The research looked at the two most common ADHD treatments and found that, although the risk of psychosis is low, it is higher for patients taking amphetamines (marketed as Adderall and Vyvanse) than for those taking methylphenidates (marketed as Ritalin or Concerta).
Researchers at McLean Hospital and Harvard Medical School reviewed the data of 221,846 patients (ages 13 to 25) diagnosed with ADHD who started taking amphetamines or methylphenidate between January 1, 2004, and September 30, 2015.
They found that one in every 486 patients started on an amphetamine developed psychosis that required treatment with antipsychotic medication compared to 1 in 1,046 patients started on a methylphenidate.
“The findings are concerning because the use of amphetamines in adolescents and young adults has more than tripled in recent years. More and more patients are being treated with these medications,” said researcher Lauren V. Moran, M.D., and lead author of the paper.
“There is not a lot of research comparing the safety profiles of amphetamines and methylphenidate, despite increasing use of these medications,” said Moran, although clinicians have long observed “patients without previous psychiatric history coming with psychosis in the setting of stimulant use.”
Despite the increased risk, Moran emphasizes that the study was limited to youth who had been recently diagnosed with ADHD and therefore only recently begun treatment. “People who have been on a drug like Adderall for a long time who are taking the drug as prescribed and are tolerating it well are not likely to experience this problem” said Moran.
The analysis is the first to use ADHD drug data taken from routine patient care rather than clinical trial data. Using this type of data ensures that study results reflect treatment patterns in large and varied populations, in contrast to the precisely uniform care received by subjects in controlled research trials. As a result, the findings are more likely to be relevant to a wide group of patients.
“We analyzed two large insurance claims databases to understand the risk for patients who start taking amphetamines to treat ADHD in a way that aligns with real-world evidence generation processes suggested by regulatory agencies,” said Sebastian Schneeweiss, M.D., Sc.D., professor at Harvard Medical School.
“The study illustrates the importance of using data from the real world, from diverse patients, to better understand the safety of commonly prescribed medications and allow physicians to weigh benefits and risks.”
The research paper is published in the New England Journal of Medicine.
Source: McLean Hospital