Label Changes for:

Prozac Weekly (fluoxetine hydrochloride)

April 2011

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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

 

6 ADVERSE REACTIONS

6.2 Other Reactions
  • added balance disorder, bruxism, gynecological bleeding, hypotension
  • added alopecia, dysuria, micturition disorder
  • added depersonalization

 

8 USE IN SPECIAL POPULATIONS

8.1 Pregnancy

Treatment of Pregnant Women during the First Trimester

  • added information about the potential risk of cardiovascular defects in infants exposed during first trimester

 

MEDICATION GUIDE (new)

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