A look at the dangerous side effects and off label use of Seroquel.
What is Seroquel?
Seroquel, a drug in the class of drugs known as "atypical antipsychotics," is approved to treat symptoms of schizophrenia and bipolar disorders such as manic depression. Seroquel, which was approved by the FDA in 1997, generates nearly $4.45 billion in sales every year for the British-Swedish pharmaceutical giant Astra Zeneca. Thousands of patients have sued AstraZeneca on allegations that taking the drug lead to diabetes, and/or pancreatitis. Lawsuits also allege that AstraZeneca marketed and promoted Seroquel for "off label" use beyond what the FDA had approved it for. Finally, AstraZeneca has been accused of offering incentives to physicians and other medical professionals in an effort to increase prescriptions of Seroquel.
What is "Off-Label" Use?
When the Food and Drug Administration (FDA) approves a drug, it is to treat a specific condition, an "indication." While physicians are permitted by the FDA to prescribe drugs for other than their approved indication, drug companies are not allowed to market the drug for use other than the approved indication. The practice of prescribing drugs for an unapproved condition is called off-label use. Seroquel and many other antipsychotics are frequently prescribed to treat dementia in nursing home patients, despite the fact that the drugs are not approved by the FDA for treating dementia. Seroquel is also used off-label to treat such conditions as obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), restless legs syndrome (RLS), autism, alcoholism, depression, Tourette syndrome, and as a sedative for those with anxiety disorders or sleep disorders.
Side Effects of Seroquel
The most common side effects of Seroquel are dry mouth, drowsiness, increases in cholesterol and triglycerides, upset stomach, constipation, dizziness, a sudden drop in blood pressure upon standing, weight gain, increased appetite, fatigue, increases in blood sugar, stuffy nose, and difficulty sleeping. Seroquel is known to increase suicidal thoughts. One serious side effect reported with Seroquel is tardive dyskinesia (TD)—uncontrollable movements of the face, tongue, or other parts of the body. A study published in the Journal of the American Medical Association found that after only 11 weeks, children taking Seroquel gained an average of 13.5 pounds. The study raised concerns about the long term health problems children might be exposed to, such as diabetes.
Seroquel Lawsuits and Settlements
In 2008, it was reported that more than 8,700 lawsuits had been filed against AstraZeneca in federal and state courts, alleging the drug led to pancreatitis, diabetes and other personal injuries. A report released by the British Government in 2009 suggested antipsychotic drugs like Seroquel and Abilify could be responsible for 1,800 deaths and 1,620 strokes each year in the United Kingdom. AstraZeneca has spent of $600 million in defense costs for Seroquel Lawsuits. If you have been diagnosed with diabetes or otherwise suffered harm from taking Seroquel, you may be entitled to compensation. Contact an defective products attorney with experience in pharmaceutical litigation – most offer a free consultation. Due to a statute of limitations, you only have a limited amount of time to file a lawsuit, so do not hesitate in contacting an attorney.