SEROQUEL INJURIES AND WARNINGS

• Seroquel can cause diabetes and diabetes-related complications including coma and death
• Seroquel can cause death by cardiac events or infections in elderly dementia patients
• Research has shown significant risks associated with all atypical antipsychotics
• FDA-mandated warnings have been added to the Seroquel label

SEROQUEL INJURIES

Seroquel has been linked to an increased risk of diabetes, diabetes-related illnesses, and death.

The reported injuries vary depending on the type of patient:

Schizophrenia, bipolar disorder, & non-dementia patients: diabetes, hyperglycemia, ketoacidosis, pancreatitis, death

Elderly dementia patients: death by cardiac events (heart failure, sudden death) or infections (mostly pneumonia)

Hundreds if not thousands of cases of serious and sometimes fatal illnesses have been attributed to Seroquel use. That number will undoubtedly continue to rise as long as Seroquel is on the market.

In a recent study, atypical antipsychotics such as Seroquel were found to cause diabetes 50% more often than older antipsychotic drugs. Ketoacidosis, or diabetic coma, when associated with Seroquel use, reportedly ends up fatal in about 50% of the cases.

Diabetes is a devastating, life long disease for which there is no cure. Diabetes is the number one cause of blindness, kidney failure and non-traumatic limb amputation in the U.S. and the number two cause of cardiovascular problems. Diabetics are 2 to 4 times more likely to suffer from strokes and heart disease deaths than non-diabetics. Overall, diabetics are twice as likely to die as non-diabetics of the same age.

Our law firm represents people who have suffered serious injuries as a result of taking Seroquel or Zyprexa. Contact our offices for a free consultation with one of our pharmaceutical attorneys.

SEROQUEL RESEARCH

Beginning in 2001, research results began to surface revealing high risks associated with the use of atypical antipsychotics, such as Seroquel and Zyprexa. Studies showed that:

Elderly patients taking atypical antipsychotics for dementia were more likely to die from cardiac events or infections; and

Patients taking atypical antipsychotics for schizophrenia or bipolar disorder showed an increased risk of developing diabetes, hyperglycemia, ketoacidosis, and pancreatitis and had a greater risk of death.

If you or someone you know has taken Seroquel or Zyprexa and suffered serious side effects, contact our offices for a free case review by our pharmaceutical attorneys.

SEROQUEL WARNINGS

Diabetes and diabetes-related illnesses

In 2003, the FDA ordered the drug companies to revise the labels of their atypical antipsychotic medications to include a warning about the link to diabetes and diabetes-related illnesses. Following is an excerpt from the mandatory warning:

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 ... 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.

In January of 2004, AstraZeneca changed the Seroquel label to include the mandatory warning and issued a "Dear Doctor" letter informing physicians about the label changes.

In Japan and Europe, the regulatory agencies required clear strong diabetes warnings on Seroquel labeling. This would be equivalent to the "black box" warning in the U.S. The black box warning is the strongest warning available and is prominently displayed in a box on page 1 of the Prescribing Information. In the U.S., the FDA did not order a black box warning.

Elderly dementia patients

In April 2005, the FDA issued a Safety Alert to warn the public about the dangers of using antipsychotics, such as Seroquel and Zyprexa in dementia patients. Following is an excerpt:

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.

AstraZeneca subsequently changed their label to include a black box warning about the dangerous side effects of using Seroquel in dementia patients.

For many people, the warnings came too late. If you or someone you know has suffered serious injury as a result of taking Seroquel or Zyprexa, submit your information and our pharmaceutical attorneys will review your case for free.