August 23, 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 the continued use of misleading TV advertisements for Seroquel XR, which appear to violate many principles governing appropriate DTC advertising.
When we first complained about these ads in January, Seroquel was approved for schizophrenia and for psychosis associated with bipolar disorder. According to the FDA web site and AstraZeneca’s Seroquel web site. Bipolar psychosis is associated with the manic phase of bipolar disorder. The Seroquel ad campaign in January talked about the use of Seroquel for bipolar disorder, but was focused on depression, not the psychosis associated with the manic phase of bipolar disorder. The theme of the TV ads as well as similar print ads was that “It’s easy to feel like you’re fading into the background.” That’s a description of depression, not psychosis or mania.
In December the FDA approved Seroquel XR as an add-on to an anti-depressant for the treatment of refractory depression, but that information was not yet available on the Seroquel or FDA web sites in January when this ad campaign was in full force. The same TV ads that were widely shown in January have continued this summer. Unfortunately, the ads are still misleading, although for somewhat different reasons than in January.
The current TV ads still talk about bipolar disorder while visually portraying depression. 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.
When describing suicide risk, the ad 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 that has been approved for use with antidepressants, but is not itself an antidepressant!
Seroquel ads should specify that Seroquel is an anti-psychotic that is only approved for the treatment of depression that has not responded to anti-depressants and should only be used in conjunction with 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 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
In addition, when the ads provide warnings about risks, there is so much distracting information that the typical viewer is unable to cognitively process the risk information.
We are very disappointed that in the 8 months since our letter, DDMAC has not ordered a halt to these advertisements nor required corrective ads by the sponsoring company. It seems that DDMAC assumed that FDA’s approval of Seroquel for major depression would resolve the misleading problems with the ads. As pointed out in this letter, however, the ads continue to be misleading because Seroquel is not an anti-depressant and it is only approved for depression that has not responded to anti-depressants and when used in conjunction with anti-depressants – not on its own. To protect the public health, DDMAC should immediately scrutinize all Seroquel ads and order a halt to all those that purport to advertise its use for bipolar disorder but instead describe depressive symptoms in the ads, as well as all ads that do not specify the limited conditions under which Seroquel was approved for major depression.
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
cc: The Honorable Rosa DeLauro
The Honorable Charles Grassley