Hyperosmolar Coma Risperdal
Connections between Risperdal and Hyperosmolar Coma are being investigated by Risperdal lawyers all over the country. If you or a loved one has been diagnosed with this serious medical condition, you may be entitled to a financial reward. Contact a Risperdal attorney today to discuss for FREE.
When the first atypical antipsychotic drugs were introduced in the United States, drug companies touted the medications as superior in safety to conventional antipsychotics, due mostly to their apparent avoidance of tardive dyskinesia, a known side effect of first-generation antipsychotic drugs like haloperidol (Haldol). In 1993, Johnson & Johnson introduced its second-generation antipsychotic Risperdal (risperidone), and it quickly become one of the most widely prescribed antipsychotic medications on the market. Despite the popularity of Risperdal and other antipsychotics however, mounting research has indicated that patients taking these drugs to treat psychiatric disorders like schizophrenia and bipolar disorder may be at an increased risk for serious side effects. Among the side effects potentially linked to Risperdal are heart attack, stroke, tardive dyskinesia, gynecomastia (male breast growth), diabetes and hyperosmolar coma.
Signs and Symptoms of Hyperosmolar Coma
A hyperosmolar coma is a serious complication of diabetes – predominantly Type 2 diabetes – in which extremely high blood sugar levels (hyperosmolarity) and severe dehydration alone are enough to cause unconsciousness. Some common symptoms of hyperosmolarity include:
Also known as a hyperosmolar nonketotic coma, a hyperosmolar coma is actually one of three different types of diabetic coma, along with diabetic ketoacidosis (a coma caused by severe hyperglycemia, dehydration, shock and exhaustion) and severe diabetic hypoglycemia (low blood sugar levels). Depending on the individual, symptoms of hyperosmolar coma may develop over the course of a few days or weeks.
Hyperosmolar Coma Treatment and Complications
Hyperosmolar coma is a serious medical condition requiring immediate treatment, which may include intravenous administration of insulin and fluids to stabilize blood glucose levels. Potassium and fluids may also be given intravenously in order to restore hydration and electrolytes. The mortality rate associated with hyperosmolar coma is relatively high, since most patients who suffer this adverse event have a pre-existing condition. Complications possibly resulting from hyperosmolar coma include shock, blood clots and swelling of the brain, also known as a cerebral edema. Unfortunately, an estimated 2-15% of diabetic patients will suffer from at least one episode of diabetic coma in their lifetime as a result of severe hyperglycemia. Individuals at greatest risk for hyperosmolar coma are those who have recently experienced a stroke or heart attack.
Research Linking Risperdal to Hyperosmolar Coma
According to the National Institute of Health, the link between neuroleptics (antipsychotics) and metabolic disturbances has been well documented, and there have been several reports of patients on atypical antipsychotics experiencing a hyperosmolar hyperglycemic state, which is associated with a high risk of complications, coma and death. There is one case study involving a 39-year-old man who was prescribed risperidone to treat schizophrenia-like psychosis of epilepsy and who had never been diagnosed with diabetes. Three years after beginning risperidone treatment, he was admitted to the hospital with symptoms ranging from decreased cognitive ability to involuntary muscular movements. He was diagnosed with Type 2 diabetes and treated in the intensive care unit for hyperosmolar hyperglycemic state.
In April 2004, the U.S. Food and Drug Administration (FDA) issued a warning letter to Risperdal maker Janssen Pharmaceutica, Inc., indicating that a “Dear Healthcare Provider” letter disseminated by the drug company in November 2003, was “false or misleading […] because it fails to disclose the additional information relating to hyperglycemia and diabetes mellitus to the approved product labeling (PI), [and] minimizes the risk of hyperglycemia-related adverse events, which in extreme cases is associated with adverse events including ketoacidosis, hyperosmolar coma and death.” In light of this case study and FDA warning, it is advised that at-risk patients receiving antipsychotic therapy undergo diabetes screening to avoid dangerous side effects like hyperosmolar coma.