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Unsafe Drugs :: Seroquel


In 1997, Seroquel was approved by the FDA to treat individuals suffering from schizophrenia and bipolar disorder. However, it was often prescribed to treat "off-label" disorders as well like autism and dementia thanks in large part to the manufacturer, AstraZeneca (NYSE: AZN), promoting these unapproved, "off-label" uses.

Beginning in 2003, the FDA began to take notice of reports of hyperglycemia and diabetes occuring at an alarming rate in patients that had been prescribed Seroquel. Subsequently, in 2004, the FDA required AstraZeneca to add a label warning of these serious side effects.

In 2005, Seroquel was finally required to carry a black box warning, the FDA's highest such safety warning, after a clinical study found that when Seroquel was prescribed for dementia, which is not an approved use of the drug, the mortality rate is considerably higher in patients that are given Seroquel than those patients given a placebo.

The reason why this is a concern is that AstraZeneca was using false and misleading promotional material leading to the drug being used for conditions for which it was not intended nor approved by the FDA. In fact, the FDA issued a warning letter to AstraZeneca asserting that the company not only used misleading marketing material, but also failed to make doctors and patients aware of the side effects.

As mentioned above, diabetes and hyperglycemia are the two leading side effects associated with this drug whether it was prescribed for approved uses or not. But there is also the risk of heart failure or sudden death, especially when taken for "off-label" uses. We believe that AstraZeneca only exacerbated the problem by marketing this defective and unsafe drug for conditions it was never supposed to treat.

Their defective drug not only harmed the people for whom it was intended, but also thousands of others due to their deceptive and outlandish marketing. We intend to hold them accountable for their negligent actions. 

Unsafe drug cases are complex and costly to litigate.  Experienced representation is essential, and that is exactly what we help provide.  If you believe you or a loved one suffered a serious complication as a result of using Seroquel, please fill out the form below for a free evaluation.
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