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Seroquel Lawsuits Filed Over Diabetes Risk
| April 13, 2007. By Heidi Turner |
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Wilmington,DE: A class action lawsuit has been filed in Florida on behalf of patients who took Seroquel, claiming that the manufacturer AstraZeneca knew about the risk of diabetes but failed to properly warn doctors or patients. The lawsuit further claims that AstraZeneca promoted Seroquel for off-label uses.
According to data released at a medical conference, patients who took Seroquel had 3.34 times more incidents of diabetes as patients on other medications such as haldoperidol.
Plaintiffs are seeking statutory, exemplary, and punitive awards as well as medical monitoring funds to pay for patients who took Seroquel to have tests for diabetes and other disorders.
In November 2006, the FDA Division of Drug Marketing, Advertising, and Communications sent a letter to AstraZeneca regarding their Seroquel sales materials. The FDA found that one of the sales aids was "false or misleading because it minimizes the risk of hyperglycemia and diabetes mellitus and fails to communicate important information regarding neuroleptic malignant syndrome, tardive dyskinesia, and the bolded cataracts precaution." The letter went on to say that the material was a cause of public health concern because it minimized the risks associated with taking Seroquel.
Furthermore, the warning letter stated that AstraZeneca's claim that the percentage of diabetes-related events is very rare (<0.01%) was misleading because adverse event reporting by patients and medical professionals is voluntary and therefore it is not feasible to get an accurate percentage of adverse diabetes-related events. The FDA also warned AstraZeneca that it omitted important information, including information that some of the adverse effects of Seroquel, such as NMS, are potentially fatal. The FDA requested that AstraZeneca respond to their warning letter by November 30, 2006, and remove all sales aids that violated FDA regulations.
Seroquel, an antipsychotic approved by the FDA in 1997, is used to control symptoms of schizophrenia including hallucinations, social withdrawal, delusions, and thought disorder. It is also used in some cases to treat the manic periods of bipolar disorder. Seroquel works by affecting neurotransmitter receptors.
Side Effects
Seroquel is known generically as quetiapine. Common side effects of Seroquel include agitation, constipation, back pain, stomach pain, weight gain, indigestion, dizziness, drowsiness, and dry mouth. If any of these side effects are persistent or bothersome contact a doctor to determine your options. Some side effects of Seroquel are severe and require immediate medical attention. Those side effects include severe allergic reactions, altered mental abilities, high blood sugar, irregular heartbeat, tremors, vision changes, and unexplained fever.
Seroquel Legal Help If you or a loved one has been diagnosed with diabetes while using Seroquel, please contact a [Seroquel] lawyer who will evaluate your claim at no charge.
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