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Seroquel Diabetes Warning
On September 11, 2003, the FDA informed all manufacturers of atypical antipsychotic drugs such as Seroquel that due to an increasing prevalence of diabetes-related illnesses associated with this class of drugs, all labeling must bear the following language in the Warnings section:
Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes rnellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse events is not completely understood, However, epidemiologic studies suggest an increased risk of treatment emergent hyperglycemia-related adverse events in patients treated with atypical antipsychotics. Precise risk estimates for hyperglycemia-related adverse events in patients treated with atypical antipsychotics are not available.
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 (e.g., obesity, Family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during 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.
Still, AstraZeneca did not send a "Dear Doctor" letter until January, 2004 to advise prescribing doctors - many of whom were prescribing Seroquel for off label uses - of the new warning. Making matters worse, the "Dear Doctor" letter it did send was misleading. In April, 2004, Seroquel's manufacturer was forced to send out a revised "Dear Doctor" letter due to the fact that the first one was misleading because it downplayed the need to continually monitor a patient's blood sugar levels while on the drug.
Our Seroquel diabetes class action lawyers are investigating potential Seroquel lawsuits on behalf of victims and their families who suffered from diabetes as the result of the use of Seroquel, including claims involiving the duty to warn about the diabetes risks associated with Seroquel. If you or a loved one have experienced a severe side effect from Seroquel, call one of our Seroquel class action lawyers at 1-800-553-6000 or click here for a free Internet consultation.
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