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U.S. Department of Health and Human Services

Safety

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Seroquel (quetiapine fumarate) Tablets, Seroquel (quetiapine fumarate) XR

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – July 2011

 

Summary View

5 WARNINGS AND PRECAUTIONS

5.12 QT Prolongation
  • In clinical trials quetiapine was not associated with a persistent increase in QT intervals. However, the QT effect.....
5.21 Use in Patients with Concomitant Illness
  • see changes to section 5.12

6 ADVERSE REACTIONS

6.3 Postmarketing Experience
  • hypothermia added

7 DRUG INTERACTIONS

  • The use of quetiapine should be avoided in combination with drugs known to increase QT interval, and caution should be exercised when quetiapine is used in combination with drugs known to cause electrolyte imbalance

8 USE IN SPECIAL POPULATIONS

8.1 Pregnancy
8.3 Nursing Mothers
 

MEDICATION GUIDE

  • bullet added to 'tell your healthcare provider if' ..... for "abnormal heart beats or rhythm"
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