Risperdal – FDA/Manufacturer Warn of Increased Risk of Diabetes and Stroke

Important Notice: Risperdal has not been the subject of a recall. Questions about prescription, treatment, and health concerns should be discussed with consulting physicians. Patients should never stop taking their medicine without first consulting their physician.

Risperdal (also known as risperidone ) is a popular antipsychotic drug administered for treatment of schizophrenia and bipolar disorder. Risperdal is a member of a new class of drugs called "atypical" antipsychotics. Other "atypical" antipsychotic drugs include Clozaril, Seroquel , Geodon, and Abilify. The drug Risperdal and other drugs in its class are thought to work by balancing the levels of serotonin and dopamine, two natural chemical messengers of the brain.

Risperdal is prescribed to more than 10 million people worldwide and generates about $2.1 billion in annual sales for Janssen.

FDA Requests Label Change Regarding Risperdal and Diabetes. In 2003, the US Food and Drug Administration sent a letter to the manufacturer requesting additional information be placed on the Risperdal label, warning about a possible Risperdal-diabetes link. A similar request was made to five other manufacturers of new antipsychotic medications.

The FDA letter recommended patients using Risperdal and other "atypical" antipsychotics be monitored for blood-sugar abnormalities, especially if they have risk factors such as obesity and a family history of diabetes.

Janssen complied with the FDA's request, in November 2003, adding a warning to the label. However, according to recent news reports, the FDA determined that the company's promotional materials still minimized the risk of strokes, diabetes and other potentially fatal complications.

In response to the FDA's directive, the manufacturer issued a two page letter to healthcare providers clarify the risks of Risperdal. The letter, in part, states that:

"Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics, including Risperdal...Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control.

Patients with risk factors for diabetes mellitus (eg, obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug."

Diabetes is a condition in which the body is unable to produce insulin needed to process sugar normally, and is one of the leading causes of death and disability in the United States. In addition to diabetes, Risperdal may also cause other elevated blood sugar related complications such as hyperglycemia (elevated blood sugar), pancreatitis, diabetic ketoacidosis (DKA), diabetic coma, and death.
Diabetic Symptoms. Diabetes warning signs include:
  • Abnormal thirst and a dry mouth
  • Nausea or vomiting
  • Extreme fatigue or lack of energy
  • Constant hunger
  • Slow-healing wounds
  • Recurrent infections
  • Blurred vision

If you are diabetic and take Risperdal or experience any Risperdal side effects, you should consult a qualified doctor immediately.

Risperdal Linked to Stroke. In April 2003, the manufacturer of Risperdal sent a letter to healthcare providers warning them of important labeling changes. The updated label information warns health care providers of an increased incidence of cerebrovascular adverse events, including stroke and death, in elderly patients with dementia. The warning is based on the results of four clinical trials. Janssen emphasizes that that, like all other antipsychotics, Risperdal is not indicated for the treatment of dementia as it has not been shown to be safe or effective in the treatment of patients with dementia-related psychosis.
If you have experienced side effects after using Risperdal, please complete the ONLINE FORM.