November 16, 2006: FDA Issues Warning on Misleading Seroquel Material
The U.S. Food and Drug Administration (FDA) sent a letter to Seroquel manufacturer AstraZeneca requesting that it immediately cease the dissemination of promotional materials found to be false or misleading. According to the FDA, the material in question minimizes the risk of hyperglycemia and diabetes mellitus associated with Seroquel use, and omits important information about other medical conditions. Click here to read the FDA letter [PDF].
July 13, 2006: Mass-Tort Designation Sought for Antipsychotic Drug Lawsuits
In a Middlesex County (New Jersey) court, 235 claims have been filed against the manufacturers of the antipsychotic drugs Risperdal, Seroquel, and Zyprexa. A superior court judge has asked the New Jersey Supreme Court to combine litigation into a single mass tort. The drugs at issue have been allegedly linked to the occurrence of harmful medical conditions, including diabetes.
April, 2006: FDA Alert - Seroquel Use in Older Patients
The FDA issued an alert announcing its findings that older patients treated with atypical antipsychotics (such as Seroquel) for dementia had a higher chance for death than patients who did not take the medicine. The FDA further stated that treatment of dementia with atypical antipsychotics is not an approved use, and has asked the manufacturers of these medicines to change their labels to include this important information. Click here to read this alert and other information about Seroquel.
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