Label Changes for:

Mirapex (pramipexole dihydrochloride) Tablets and Mirapex ER (pramipexole dihydrochloride) Extended Release Tablets

March 2013

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) –

 

 

March 2013

ADVERSE REACTIONS

Post Marketing Experience
  • ...inappropriate antidiuretic hormone secretion (SIADH)

 

 

August 2012

 

WARNINGS AND PRECAUTIONS

Retinal Pathology
  • Human Data: A two-year open-label, randomized, parallel-group safety study of retinal deterioration and vision compared Mirapex tablets and immediate-release Ropinirole…

 

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