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
