Seroquel Lawsuits Add Up

Dover, DEOver 350 lawsuits were filed in Delaware last month against the maker of Seroquel. That is more than has been filed in the state in the past two years, which began against AstraZeneca Pharmaceuticals after the FDA ordered a change in Seroquel's label, to warn users about an increased risk of diabetes.

One lawyer estimates that defending Seroquel could cost its maker $10 billion. According to one report, there were almost 7,100 Seroquel cases in the federal multidistrict litigation (MDL). Additionally, there are 1,291 Seroquel claims in New Jersey.

In response to concerns about Seroquel, a study is being conducted in Fort Lauderdale, Florida to determine the safety and usefulness of Seroquel in patients with acute bipolar mania. The study will examine both men and women ages 18-65.

Meanwhile, a study conducted by Medco Health Inc., the biggest prescription benefit manager in the U.S., has found that antipsychotic drug use in children has almost doubled. This includes Seroquel, which is approved to treat schizophrenia and bipolar disorder in adults but not in children.

AstraZeneca Pharmaceuticals L.P., is also in trouble for how it marketed the drug. The company disclosed in its 2006 annual report that the Philadelphia U.S. Attorney's Office is investigating "allegations that the company promoted Seroquel of non-indicated (off-label) uses." A warning letter was sent to AstraZeneca's director of promotional regulatory affairs on November 16, 2006. The letter raised the FDA's concerns that AstraZeneca was minimizing the risks associated with Seroquel in its promotional material.

In addition to diabetes, Seroquel has been linked to pancreatitis, an inflammation of the pancreas, hyperglycemia, and Neuroleptic Malignant Syndrome, a potentially fatal syndrome with symptoms that include irregular heartbeat, fever, and stiff muscles. It may also increase the risk of death in seniors who have dementia-related mental problems, a condition that Seroquel has not been approved to treat.

Seroquel, known generically as quetiapine fumarate, is an atypical anti-psychotic drug used to treat symptoms schizophrenia including delusions, hallucinations, social withdrawal, and thought disorder. The drug has also been prescribed to treat acute bipolar mania, severe anxiety, and agitation. The FDA approved Seroquel in 1997.