(N=90)
 Quetiapine 400 mg

(N=95)
 Quetiapine 600 mg

(N=98)
 All Quetiapine

(N=193)
 
n
 %
 n
 %
 n
 %
 n
 %
 
Parkinsonism†
 1
 1.1
 2
 2.1
 1
 1.0
 3
 1.6
 
Akathisia‡
 0
 0.0
 1
 1.0
 1
 1.0
 2
 1.0
 
Other extrapyramidal event§
 0
 0.0
 1
 1.1
 1
 1.0
 2
 1.0
 

Children and Adolescents: Safety and effectiveness of SEROQUEL XR have not been established in pediatric patients and SEROQUEL XR is not approved for patients under the age of 18 years. In acute placebo-controlled trials in children and adolescent patients with schizophrenia (6-week duration) or bipolar mania (3-week duration), the incidence of increased appetite was 7.6% for SEROQUEL compared to 2.4% for placebo. In a 26-week open-label study that enrolled patients from the above two pediatric trials, the incidence of increased appetite was 10% for SEROQUEL.

6.2 Vital Signs and Laboratory Values
Hyperglycemia, hyperlipidemia, weight gain and orthostatic hypotension have been reported with quetiapine. Increases in blood pressure have also been reported with quetiapine in children and adolescents [see Warnings and Precautions (5.4, 5.5, 5.6, 5.8 and 5.9)].

Laboratory Changes:

Neutrophil Counts

In three-arm SEROQUEL XR placebo-controlled monotherapy clinical trials, among patients with a baseline neutrophil count ≥ 1.5 x 109/L, the incidence of at least one occurrence of neutrophil count <1.5 x 109/L was 1.5% in patients treated with SEROQUEL XR and 1.5% for SEROQUEL, compared to 0.8% in placebo-treated patients.

In placebo-controlled monotherapy clinical trials involving 3368 patients on quetiapine fumarate and 1515 on placebo, the incidence of at least one occurrence of neutrophil count <1.0 x 109/L among patients with a normal baseline neutrophil count and at least one available follow up laboratory measurement was 0.3% (10/2967) in patients treated with quetiapine, compared to 0.1% (2/1349) in patients treated with placebo. Patients with a pre-existing low WBC or a history of drug induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and should discontinue SEROQUEL XR at the first sign of a decline in WBC in absence of other causative factors [see Warnings and Precautions (5.10)].

ECG Changes:

2.5% of SEROQUEL XR patients, and 2.3% of placebo patients, had tachycardia (>120 bpm) at any time during the trials. SEROQUEL XR was associated with a mean increase in heart rate, assessed by ECG, of 6.3 beats per minute compared to a mean increase of 0.5 beats per minute for placebo. This is consistent with the rates for SEROQUEL. The incidence of adverse reactions of tachycardia was 1.9% for SEROQUEL XR compared to 0.5% for placebo. SEROQUEL use was associated with a mean increase in heart rate, assessed by ECG, of 7 beats per minute compared to a mean increase of 1 beat per minute among placebo patients. The slight tendency for tachycardia may be re