Janssen Pharmaceutica, Inc. recently sent a letter out to physicians which advised physicians of important labeling changes regarding its antipsychotic drug, Risperdal ® (risperidone).
Risperdal was FDA approved for the treatment of schizophrenia. Janssen Pharmaceutica, Inc. advised the physicians that the FDA has asked all manufacturers of atypical antipsychotic medications, including Janssen Pharmaceutica, Inc. to add a Warnings statement describing the increased risk of hyperglycemia and diabetes in patients taking these medications, including Risperdal.
Accordingly, the Warning section of the Risperdal Prescribing Information was updated to warn 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.
It also advised that 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.
Janssen Pharmaceutica, Inc. acknowledged that patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing, and that while in some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.
If your physician prescribed Risperdal for you the treatment of schizophrenia, and if you have been diagnosed with Type II Diabetes Mellitus, call us to discuss your potential claim.
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