FDA Denies Seroquel Citizen Petition, AstraZeneca Files Suit

On March 7, the Food and Drug Administration (FDA) denied two citizen petitions filed by AstraZeneca September 9 that requested the FDA to require generic versions of its Seroquel antipsychotic (quetiapine) come with warnings about high blood sugar and suicidal tendencies. The FDA denied the requests "without comment," leaving AstraZeneca with no information about the FDA's intentions regarding the generic.

On March 12, AstraZeneca responded by filing a complaint and motion for summary judgment, saying that FDA's nonresponse violated the Administrative Procedure Act and should be set aside. AstraZeneca is asking for an injunction enjoining the FDA from granting final approval for generic versions of Seroquel or its extended form, Seroquel XR. AstraZeneca has argued that the omission of the information in the generic drug's labeling would make a generic product less safe and effective than the branded products. Prior to this action, a generic form of Seroquel was expected to be approved as early as late this month.

Concerns have recently been raised about the use of Seroquel as a sleep aid in soldiers returning from Iraq and Afghanistan. Read more about it in Psychiatric News, here.

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FDA Orders New Warning on Seroquel Label

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The FDA has required a new warning on the label of the atypical antipsychotic Seroquel (quetiapine) cautioning doctors about potential prolongation of the QT interval that may occur when above-recommended amounts of Seroquel are combined with specific drugs. The warning advised against the use of Seroquel in combination with certain antiarrhythmics, antipsychotics, antibiotics, and other drugs, prompted by notice of 17 post-marketing cases of induced QT prolongation. Seroquel's prior labeling had warned of the heart arrhythmia risk but hadn't mentioned other drugs that could interact with the antipsychotic. The revised label also raises caution about use by the elderly and people with heart disease.

Even without the new warning, Seroquel's label is many pages long. Read about recent concerns regarding "overwarning" about adverse events on drug labels in Psychiatric News at http://pn.psychiatryonline.org/content/46/14/2.2.full.