More Kids Using Risperdal Despite Serious Side Effects
Written by Stephen Fields on November 23, 2013
In 2008, the FDA convened a panel of drug experts to review the safety of antipsychotics like Risperdal in children. In the previous 15 years, the number of children taking these drugs had grown by over 5 times; hundreds of thousands of children were taking the drug every day.
The FDA suggested that this committee of doctors endorse the way that it was monitoring the safety of these drugs and children. In a surprise turn, however, the doctors did not support the FDA’s actions. Instead, they argued that, because of Risperdal’s serious side effects, it should be prescribed less frequently in children.
Dr. Daniel Notterman, a senior health policy analyst at Princeton, suggested that perhaps more needed to be done to publicize the serious side effects associated with drugs like Risperdal.
Large Percentage of Juvenile Risperdal Use is Off Label
Of particular concern to the committee was the growing number of children were being prescribed Risperdal for so-called “off label” uses, particularly attention deficit disorders.
Until late 2006, Risperdal was not approved in children for any use. Then, it was approved for treatment of irritability in children and adolescents with autism. A year later, it was also approved for treatment of schizophrenia in children 13-17 and bipolar disorder in children ages 10-17.
However, as Dr. Mark Olfson of the Columbia University Medical Center has noted, only a small percent (6% for children, 13% for adolescents) of antipsychotic prescriptions are written for approved uses.
The majority of prescriptions for young people are being used to control children with conditions like ADHD and other behavior, for which the drug has never been studied or approved. As a US News and World Report stated, many of these medications are being written by doctors who were not psychiatrists.
Dr. Peter Breggin, a psychiatrist from Ithaca, NY believes these drugs damage developing brains. “We have a national catastrophe,” said Breggin. “This is a situation where we have ruined the brains of millions of children.” 1
Even some of the drug’s approved uses have come under fire. More and more children have been diagnosed with pediatric bipolar disorder in recent years, a number of whom have subsequently been prescribed antipsychotics.
However, Harvard University’s Dr. Joseph Biederman has been widely criticized for research studies of the drugs he advocates, as well as for accepting at least $1.4 million in unreported income from the makers of antipsychotic medications like Risperdal. Some allege that these payments may have influenced his promotion of diagnosing bipolar disorder in children.2
Serious Risperdal Side Effects Identified in Children
Whether juveniles are taking Risperdal for approved or off-label uses, they face the risk of serious side effects. Families have reported substantial weight gain, metabolic disorders, and permanent muscular tics or twitches. It has been linked to a 3-fold risk of diabetes in children.
Young men prescribed Risperdal have developed breasts and been forced to endure double mastectomies to remove them. Both boys and girls have been reported to lactate while taking this drug.
From 1993-2008, over 1,200 children suffered serious problems while taking Risperdal; 31 died. One 9-year old suffered a fatal stroke 12 days after starting the drug. At least 11 of those who died were using the drug for an off-label use, the New York Times reported.
Sadly, some parents who treated their children with Risperdal feel that they did not fully understand the risks that this drug posed. There has been a particularly vocal outcry about the drug’s link to breast growth in boys, with parents asserting that Risperdal’s label did not adequately disclose this side effect.
Some families have gone on to file lawsuits against Johnson & Johnson, asserting that the company’s warnings about Risperdal and gynecomastia, or breast growth, were not strong enough, putting their children’s health at risk.
If you or your son developed breasts while taking Risperdal, you may also be eligible to receive a settlement from Johnson & Johnson.
Please contact our attorneys at 1-888-210-9968 to learn more about Risperdal litigation. There is no cost to receive a consultation, and there are never any legal fees unless you win compensation in your case.