In a recently published study in the Journal of Child and Adolescent Psychopharmacology, researchers are reporting that atypical anti-psychotic drugs like Risperdal are being overprescribed in foster children who suffer from ADHD. In fact, the study shows that nearly a third of all foster children (ages 2 to 17) who have been diagnosed with ADHD are being treated with one of these medications.
“Over the last two decades,” the authors wrote, “the increased use of second-generation antipsychotic medications, that is, atypical antipsychotics, has been profound.”
This information is stunning for a variety of reasons but most notably because, though the FDA approved the use of Risperdal in children in 2006, it only did so within the tight parameters of short-term treatment of schizophrenia in adolescents aged from 13 to 17 and short term treatment of manic or mixed episodes of bipolar I disorder in children aged between 10 and 17 and in irritability associated with autistic disorders in children ages 5 to 16 years. It has never been approved for long-term use in children or to treat Attention Deficit or Hyperactivity disorders or any other types of behavioral problems in children.
This kind of off-label use is also particularly alarming in light of some of Risperdal’s serious side effects, which include heart attack, stroke, diabetes, tardive dyskinesia (an often incurable involuntary movement disorder that affects the facial muscles and sometimes other body parts), and gynecomastia.
Risperdal and Gynecomastia
Gynecomastia, the abnormal development of breast tissue in males, both men and boys (as young as four), has been at the center of many of the recent Risperdal lawsuits. With plaintiffs alleging that Johnson & Johnson (and its pharmaceutical division, Janssen) hid this potential side effect from doctors and patients.
Because Risperdal blocks dopamine (the primary neuroendocrine inhibitor of prolactin) it frees the pituitary gland to produce prolactin. This results in the growth of breast tissue and even lactation in some cases. This leaves the patients, who are often young boys who are still in various stages of development, with few options to correct this condition, namely liposuction and in severe cases, mastectomy – two very serious and invasive procedures for someone so young.
Beyond the physical symptoms, which include swollen and tender breast tissue, gynecomastia can also lead to psychological issues for patients, as they struggle to deal with this noticeable side effect.
Examining the administrative data of more than 260,000 youths, aged 2 to 17, enrolled in the state’s Medicaid program in 2006, researchers at the University of Maryland at Baltimore analyzed those who were prescribed anti-psychotic medications, and how long they took them. They also looked at a subgroup of kids with ADHD who were not diagnosed with any other mental health conditions.
The results showed that kids enrolled in the foster care system had three times greater use of antipsychotic drugs, including Risperdal, Abilify, and Seroquel, regardless of their age and that Risperal was among the most-frequently used antipsychotics in those foster kids with ADHD.
“This study adds critical hard data to our understanding of a persistent and unacceptable trend in pediatric psychiatry,” said Dr. Harold Koplewicz, journal editor-in-chief and president of the Child Mind Institute in New York City. “Our poorest, most vulnerable children, lacking access to evidence-based care, are receiving potentially harmful treatment with little oversight. “
An analysis by Mathematica Policy Research Data mirrors those findings, showing that the number of youth (under the age 20) that received Medicaid-funded prescriptions for antipsychotic drugs also tripled between 1999 and 2008.
In some areas the problem is even greater than the national average, as illustrated by a recent article in the Denver Post , discussing the fact that drug companies have been over-promoting their products for use in children and adolescents. Their 2012 investigation into the use of antipsychotics in foster children found that foster children were “prescribed the mood-altering drugs at a rate 12 times higher than that of other children on Medicaid in Colorado in 2012.”
Pharmaceutical Companies: Drug Pushing Kids
Victims of Risperdal’s serious list of side effects have filed lawsuits against manufacturer Janssen Pharmaceuticals and their parent company Johnson & Johnson (J&J). There are 300 cases currently pending in the Philadelphia Court of Common Pleas, where a mass tort has been established.
Johnson & Johnson was also ordered back in November 2013, to pay “$2.2 billion in fines arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider,” according to the U.S. Department of Justice.
One of the largest health care fraud settlements in U.S. history, the resolution includes criminal fines and forfeiture for violations of the law and civil settlements based on the False Claims Act arising out of multiple investigations of the company and its subsidiaries including that they had targeted “key opinion leaders” to promote the use of Risperdal in children.
If you or a loved one have used Risperdal and suffered from gynecomastia, you may have legal recourse to collect compensation for your damages. Don’t settle for an inexperienced attorney. The experienced class action lawyers at Meshbesher & Spence will help you seek compensation for your injuries. Experience does make a difference. Please fill out the case evaluation form or call our offices to speak to an attorney today. There is no cost of obligation to have your claim reviewed.