Risperdal Side Effects: Children on Antipsychotics Face Higher Death Risk

Published on January 4, 2019 by Sandy Liebhard

Children treated with Risperdal or other antipsychotic medications may face a higher risk of death, according to newly-published research.

How the Study Was Conducted

Antipsychotics like Risperdal can cause potentially deadly cardiovascular and metabolic side effects.  However, a study published online last month by JAMA: Psychiatry is one of the first large studies to examine whether children are at a greater risk of death from these issues.

The investigation involved 247,858 Medicaid-enrolled children and youths in Tennessee who were new users of antipsychotic drugs or control medications (including ADHD drugs, antidepressants, or mood stabilizers).

Of these, 28,377 received antipsychotics at a dose higher than 50mg, while 30,012 received the drugs at a lower dose. The remaining subjects were treated with the control drugs.

During the course of the investigation:

  • 40 deaths occurred in the high-dose group, or 2 per 100,000 person-years.
  • 8 deaths occurred in the low-dose group, or 49.5 deaths per 100,000 person-years.
  • 67 deaths occurred in the control group, or 54.4 deaths per 100,000 person-years.

The research team classified the deaths as either injury or suicide; unexpected death not because of overdose; or unexpected death because of cardiovascular or metabolic causes.

The Study’s Conclusions

According to the authors of the study, children in the high-dose group were 1.8 times more likely to die compared to those taking control medications. They were also 3.5 times more likely to die of unexpected causes (not including overdose), and 4.29 times more likely to die of cardiovascular or metabolic problems.

The difference in death rates between the low dose and control groups was not considered statistically significant. In addition, deaths from suicide were no different between the three groups.

“The findings suggest that antipsychotic use is associated with increased risk of unexpected death and appear to reinforce recommendations for careful prescribing and monitoring of antipsychotic treatment for children and youths and to underscore the need for larger antipsychotic treatment safety studies in this population,” the study authors concluded.

Risperdal Lawsuits for Gynecomastia

Risperdal was approved to treat adult and adolescent schizophrenia, bipolar disorder in adults and children ages 10-to-17, and irritability in children (5-to-16 years of age) with autistic disorder. It is also frequently prescribed off-label to treat children with ADHD.

Thousands of plaintiffs are currently pursuing Risperdal lawsuits for gynecomastia, a condition that causes men and boys to develop female-breasts. Many of these plaintiffs were treated with Risperdal as children, often years before the antipsychotic drug was approved for any pediatric indications.

One of the nation’s largest Risperdal gynecomastia litigations is currently underway in the Philadelphia Court of Common Pleas in Pennsylvania. The proceeding has convened several trials since February 2015. So far, four juries have found for plaintiffs, with compensatory damage awards ranging from $2.5 million to $70 million.

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