacted by CNN say they suspect other pediatricians are prescribing ADHD medications off label for weight loss. “No one admits it," says Dr. John Lantos, professor of pediatrics at the University of Chicago. “It's morally and medically questionable, so I don't think anyone's proud of doing this."

Pediatricians like Lantos say it's wrong to prescribe Adderall for weight loss when risks are known and the benefits are questionable. The drug has never been studied for weight loss, so they suggest that Ziai's success stories may be anecdotal. "Doctors who prescribe this could end up killing kids by giving them a medication that doesn't work for the reason they're prescribing," Lantos says....

Ziai says [amphetamine] is the only option for many of his overweight kids.

Concerns being raised over the off-label use of amphetamines on fat children, however, appear substantiated. Last year, an FDA advisory panel was so concerned by reports of adverse reactions of these ADHD amphetamines that in August the FDA requested manufacturers issue “Dear Healthcare Professional” letters concerning a new black box warning and additional warnings to alert medical professionals that these drugs may cause sudden death and serious cardiovascular events.

According to GlaxoSmithKline’s letter (available on the FDA site here): “Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems.”

It also reported on the results of a randomized, placebo-controlled clinical trial of children 7 to 10 years of age on an amphetamine for 14 months and on a study of children 10-13 year old treated in the community for three years. They found that there was a growth retardation of 2 cm in height and 6 pounds in weight over three years and that normal development didn’t rebound. “Published data are inadequate to determine whether chronic use of amphetamines may cause a similar suppression of growth, however, it is anticipated that they likely have this effect as well.”

The letter also described blood pressure and heart rate elevation, higher rates of behavioral and psychiatric disorders, manic and psychotic symptoms, and aggression and hostility observed in children and adolescents.

Merck’s amphetamine warnings add:“Heart attacks have occurred, even in healthy young athletes. Blood pressure may become so high that a blood vessel in the brain ruptures, causing a stroke. Complications are more likely when drugs ... are used in warm rooms with little ventilation, when the user is very active physically.”

The latest 2006 Drug Abuse Warning Network (DAWN) report, “Emergency Department Visits Involving ADHD Stimulant Medications,” said that in 2004 nearly 8,000 visits to the emergency room and more than 600 suicide attempts involved just two of ADHD medications [Methylphenidate (Ritalin and Concerta) or amphetamine (Dexedrine and Adderall)].

About one-third of these ER visits were among children taking them as prescribed. Teens taking these medications to treat ADHD have 1.6 emergency room visits per 100,000 but DAWN found these pills were being used non-medically in growing numbers of young adults. The Substance Abuse and Mental Health Services Administration (SAMHSA) Acting Deputy Administrator said “these findings suggest an alarming level of non-medical use that could have life-threatening consequences, such as heart attack or stroke.”

Has the hysteria over weight really come down to this? The risks of off-label amphetamines versus questionable benefits for healthy, active children: it may be legal, but is it good medicine?