Wednesday, July 20, 2011

Seroquel: Label Change because of Heart Risks

From the FDA and other sources:

Seroquel is a drug that is widely prescribed. Also known as Quetiapine, it is used to treat either schizophrenia or bipolar disorder. In those with bipolar it is used for depressive episodes, acute manic episodes associated with bipolar I disorder, and maintenance treatment of bipolar I disorder (as adjunct therapy to lithium or divalproex). 

Last week, this label change:


Elderly patients with dementia-related psychosis treated with antipsychotic
drugs are at an increased risk of death. Analyses of seventeen placebocontrolled trials (modal duration of 10 weeks) largely in patients taking
atypical antipsychotic drugs, revealed a risk of death in drug-treated
patients of between 1.6 to 1.7 times the risk of  death in placebo-treated
patients. Over the course of a typical  10-week controlled trial, the rate of
death in drug-treated patients was about 4.5%, compared to a rate of about
2.6% in the placebo group. Although the causes of death were varied, most
of the deaths appeared to be either cardiovascular (e.g., heart failure,
sudden death) or infectious (e.g., pneumonia) in nature.  Observational
studies suggest that, similar to atypical antipsychotic drugs, treatment with
conventional antipsychotic drugs may increase mortality. The extent to
which the findings of increased mortality in observational studies may be
attributed to the antipsychotic drug as opposed to some characteristic(s) of
the patients is not clear.  SEROQUEL (quetiapine) is not approved for the
treatment of patients with dementia-related psychosis [see  Warnings and
Precautions (5.1)]