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FDA Criticizes Seroquel Marketing

Dec 5, 2008 | Parker Waichman LLP

In a letter to AstraZeneca released yesterday, the U.S. Food and Drug Administration (FDA) said in January a company sales representative told a doctor that Seroquel was approved for treating depression.  The physician asked for related information and AstraZeneca sent a mailing summarizing research studies of Seroquel in depression.  Seroquel and Seroquel XR are not approved for treating depression, notes Reuters.    "The representative and the mailing recommended or suggested a use for Seroquel and Seroquel XR that has not been approved by FDA, and thus created a new 'intended use' ... for which the products lack adequate directions," the FDA letter said.

Seroquel, known generically as quetiapine fumarate, was approved by the FDA in 1997 and is prescribed for use two or three times a day by mouth to control the psychotic symptoms of bi-polar disorder and schizophrenia.  Seroquel is also sometimes used "off-label" to treat unapproved conditions, including dementia, autism, and psychotic depression.  

Doctors are free to prescribe approved medications off-label, but drug makers are not allowed to promote such uses.

Reuters reported that the FDA letter indicated that while the AstraZeneca mailing said it did not recommend Seroquel for off-label uses, its disclaimer was "insufficient to mitigate the promotion" of a new use.  The FDA has asked AstraZeneca to cease using any similar promotional material, Reuters said.

AstraZeneca and Seroquel have long been the focus of controversy,  For instance, on August 22, 2003, The Wall Street Journal published an article detailing an abstract from a study on atypical antipsychotic medications, including Seroquel that indicated that people taking these drugs were more likely to develop diabetes than patients taking older medications.  In January 2004, the FDA asked AstraZeneca to include warnings about the risk of hyperglycemia (high blood sugar) and diabetes associated with the use of Seroquel.  The FDA said that in some cases, hyperglycemia has resolved when these drugs were discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.

In 2006, the FDA warned that Seroquel and other atypical antipsychotics had been associated with an increased risk of death when used to treat dementia.  Seroquel was never approved to treat dementia, and this constitutes another "off-label" use of the drug.  

In November 2006, the FDA issued AstraZeneca a warning letter alleging that some of the company’s promotional material for Seroquel contained “false or misleading” information.  According to the FDA, AstraZeneca failed to adequately detail the risks of hyperglycemia and diabetes and omitted important data about neuroleptic malignant syndrome and other relevant conditions associated with Seroquel.  The promotional piece mentioned in the letter was a fact sheet about Seroquel distributed to doctors along with the drug's FDA-approved product label.

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