David Baxter PhD
Late Founder
Quetiapine Approved for Bipolar Monotherapy
By Sandra Kiume, World of Psychology
The FDA has granted approval to Astra Zeneca for quetiapine (Seroquel) as monotherapy for bipolar disorders. Quetiapine, which is in the atypical antipsychotic drug class also used to treat schizophrenia, had been approved for the treatment of mania in bipolar I patients. Recent studies, including bipolar I and II and rapid cycling patients, indicate some effectiveness in bipolar depression as well. Researchers found statistically significant improvements in overall quality of life, and in symptoms of bipolar depression. The FDA’s decision was based largely on a one eight-week study of 1,045 patients.
The official FDA label wording:
The FDA label warns of “Increased Mortality in Elderly Patients with Dementia-Related Psychosis” (1.7 times more). Seroquel is not approved for use in pediatric patients, either. There’s a warning of increased suicidality related to antidepressants - 4% in a meta analysis of 4400 patients taking antidepressants of various types, including SSRIs.
Quetiapine is not among the drugs generally known as antidepressants, such as SSRIs. Other drugs such as the anticonvulsant lamotrigine are considered antidepressants in bipolar depression, but do not have the same suicidality risk attributed to SSRI drugs. Labelling groups of chemicals “antidepressant” and “antiepileptic” often disregards major differences in composition, and uses. Antidepressant drugs include SSRIs, SNRIs, SSNRIs, novel anticonvulsants, stimulants, etc. Now quetiapine, from the atypical antipsychotic family that includes risperidal, olanzapine, and the increasingly popular aripiprazole (Abilify).
Atypical antipsychotics are touted as reducing the risk of tardive dyskinesia, a severe movement disorder, but the FDA label admits, ” Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown.” Long-term use should be carefully evaluated.
Astra Zeneca has filed for the same single dose pill monotherapy approval in Canada and Europe.
Read more from the FDA
Psychiatric monograph
Reviews and info
Drug Bank profile
By Sandra Kiume, World of Psychology
The FDA has granted approval to Astra Zeneca for quetiapine (Seroquel) as monotherapy for bipolar disorders. Quetiapine, which is in the atypical antipsychotic drug class also used to treat schizophrenia, had been approved for the treatment of mania in bipolar I patients. Recent studies, including bipolar I and II and rapid cycling patients, indicate some effectiveness in bipolar depression as well. Researchers found statistically significant improvements in overall quality of life, and in symptoms of bipolar depression. The FDA’s decision was based largely on a one eight-week study of 1,045 patients.
The official FDA label wording:
SEROQUEL is indicated for the treatment of both:
The approved formulation is a once a day pill of 300 mg. Reducing a medication regimen to one pill a day would be more convenient and improve compliance. • depressive episodes associated with bipolar disorder
• acute manic episodes associated with bipolar I disorder as either monotherapy or adjunct therapy to lithium or divalproex.
• acute manic episodes associated with bipolar I disorder as either monotherapy or adjunct therapy to lithium or divalproex.
The FDA label warns of “Increased Mortality in Elderly Patients with Dementia-Related Psychosis” (1.7 times more). Seroquel is not approved for use in pediatric patients, either. There’s a warning of increased suicidality related to antidepressants - 4% in a meta analysis of 4400 patients taking antidepressants of various types, including SSRIs.
Quetiapine is not among the drugs generally known as antidepressants, such as SSRIs. Other drugs such as the anticonvulsant lamotrigine are considered antidepressants in bipolar depression, but do not have the same suicidality risk attributed to SSRI drugs. Labelling groups of chemicals “antidepressant” and “antiepileptic” often disregards major differences in composition, and uses. Antidepressant drugs include SSRIs, SNRIs, SSNRIs, novel anticonvulsants, stimulants, etc. Now quetiapine, from the atypical antipsychotic family that includes risperidal, olanzapine, and the increasingly popular aripiprazole (Abilify).
Atypical antipsychotics are touted as reducing the risk of tardive dyskinesia, a severe movement disorder, but the FDA label admits, ” Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown.” Long-term use should be carefully evaluated.
Astra Zeneca has filed for the same single dose pill monotherapy approval in Canada and Europe.
Read more from the FDA
Psychiatric monograph
Reviews and info
Drug Bank profile