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boxed warning WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death [see Warnings and Precautions (5.1) ] . Quetiapine extended-release tablets are not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ]. Suicidal Thoughts and Behavior Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.2) ] . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.2) ] Quetiapine extended-release tablets are not approved for use in pediatric patients under ten years of age [see Use in Specific Populations (8.4) ]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Quetiapine extended-release tablets are not approved for elderly patients with dementia-related psychosis. ( 5.1 ) Suicidal Thoughts and Behaviors Increased risk of suicidal thoughts and behavior in children, adolescents and young adults taking antidepressants. ( 5.2 ) Monitor for worsening and emergence of suicidal thoughts and behaviors. ( 5.2 )
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warnings and cautions table <table width="100%" cellspacing="10" cellpadding="10"><caption>Table 5: Percentage of Adult Patients with Shifts in Total Cholesterol, Triglycerides, LDL- Cholesterol and HDL-Cholesterol from Baseline to Clinically Significant Levels by Indication</caption><col width="20%"/><col width="20%"/><col width="30%"/><col width="15%"/><col width="15%"/><tbody><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Laboratory</content></paragraph><paragraph><content styleCode="bold">Analyte</content></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Indication</content></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Treatment Arm</content></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">N</content></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Patients n (%)</content></paragraph></td></tr><tr><td rowspan="8" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Total Cholesterol</paragraph><paragraph>≥240 mg/dL</paragraph></td><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Schizophrenia <footnote ID="tbl5-ftn1">6 weeks duration</footnote></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-release tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>718</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>67 (9%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>232</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>21 (9%)</paragraph></td></tr><tr><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Bipolar Depression <footnote ID="tbl5-ftn2">8 weeks duration</footnote></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-release tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>85</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>6 (7%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td><paragraph>106</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>3 (3%)</paragraph></td></tr><tr><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Bipolar Mania <footnote ID="tbl5-ftn3">3 weeks duration</footnote></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-release tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>128</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>9 (7%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>134</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>5 (4%)</paragraph></td></tr><tr><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Major Depressive Disorder (Adjunct Therapy) <footnoteRef IDREF="tbl5-ftn1"/></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-release tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>420</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>67 (16%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>213</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>15 (7%)</paragraph></td></tr><tr><td rowspan="8" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Triglycerides</paragraph><paragraph>≥200 mg/dL</paragraph></td><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Schizophrenia <footnoteRef IDREF="tbl5-ftn1"/></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-release tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>659</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>118 (18%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>214</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>11 (5%)</paragraph></td></tr><tr><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Bipolar Depression <footnoteRef IDREF="tbl5-ftn2"/></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-release tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>84</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>7 (8%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>93</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>7 (8%)</paragraph></td></tr><tr><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Bipolar Mania <footnoteRef IDREF="tbl5-ftn3"/></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-release tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>102</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>15 (15%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>125</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>8 (6%)</paragraph></td></tr><tr><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Major Depressive</paragraph><paragraph>Disorder (Adjunct Therapy) <footnoteRef IDREF="tbl5-ftn1"/></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-release tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>458</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>75 (16%)</paragraph></td></tr><tr><td><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>223</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>18 (8%)</paragraph></td></tr><tr><td rowspan="8" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>LDL-Cholesterol</paragraph><paragraph>≥160 mg/dL</paragraph></td><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Schizophrenia <footnoteRef IDREF="tbl5-ftn1"/></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-release tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>691</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>47 (7%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>227</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>17 (8%)</paragraph></td></tr><tr><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Bipolar Depression <footnoteRef IDREF="tbl5-ftn2"/></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-release tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>86</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>3 (4%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>104</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>2 (2%)</paragraph></td></tr><tr><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule">Bipolar Mania <footnoteRef IDREF="tbl5-ftn3"/></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-release tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>125</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>5 (4%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>135</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>2 (2%)</paragraph></td></tr><tr><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule"><paragraph>Major Depressive Disorder (Adjunct</paragraph><paragraph>Therapy) <footnoteRef IDREF="tbl5-ftn1"/></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-release tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>457</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>51 (11%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>219</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>21 (10%)</paragraph></td></tr><tr><td rowspan="8" align="left" styleCode="Botrule Lrule Rrule Toprule"><paragraph>HDL-Cholesterol</paragraph><paragraph>≤40 mg/dL</paragraph></td><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule"><paragraph>Schizophrenia <footnoteRef IDREF="tbl5-ftn1"/></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-release tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>600</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>87 (15%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>195</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>23 (12%)</paragraph></td></tr><tr><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule"><paragraph>Bipolar Depression <footnoteRef IDREF="tbl5-ftn2"/></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-release</paragraph><paragraph>tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>78</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>7 (9%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>83</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>6 (7%)</paragraph></td></tr><tr><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule"><paragraph>Bipolar Mania <footnoteRef IDREF="tbl5-ftn3"/></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-release tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>100</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>19 (19%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>115</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>15 (13%)</paragraph></td></tr><tr><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule"><paragraph>Major Depressive Disorder (Adjunct</paragraph><paragraph>Therapy) <footnoteRef IDREF="tbl5-ftn1"/></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-release tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>470</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>34 (7%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>230</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>19 (8%)</paragraph></td></tr></tbody></table>
warnings and cautions table <table width="70%" cellspacing="10" cellpadding="10"><caption>Table 6: Percentage of Patients with Shifts in Total Cholesterol, Triglycerides, LDL- Cholesterol and HDL-Cholesterol from Baseline to Clinically Significant Levels in MDD Adjunctive Therapy Trials by Dose</caption><col width="20%"/><col width="40%"/><col width="15%"/><col width="25%"/><tbody><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Laboratory Analyte</content></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Treatment Arm <footnote ID="tbl6-ftn1">6 weeks duration</footnote></content></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">N</content></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Patients n (%)</content></paragraph></td></tr><tr><td rowspan="3" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Cholesterol≥240</paragraph><paragraph>mg/dL</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-release</paragraph><paragraph>tablets 150 mg</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>223</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>41 (18%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-release</paragraph><paragraph>tablets 300 mg</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>197</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>26 (13%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>213</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>15 (7%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Triglycerides</paragraph><paragraph>≥200 mg/dL</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-release</paragraph><paragraph>tablets 150 mg</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>232</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>36 (16%)</paragraph></td></tr><tr><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"/><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-release</paragraph><paragraph>tablets 300 mg</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>226</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>39 (17%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>223</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>18 (8%)</paragraph></td></tr><tr><td rowspan="3" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>LDL-Cholesterol</paragraph><paragraph>≥160 mg/dL</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-release</paragraph><paragraph>tablets 150 mg</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>242</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>29 (12%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-release</paragraph><paragraph>tablets 300 mg</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>215</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>22 (10%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>219</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>21 (10%)</paragraph></td></tr><tr><td rowspan="3" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>HDL-Cholesterol</paragraph><paragraph>≤40 mg/dL</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-release</paragraph><paragraph>tablets 150 mg</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>238</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>14 (6%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-release</paragraph><paragraph>tablets 300 mg</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>232</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>20 (9%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>230</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>19 (8% </paragraph></td></tr></tbody></table>
warnings and cautions table <table width="80%" cellspacing="10" cellpadding="10"><caption>Table 7: Percentage of Children and Adolescents with Shifts in Total Cholesterol, Triglycerides, LDL-Cholesterol and HDL-Cholesterol from Baseline to Clinically Significant Levels by Indication</caption><col width="25%"/><col width="20%"/><col width="30%"/><col width="10%"/><col width="15%"/><tbody><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Laboratory Analyte</content></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Indication</content></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Treatment Arm</content></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">N</content></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Patients n (%)</content></paragraph></td></tr><tr><td rowspan="4" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Total Cholesterol≥</paragraph><paragraph>200 mg/dL</paragraph></td><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Schizophrenia <footnote ID="tbl7-ftn1">13 to 17 years, 6 weeks duration</footnote></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>107</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>13 (12%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>56</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>1 (2%)</paragraph></td></tr><tr><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Bipolar Mania <footnote ID="tbl7-ftn2">10 to 17 years, 3 weeks duration</footnote></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>159</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>16 (10%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>66</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>2 (3%)</paragraph></td></tr><tr><td rowspan="4" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Triglycerides≥150 mg/dL</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Schizophrenia <footnoteRef IDREF="tbl7-ftn1"/></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>103</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>17 (17%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"/><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>51</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>4 (8%)</paragraph></td></tr><tr><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Bipolar Mania <footnoteRef IDREF="tbl7-ftn2"/></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>149</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>32 (22%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>60</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>8 (13%)</paragraph></td></tr><tr><td rowspan="4" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>LDL-Cholesterol≥</paragraph><paragraph>130 mg/dL</paragraph></td><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Schizophrenia <footnoteRef IDREF="tbl7-ftn1"/></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>112</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>4 (4%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>60</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>1 (2%)</paragraph></td></tr><tr><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Bipolar Mania <footnoteRef IDREF="tbl7-ftn2"/></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>169</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>13 (8%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>74</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>4 (5%)</paragraph></td></tr><tr><td rowspan="4" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>HDL-Cholesterol≤ 40</paragraph><paragraph>mg/dL</paragraph></td><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Schizophrenia <footnoteRef IDREF="tbl7-ftn1"/></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>104</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>16 (15%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>54</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>10 (19%)</paragraph></td></tr><tr><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Bipolar Mania <footnoteRef IDREF="tbl7-ftn2"/></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>154</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>16 (10%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>61</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>4 (7%)</paragraph></td></tr></tbody></table>
warnings and cautions table <table width="80%" cellspacing="10" cellpadding="10"><caption>Table 8: Percentage of Patients with Weight Gain ≥7% of Body Weight (Adults) by Indication</caption><col width="20%"/><col width="25%"/><col width="30%"/><col width="10%"/><col width="15%"/><tbody><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Vital sign</content></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Indication</content></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Treatment Arm</content></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">N</content></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Patients n (%)</content></paragraph></td></tr><tr><td rowspan="8" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Weight gain</content></paragraph><paragraph><content styleCode="bold"> ≥7% of body</content></paragraph><paragraph><content styleCode="bold">weight</content></paragraph></td><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Schizophrenia <footnote ID="tbl8-ftn1">6 weeks duration</footnote></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-</paragraph><paragraph>release tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>907</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>90 (10%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>299</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>16 (5%)</paragraph></td></tr><tr><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Bipolar Mania <footnote ID="tbl8-ftn2">3 weeks duration</footnote></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-</paragraph><paragraph>release tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>138</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>7 (5%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>150</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>0 (0%)</paragraph></td></tr><tr><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Bipolar Depression <footnote ID="tbl8-ftn3">8 weeks duration</footnote></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-</paragraph><paragraph>release tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>110</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>9 (8%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>125</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>1 (1%)</paragraph></td></tr><tr><td rowspan="2" align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Major Depressive Disorder (Adjunctive</paragraph><paragraph>Therapy) <footnoteRef IDREF="tbl8-ftn1"/></paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Quetiapine extended-</paragraph><paragraph>release tablets</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>616</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>32 (5%)</paragraph></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Placebo</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>302</paragraph></td><td align="left" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>5 (2%)</paragraph></td></tr></tbody></table>
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adverse reactions 6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Increased mortality in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.1) ] Suicidal thoughts and behaviors in adolescents and young adults [see Warnings and Precautions (5.2) ] Cerebrovascular adverse reactions, including stroke in elderly patients with dementia- related psychosis [see Warnings and Precautions (5.3) ] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions (5.4) ] Metabolic changes (hyperglycemia, dyslipidemia, weight gain) [see Warnings and Precautions (5.5) ] Tardive dyskinesia [see Warnings and Precautions (5.6) ] Hypotension [see Warnings and Precautions (5.7) ] Falls [see Warnings and Precautions (5.8) ] Increases in blood pressure (children and adolescents) [see Warnings and Precautions (5.9) ] Leukopenia, neutropenia and agranulocytosis [see Warnings and Precautions (5.10) ] Cataracts [see Warnings and Precautions (5.11) ] QT Prolongation [see Warnings and Precautions (5.12) ] Seizures [see Warnings and Precautions (5.13) ] Hypothyroidism [see Warnings and Precautions (5.14) ] Hyperprolactinemia [see Warnings and Precautions (5.15) ] Potential for cognitive and motor impairment [see Warnings and Precautions (5.16) ] Body temperature regulation [see Warnings and Precautions (5.17) ] Dysphagia [see Warnings and Precautions (5.18) ] Discontinuation Syndrome [see Warnings and Precautions (5.19) ] Anticholinergic (antimuscarinic) Effects [see Warnings and Precautions (5.20) ] Most common adverse reactions (incidence ≥5% and twice placebo): Adults: somnolence, dry mouth, constipation, dizziness, increased appetite, dyspepsia, weight gain, fatigue, dysarthria, and nasal congestion ( 6.1 ) Children and Adolescents: somnolence, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, tachycardia, weight increased ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ACI Healthcare USA, Inc. at 1-888-802-1213 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.2 Postmarketing Experience The following adverse reactions were identified during post approval use of quetiapine tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions reported since market introduction which were temporally related to quetiapine therapy include anaphylactic reaction, cardiomyopathy, drug reaction with eosinophilia and systemic symptoms (DRESS), hyponatremia, myocarditis, nocturnal enuresis, pancreatitis, retrograde amnesia, rhabdomyolysis, syndrome of inappropriate antidiuretic hormone secretion (SIADH), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN),decreased platelet count, serious liver reactions (including hepatitis, liver necrosis, and hepatic failure), agranulocytosis, intestinal obstruction, ileus, colon ischemia, sleep apnea, and urinary retention.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.