Ohio Seroquel Lawyer
The FDA approved a new drug application for Zeneca Pharmaceuticals and Astra Zeneca (“Zeneca’) in 1997. The medical community recognizes Seroquel as an effective treatment for patients suffering from schizophrenia; however, the risks of diabetes and increased levels of blood sugar outweigh its benefit for the vast majority of patients receiving the medication.
Clinical studies have demonstrated a connection between Seroquel and increased blood sugar and diabetes. However, the company has been slow to adopt a proper warning to reflect the risk of diabetes. In January, 2004, the FDA asked manufactures of this class of drugs to add a warnings statement describing the increased risk of hyperglycemia and diabetes in patients taking these medications. The warning mentions a possible connection but downplays the data indicating that background rates and precise adverse event data complicate any conclusion or causal evidence. As a result, the warning has not affected growth, and in 2006, Seroquel's (change to Seroquel )earned $3.4 billion in sales.
Indeed, the Japanese Seroquel label includes a more prominent warning, specifically stating that there is a link between diabetes and the use of Seroquel. The United States label, however, does not unequivocally reflect this known problem, which is misleading and deceptive to consumers and physicians.
“Off Label Marketing”
When the FDA approves a drug it also approves the label, which lists the indications, adverse events, warnings, and patients for which the drug can be prescribed. Once a drug is approved to treat one condition, it is within a physician’s judgment whether to prescribe it for others if they think it will be effective. This provision is geared to not restrict prescribing drugs where it is clear that the risk of not giving the drug outweighs the use. Off label uses should be rare because there is insufficient safety data to support the use outside the approved class. By law, drug companies are not allowed to influence physicians to prescribe a drug for indications other than those listed on the label.
In this case, the Federal Government, State Attorney Generals, Patient Advocacy Groups and Medical Associations have all taken steps to discover information and prosecute the company for engaging in illegal “off label” marketing and promotion. Specifically, it has been alleged that Zeneca actively encouraged physicians to prescribe the medication to patients, with non severe psychiatric conditions, and conditions unapproved by the FDA in order to expand the market for higher revenue. As a result, many patients were put at an unreasonable risk and suffered injuries that should have been avoided.
If you or a loved one have suffered complications due to the prescription of Seroquel, please contact The Lyon Firm for help. We are handling these cases on a co-counsel arrangement with the prominent Miller Firm in Virginia.
