In 1993, the Food and Drug Administration (FDA) approved the antipsychotic medication Risperdal (risperidone) to treat manic or mixed delusional episodes in adult patients with schizophrenia. Fourteen years later that the FDA expanded the indication to include children and adolescents, but only for the treatment of schizophrenia and bipolar disorder.
Yet, between 1993 and 2008, Risperdal was being administered “off label” to thousands of children, many of whom suffered complications from the drug, including death. In fact, the FDA ordered Johnson & Johnson in 2001 to change the drug’s label stating that the safety and efficacy of Risperdal in children had not yet been established.
Risperdal’s label has since been expanded to include the treatment of irritability associated with autism in both adults and children. However, the drug is still prescribed off-label to both adults and children for conditions ranging from Tourette’s syndrome to attention deficit hyperactivity disorder (ADHD).
Studies have shown Risperdal can cause dangerous side effects including metabolic changes leading to type 2 diabetes, a movement disorder known as tardive dyskinesia, and a life threatening neurological disorder called neuroleptic malignant syndrome, conditions that are outlined on the drug’s safety label. However, Risperdal use in boys and young men has also been linked to hormonal imbalances that can lead to the development of female breasts, a condition known as gynecomastia.
The condition is embarrassing and can cause symptoms such as breast tenderness and nipple discharge. Treatment often requires surgery such as liposuction or mastectomy. Boys with gynecomastia are also at an increased risk of breast cancer and may suffer harm to their reproductive system.
Young men who have filed Risperdal lawsuits have spoken out about the emotional toll the condition has taken on them. The lawsuits allege that Johnson & Johnson and its unit Janssen Pharmaceuticals knew of the gynecomastia risk associated with Risperdal as early as 2006 but failed to warn consumers, opting instead to push forward with plans to get the drug approved for use in children and adolescents.
Source: Legal Examiner