January 14, 2010
Director, Division of Drug Marketing, Advertising, and Communications
10903 New Hampshire Ave.
Building 51, Room 3200
Silver Spring, MD 20993-0002
Dear Mr. Abrams,
We are writing to express strong concerns about advertisements for Seroquel XR, which are highly misleading and appear to violate many principles governing appropriate DTC advertising.
According to the FDA web site and AstraZeneca’s Seroquel web site, Seroquel is approved for schizophrenia and for psychosis associated with bipolar disorder. Bipolar psychosis is associated with the manic phase of bipolar disorder. In addition, according to an AstraZeneca press release, in December the FDA approved Seroquel XR as an add-on to an anti-depressant for the treatment of refractory depression.
The current Seroquel ad campaign is focused on depression, not psychosis associated with the manic phase of bipolar disorder; in fact, the people in the TV ads look the opposite of manic. The theme of the TV ads and a recent Time magazine ad is that “It’s easy to feel like you’re fading into the background.” That’s a description of depression, not psychosis or mania.
The TV and Time ads talk about “bipolar depression,” rather than “bipolar disorder,” and when describing suicide risk it says that Seroquel, “like other anti-depressants,” can increase the risk of suicide. That implies that Seroquel is an anti-depressant, when in fact it is an atypical antipsychotic, not an antidepressant!
To be consistent with the pre-December FDA approval, Seroquel ads should focus on reducing psychosis from schizophrenia or the manic phase of bipolar disorder. To be consistent with the FDA’s December approval decision, any ads for Seroquel for depression should specify that Seroquel is only approved for use for refractory depression and only if used in conjunction with an anti-depressant. These ads are therefore misleading whether you consider the old FDA approval decision or the new one.
These ads are clearly misleading; they should specify that Seroquel is an anti-psychotic that is only approved for the treatment of depression when used in conjunction with other anti-depressants. The warnings about suicide should specify that there is a risk of suicide from anti-depressants and potentially an additional risk from Seroquel XR.
The rapid weight gain and metabolic changes associated with Seroquel and other atypical antipsychotics can cause heart disease and diabetes. The Time ad certainly understates the risk of rapid and dramatic weight gain by saying “weight gain has been reported.” The TV ads do not adequately convey the risks of Seroquel, which in addition to metabolic changes can cause sudden cardiac death.
These drugs are already widely used off-label and these ads seek to promote expanded inappropriate usage. The current ads violate three of the four major principles underlying current FDA guidance on DTC advertising:
- Making unsubstantiated claims
- Rationalization of side effects
- Inappropriate expansion to the wrong population
We believe that DDMAC should order a halt to these advertisements and require corrective ads by the sponsoring company. We have specified only two ads in this letter; of course, DDMAC should scrutinize all the ads for Seroquel and respond accordingly.
Diana Zuckerman Ph.D., President
National Research Center for Women & Families
Steven E. Nissen M.D. MACC
Department of Cardiovascular Medicine
9500 Euclid Ave.
Cleveland, Ohio 44195