Label Changes for:
Mirapex (pramipexole dihydrochloride) Tablets and Mirapex ER (pramipexole dihydrochloride) Extended Release Tablets
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) –
Post Marketing Experience
- ...inappropriate antidiuretic hormone secretion (SIADH)
WARNINGS AND PRECAUTIONS
- Human Data: A two-year open-label, randomized, parallel-group safety study of retinal deterioration and vision compared Mirapex tablets and immediate-release Ropinirole…