Important Notice: Seroquel 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.

Seroquel (quetiapine) is a popular antipsychotic drug administered for treatment of schizophrenia and bipolar disorder. Seroquel is a member of a new class of drugs called "atypical" antipsychotics. Other "atypical" antipsychotic drugs include Clozaril, Risperdal, Zyprexa, Geodon, and Abilify. The drug Seroquel 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.

A number of studies have linked Seroquel and other "atypical antipsychotic" drugs to an increased risk of a number of serious side effects, including diabetes, hyperglycemia (high blood sugar), ketoacidosis, pancreatitis, coma, and death. The FDA has also issued a public health advisory concerning increased mortality rate among elderly patients treated for dementia.

If you or a loved one have experienced side effects after using Seroquel, please complete our ONLINE FORM for a confidential review of your claim at no cost or obligation.

__________________________________________________________________

Below are the FDA Public Health Advisory Concerning Atypical Antipsychotics in Elderly Patients, the FDA Alert concerning Seroquel, and the manufacturer's "Dear Doctor" Letter.

FDA PUBLIC HEALTH ADVISORY: Deaths with Antipsychotics in Elderly Patients with Behavioral Disturbances (Issued April 11, 2005)

The Food and Drug Administration has determined that the treatment of behavioral disorders in elderly patients with dementia with atypical (second generation) antipsychotic medications is associated with increased mortality. Of a total of seventeen placebo controlled trials performed with olanzapine (Zyprexa), aripiprazole (Abilify), risperidone (Risperdal), or quetiapine (Seroquel) in elderly demented patients with behavioral disorders, fifteen showed numerical increases in mortality in the drug-treated group compared to the placebo-treated patients. These studies enrolled a total of 5106 patients, and several analyses have demonstrated an approximately 1.6-1.7 fold increase in mortality in these studies. Examination of the specific causes of these deaths revealed that most were either due to heart related events (e.g., heart failure, sudden death) or infections (mostly pneumonia).

The atypical antipsychotics fall into three drug classes based on their chemical structure. Because the increase in mortality was seen with atypical antipsychotic medications in all three chemical classes, the Agency has concluded that the effect is probably related to the common pharmacologic effects of all atypical antipsychotic medications, including those that have not been systematically studied in the dementia population. In addition to the drugs that were studied, the atypical antipsychotic medications include clozapine (Clozaril) and ziprasidone (Geodon). All of tvhe atypical antipsychotics are approved for the treatment of schizophrenia. None, however, is approved for the treatment of behavioral disorders in patients with dementia. Because of these findings, the Agency will ask the manufacturers of these drugs to include a Boxed Warning in their labeling describing this risk and noting that these drugs are not approved for this indication. Symbyax, a combination product containing olanzapine and fluoxetine, approved for the treatment of depressive episodes associated with bipolar disorder, will also be included in the request.

The Agency is also considering adding a similar warning to the labeling for older antipsychotic medications because the limited data available suggest a similar increase in mortality for these drugs.

FDA ALERT ON SEROQUEL (ISSUED 4/2005):

This is a summary of the most important information about Seroquel. For details, talk to your healthcare professional.

FDA ALERT [04/2005] –Seroquel is a type of medicine called an atypical antipsychotic. FDA has found that older patients treated with atypical antipsychotics for dementia had a higher chance for death than patients who did not take the medicine. This is not an approved use.

FDA has asked the companies that make these medicines to change their labels to include this important information.

This information reflects FDA’s current analysis of all available data concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

What is Seroquel?

• Seroquel is in a class of medications called atypical antipsychotics. Antipsychotic medicines are used to treat symptoms of schizophrenia that may include hearing voices, seeing things, or sensing things that are not there, mistaken beliefs or unusual suspiciousness.
• Seroquel may be used alone or with lithium or divalproex to treat acute manic episodes in adults who have a condition called Bipolar I disorder. Bipolar disorder is a mental illness that causes extreme mood swings.

What are The Risks?

The following are the major potential risks and side effects of Seroquel therapy. However, this list is not complete.

Seroquel and other antipsychotic medications can cause serious problems such as:

• A life-threatening nervous system problem called neuroleptic malignant syndrome (NMS). NMS can cause a high fever, stiff muscles, sweating, a fast or irregular heart beat, change in blood pressure, and confusion. NMS can affect your kidneys. NMS is a medical emergency. Call your healthcare professional right away if you experience these symptoms.
• A movement problem called tardive dyskinesia (TD). Call your healthcare professional right away if you get muscle movements that cannot be stopped.
• High blood sugar and diabetes. Patients with diabetes or who have a higher chance for diabetes should have their blood sugar checked
• Other serious side effects may include low blood pressure seen as dizziness, increased heart beat and possibly fainting, cataracts, seizures, low thyroid, elevated cholesterol or triglycerides, liver problems, persistent erection, increase or decrease in body temperature, and difficulty swallowing.
• The most common side effects include headache, agitation, dry mouth, constipation, pain, vomiting, upset stomach and weight gain.

What Should I Tell My Healthcare Professional?

Before you start taking Seroquel, tell your healthcare professional if you:

• have or had heart problems
• have or had cataracts
• have a thyroid disorder
• have high cholesterol or triglycerides
• have or had seizures.
• have or had diabetes or increased blood sugar
• have or had liver disease
• are trying to become pregnant, are already pregnant, or are breast-feeding.
• drink alcohol

Are There Any Interactions With Drugs or Foods?

Because certain other medications can interact with Seroquel, review all medications that you are taking with your health care professional, including those that you take without a prescription.

Your healthcare professional may have to adjust your dose or watch you more closely if you take the following medications:

• blood pressure medicines
• levodopa and medicines called dopamine agonists
• phenytoin
• thioridazine
• antifungal or antibiotic medicines such as ketoconazole, itraconazole, fluconazole and erythromycin
• lorazepam

Avoid drinking alcohol while taking Seroquel.

Is There Anything Else I Need to Know?

• Dizziness, and sometimes fainting, caused by a drop in blood pressure may happen with Seroquel, especially when you first start taking this medicine or when the dose is increased.
• Seroquel may impair judgment, thinking, or motor skills. You should be careful in operating machinery, including automobiles, until you know how Seroquel affects you.
• It is important to avoid overheating and dehydration while taking Seroquel. Seroquel may make it harder to lower your body temperature.
  

Seroquel FDA Approved 1997
Patient Information Sheet Revised 05/2005

 

APRIL 2004 DEAR DOCTOR LETTER FROM THE MANUFACTURER:

IMPORTANT DRUG INFORMATION
April 22, 2004

Dear Health Care Provider,
AstraZeneca Pharmaceuticals LP would like to inform you of important labeling changes regarding SEROQUEL® (quetiapine fumarate). The FDA has asked all manufacturers of atypical antipsychotic medications, including AstraZeneca, to add a Warnings statement describing the increased risk of hyperglycemia and diabetes in patients taking these medications, including SEROQUEL. Accordingly, the SEROQUEL Prescribing Information has been updated with the addition of the following information:

WARNINGS
Hyperglycemia and Diabetes Mellitus
Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics, including Seroquel. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus 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, epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-related adverse events in patients treated with the 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 (eg, 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.