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Risperdal Overview
Johnson & Johnson makes Risperdal, which was FDA-approved in the 1990s to treat schizophrenia and bipolar disorder. Today, Risperdal, generically known as risperdone, often treats aggressive or irritable children.
Even though the FDA has approved Risperdal to treat a child with autism who has tendencies toward self-harm or excessive aggression, the drug often also is prescribed for children with other maladies. Risperdal prescriptions have been written for children suffering from attention-deficit hyperactivity disorder (ADHD), disruptive mood dysregulation disorder (DMDD) or oppositional defiant disorder (ODD). And according to the Child Mind Institute, Risperdal appears to work well in off-label situations in children who have received a diagnosis of autism and who have exhibited dangerously aggressive behavior.
Doctors are allowed to prescribe medications for off-label reasons, but the drug companies are only allowed to market their medications for the FDA-approved reasons.
In several lawsuits around the country, Johnson & Johnson sales representatives have been accused of marketing the drug for use by children before the FDA approved it for children.
Risperdal Side Effects
Children and adults who take Risperdal may experience fatigue, dizziness, drooling, nausea or weight gain. More serious side effects may include difficulty swallowing, muscle spasms, tremors, mental or mood changes such as anxiety, or sleep apnea.
In some patients, Risperdal may cause an increase in blood sugar levels, which can wreak havoc in patients with diabetes. Symptoms of high blood sugar can include excessive thirst and increased urination.
The weight gain associated with Risperdal may be fast and excessive. A 2009 study conducted by psychiatric researchers at Zucker Hillside Hospital in Glen Oaks, New York found that after nearly 11 weeks of treatment with Risperdal, children gained more than 11 pounds. A control group who took a placebo (fake pill) gained less than a half a pound during that time period.
In young males, a condition known as gynecomastia (enlarged male breasts) may occur. Risperdal elevates the level of a certain hormone called prolactin, which is responsible for the lactation development in pregnant women. Scientists believe this hormonal imbalance may cause male Risperdal patients to develop breasts.
Gynecomastia is not a byproduct of excessive weight gain, because the developed breasts are made of glandular tissue, not just fatty tissue. As a result, young men may have to undergo surgery to reduce the size of their breasts because simply losing weight will not reduce their size.
$8 Billion Gynecomastia Verdict
In a recent lawsuit brought by a 26-year-old man who said he developed breasts when he started taking Risperdal at age nine, a Pennsylvania jury awarded $8 billion in punitive damages.
Plaintiff Nicholas M. filed suit against Johnson & Johnson, accusing the drug company of failing to warn boys that they could develop breasts as a side effect of taking Risperdal.
Murray is one of thousands of Risperdal patients who have reported breast growth, painful breasts, nipple pain or nipple discharge, allegedly due to Risperdal. Johnson & Johnson currently is facing more than 10,000 Risperdal lawsuits.
