April 18, 2000 (Washington) -- Could a 14-year old Michigan boy's death last month be the result of damage caused by years of taking Ritalin? The stimulant drug used by millions for the treatment of attention deficit hyperactivity disorder (ADHD) is considered extremely safe, but a county medical examiner says Ritalin was the likely cause of Matthew Smith's heart attack on March 21.
In the wake of the incident, the FDA has opened an investigation, and Smith's parents have indicated their intention to file a lawsuit against Novartis, the drug's manufacturer. "Although we continue to be confident in the safety of our product, we cannot make any additional comments on a matter that will be before the courts," Novartis company spokesman Harry Rohme tells WebMD.
Ljubisa Dragovic, MD, chief pathologist of the Oakland County Medical Examiner's office, tells WebMD that after a thorough analysis he concluded the boy's small blood vessels showed scarring and tissue growth consistent with chronic stimulant use. According to Dragovic, Matthew had earlier complained of chest pains, then collapsed while playing on a skateboard. He had been taking Ritalin for 10 years.
Since it was a sudden, unexplained death, Dragovic was called in to investigate. He says it appears the drug affected pathways throughout the nervous system over time, causing "gradual, low level" damage. Although Dragovic says he has never seen a case like this one, he would still caution parents against using Ritalin because it's difficult -- if not impossible -- to diagnose such a problem before it kills.
After Dragovic reported the death to the FDA, the agency began its inquiry, according to spokeswoman Susan Cruzan. However, she says it's too soon to see if any kind of regulatory action might be necessary.
ADHD is characterized by an inability to maintain attention and concentration, according to a National Institutes of Health consensus conference in 1998. Perhaps as many as 5% of American schoolchildren are affected. Ritalin is a popular but controversial treatment for the condition, because many in the field believe the drug is often prescribed simple to control behavior. The drug works by mildly stimulating the central nervous system.
Peter Breggin, MD, director of the Center for the Study of Psychiatry and Psychology, is a critic of drug therapy for mental illness. He tells WebMD that there's animal research documenting Ritalin's ability to damage the heart, and Breggin feels that the Michigan case is the "tip of the iceberg."
However, a guideline issued by the American Heart Association in 1998 concluded, "no specific [heart] monitoring is necessary for most children on Ritalin."
C. Keith Connors, PhD, also tells WebMD that there's no evidence the proper dose of Ritalin can hurt the heart. Connors is director of the ADHD Program at Duke University Medical Center.
Connors says it's highly unlikely that Ritalin was responsible for Matthew Smith's death. "With the millions of children, adolescents, and adults who are taking Ritalin, there are going to be a lot of people who die from a lot of different causes ... but that has nothing to do with any casual explanation or proof," he tells WebMD.
Nonetheless, Dragovic says he believes his findings are "definitive," and there is evidence of other heart problems in Ritalin users.