ATTENTION: RISPERDAL HAS BEEN LINKED TO MALE BREAST GROWTH, A CONDITION KNOWN AS GYNECOMASTIA.
Risperdal (risperidone) was originally developed as a treatment for schizophrenia and approved by the U.S. Food and Drug Administration for this purpose in 1993. Risperdal is now prescribed by doctors to treat a variety of mental and mood disorders, including:
- Bipolar disorder
- Obsessive compulsive disorder (OCD)
- Irritability associated with autistic disorder
The drug works by blocking the brain’s receptors for dopamine and serotonin, helping to improve thinking, mood and behavior.
After it’s approval for schizophrenia, researchers began investigating whether risperidone, the generic form of Risperdal, would be an effective treatment for children with autism.
The theory was that the medication could potentially help autistic children with “explosive and aggressive behavior.”
A 2002 randomized clinical trial of autistic children between the ages of 5 and 17 showed that those who took risperidone reduced their tantrums, aggression and self-injury by 57 percent. Those who took a placebo saw a 14 percent reduction in these behaviors. Out of the children who responded positively to risperidone (Risperdal), close to 70 percent continued to show improvements six month after taking the drug.
In 2006, FDA approved risperidone as a treatment for autism irritability in children between the ages of 5 and 16.
The second-generation anti-psychotic drug was found to be effective both in children who acted out after being provoked as well as those who manifested unprovoked aggression. It has been found to help patients think more clearly and participate in everyday life.
RISPERDAL SIDE EFFECTS
Like all antipsychotic meds, Risperdal patients are at an increased risk of weight gain.
Researchers found that after six weeks of a standard dose of risperidone, children had greater increases in insulin levels and insulin resistance than children taking a placebo. Children taking risperidone gained an average of six pounds within the first two months of starting the medication.
Other Risperdal side effects seen in patients are insomnia, agitation and restlessness, headache, runny nose, tremors and an abnormal gait.
A less common Risperdal side effect is tardive dyskinesia, or uncontrollable muscle movements, which most often affects the face, mouth and tongue but can affect any part of the body.
Perhaps the most widely publicized Risperdal side effect is gynecomastia, commonly known as man boobs, a condition that causes male breast growth and may require surgery to correct.
As with many antipsychotic drugs, Risperdal increases levels of prolactin, a hormone secreted by the pituitary gland. This can cause boys to develop breasts or “man boobs.”
RISPERDAL GYNECOMASTIA LITIGATION
In 2015, a Philadelphia jury awarded $2.5 million in damages to 20-year-old plaintiff A. Pledger, an autistic Alabama man who developed size 46DD breasts after he began taking Risperdal in 2002, when he was 8 years old. The FDA didn’t approve the drug for children and adolescents until four years after Pledger started on the medication.
Pledger needs a mastectomy to get rid of his Gynecomastia induced male breast growth, according to his lawyer. Pledger’s case was the first of thousands of Risperdal lawsuits nationwide to go to trial.
In 2016, another Philadelphia jury awarded a Tennessee teen who began taking Risperdal at age 5 for a psychiatric disorder a record-setting $70 million Risperdal lawsuit settlement, which included an award for emotional distress. A judge tacked on an additional $6.6 million in delay damages to be paid by Johnson & Johnson subsidiary Janssen Pharmaceuticals.
Jurors found that Johnson & Johnson failed to adequately warn the child and his parents about the risk of male breast tissue development. The teen’s legal team also argued that Johnson & Johnson kept secret the results of a medical study indicating Risperdal caused abnormal breast development in boys.
It was the fifth verdict against Johnson & Johnson for allegedly failing to properly warn users and doctors about the Risperdal gynecomastia risk. Earlier verdicts ranged from $500,000 to $2.2 million.
As of July 2016, some 12,000 Risperdal lawsuits had been filed against Johnson & Johnson and Janssen, according to Reuters.
Forbes reported that in the first three months of 2017, more than 3,000 new Risperdal lawsuits had been filed in the Philadelphia County Court of Common Pleas, bringing the total number of Risperdal lawsuits there to 5,500.
This wave of lawsuits isn’t the first time Risperdal has been the focus of litigation.
In 2013, after the Department of Justice launched civil and criminal investigations related to the marketing tactics of Risperdal and two other drugs, Johnson & Johnson and Janssen Pharmaceuticals paid in excess of $2.2 billion to resolve accusations that the drug makers promoted the medications “for unapproved uses, including controlling aggression and anxiety in elderly dementia patients and treating behavioral disturbances in children and in individuals with disabilities.”
The settlement, according to the Associated Press, was the third largest with a drug maker in U.S. history.
GET A FREE CASE EVALUATION
If you or your son took Risperdal and developed side effects such as Gynecomastia (male breast growth), painful breasts, lactation or other similar issues, you may have a legal claim.
To see if you or a loved one qualify to file a Risperdal lawsuit complete the form on this page. A Risperdal lawyer will review your claims for free and contact you if you have a case.