The atypical antipsychotic medication Risperdal, manufactured by Johnson & Johnson, was approved by the FDA in 1993 to treat schizophrenia and acute mania, or mixed episodes of bipolar disorder. Risperdal is also prescribed for a number of off-label uses (physicians can prescribe medication although it is not approved for these uses by the FDA) including behavioral disorders in the elderly such as dementia, Attention Deficit Disorder (ADD) and Attention Deficit Hyperactivity Disorder (ADHA) in children, depression, anxiety, and autism. If you feel you have a case regarding the usage of Risperdal and would like to speak with a lawyer, please fill out our case form for a free, no risk evaluation.
On April 16, 2003, Johnson & Johnson, in cooperation with the FDA, released a warning letter to healthcare professionals indicating an increased risk of suffering from cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including death, during trials of Risperdal in elderly patients with dementia.
In July of 2004, the FDA issued another warning regarding the safety of Risperdal and its link to causing hyperglycemia, which can lead to Ketoacidosis, coma, diabetes mellitus, and even death. Johnson & Johnson was required to amend Risperdal's warning label to incorporate these precautions.
Johnson & Johnson, also known as Janssen Pharmaceutica, has touted Risperdal as having a reduced risk of side effects or adverse health reactions in comparison to other atypical antipsychotics. Although the FDA had approved Janssen’s revision to its warning labels regarding the increased risk of hyperglycemia and diabetes mellitus, it concluded that Janssen’s warning letter dated November 10, 2003 contradicted these revised warnings on the product labeling; the warning letter actually claims that Risperdal is associated with a lower risk of diabetes than other atypical antipsychotics. In fact, the FDA summoned Janssen to provide such evidence to support this claim of decreased incidence of hyperglycemia and diabetes.
Other serious side effects that have been associated with Risperdal include pancreatitis, Neuroleptic Malignant Syndrome (NMS), increased levels of prolactin in the body causing gynecomastia (growing of breasts in male and female children and adults), and Tardive Dyskinesia (TD). Other common side effects that can cause injury include dizziness, rapid heartbeat, fainting, seizures, trouble swallowing, cognitive impairment, painful penile erection, suicidal thoughts, vision problems, and uncontrollable motor movements.
Addional links to inform you about Ortho Evra and the FDA: