The FDA's DDMAC issued a warning letter to AstraZeneca asserting 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 healthcare 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.
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.
According to the FDA letter, in January 2008, a sales representative from AstraZeneca made an unsolicited sales call to a physician. The representative stated that Seroquel was approved for treatment of major depressive disorder (MDD).
This representation was not made in response to a request for such information by the physician. As a result of this representation, the physician requested that AstraZeneca provide written information to support the claim that Seroquel has been approved for the treatment of MDD. In response to this request, AstraZeneca sent the physician a mailing containing information about Seroquel and Seroquel XR's use for MDD, and included summaries of eight clinical trials with referenced citations. This mailing was not the result of an unsolicited request by the physician, but rather was prompted by the sales representative's statements, the FDA letter states.
Seroquel and Seroquel XR are not FDA approved for the treatment of MDD. The oral statements made by the sales representative and the information provided in the January mailing was misleading and suggest a new "intended use" for Seroquel and Seroquel XR, according to the FDA letter.
The FDA concluded that the oral statements made, and information provided by AstraZeneca and its representative recommend or suggest a use for Seroquel and Seroquel XR that has not been approved by FDA, and thus misbrand Seroquel and Seroquel XR in violation of the FFDCA Act. DDMAC has requested that AstraZeneca immediately cease the dissemination of “violative” promotional materials for Seroquel and Seroquel XR.