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FDA Warning

in this section: FDA Warning Letter 11/06


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Warning about Hyperglycemia and Atypical Antipsychotic Drugs - Including Seroquel

FDA has asked manufacturers of all atypical antipsychotic drugs to add a new warning to the drugs' labels about the increased risk of hyperglycemia and diabetes. Atypical antipsychotics include: Clozaril ® (clozapine), Risperdal ® (risperidone), Zyprexa ® (olanzepine), Seroquel ® (quetiapine), Geodon ® (ziprasidone), and Abilify ® (aripiprazole).

Epidemiologic studies suggest that the risk of hyperglycemia and diabetes is increased in patients taking Clozaril, Risperdal, Zyprexa and Seroquel, although the relationship isn't completely understood. In some cases, the hyperglycemia was extreme and associated with ketoacidosis or hyperosmolar coma or death. Geodon and Abilify weren't marketed at the time the study was conducted.

For some patients, the hyperglycemia resolved when the drug was discontinued, but others required continuing treatment for their diabetes even after they stopped taking the drug.

The warning recommends that patients with diabetes who are started on atypical antipsychotics be monitored regularly for worsening of glucose control.

Patients starting on these drugs who have diabetes risk factors, such as obesity or a family history of diabetes, should have fasting blood glucose testing at the start of treatment and periodically thereafter.

And all patients treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia, such as excessive thirst, excessive appetite, frequent urination, or weakness. If they develop symptoms of hyperglycemia while on these drugs, they should have a fasting blood glucose test.

If you've taken Seroquel and developed diabetes, diabetic conditions like diabetic ketoacidosis, or pancreatitis , the Seroquel lawyers at Weitz & Luxenberg can help you understand your legal options. Fill out the form below to take your first step.

Weitz & Luxenberg is no longer accepting Seroquel cases.


see also:

FDA Warning Letter 11/06 AstraZeneca's Seroquel Given FDA Letter Over "Misleading" Material
AstraZeneca's Seroquel Given FDA Letter On "Misleading" Promo Material

Children and Psychiatric Drugs Controversy Surrounds Giving a Child Psychiatric Drugs Like Seroquel
Giving drugs like Seroquel to a child labeled bipolar is now common

News & Warnings Get news and warnings from a Seroquel (quetiapine fumarate) Attorney
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