Big data study identifies drugs that increase risk of psychosis in youth with ADHD March 20, 2019

In a paper recently published in the New England Journal of Medicine, researchers from McLean Hospital and Harvard Medical School said that certain drugs prescribed to teens and young adults with ADHD increase the risk of psychosis.

The study, funded by the National Institutes of Health, analyzed data from commercial insurance claims using the Aetion Evidence Platform™. The Aetion platform uses real-world data to quickly generate regulatory-grade evidence. It is also being used by the FDA in its ongoing real-world evidence demonstration program.

The researchers evaluated the two most common treatments for ADHD and found that, although the risk of psychosis is low, it is greater for patients who are taking amphetamines such as Adderall and Vyvanse than for those taking methylphenidates such as Ritalin or Concerta.

“These findings are concerning because the use of amphetamines in adolescents and young adults has more than tripled in recent years,” said researcher Lauren V. Moran, MD. “There is not a lot of research comparing the safety profiles of amphetamines and methylphenidate, despite increasing use of these medications,” although clinicians have long observed “patients without previous psychiatric history coming with psychosis in the setting of stimulant use.

Using the Aetion Evidence Platform, the study examined information from two large commercial insurance claims databases on patients ages 13 to 25 years old with ADHD, who started taking amphetamines or methylphenidate between 2004 and 2015. That data comprised 221,846 people. The researchers found that one out of 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.

“We analyzed two large insurance claims databases to understand the risk for people who start taking amphetamines to treat ADHD in a way that aligns with real-world evidence generation processes suggested by regulatory agencies,” said Aetion co-founder and report author Sebastian Schneeweiss, MD, ScD. “The study illustrates the importance of using data from the real world, from diverse patients, to better understand the safety of commonly prescribed emdications and allow physicians to weigh benefits and risks.

Read the original press release here.

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