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FDA: Drugmaker Suggested Off Label Use for Seroquel

Seroquel is indicated for the treatment of both depressive episodes associated with bipolar disorder acute manic episodes associated with bipolar I disorder as either monotherapy or adjunct therapy to lithium or divalproex as well for the treatment of schizophrenia. Seroquel XR is indicated for the treatment of schizophrenia.

The FDA issued a warning letter to AstraZeneca, Seroquel's maker, claiming that a company sales rep recommended or suggested to a healthcare professional an off-label use for Seroquel and Seroquel XR.

The comments, according to the agency, created a new "intended use" for Seroquel and Seroquel XR for which the products lack adequate directions. The FDA said that in addition to the reps oral comments, AstraZeneca sent a mailing to the same health care professional regarding unapproved uses for Seroquel. The agency said these promotional activities and materials misbrand the drugs in violation of the Federal Food, Drug, and Cosmetic Act.

Source here.

Full post as published by A Georgia Lawyer on December 08, 2008 (boomark / email).