Label Changes for:

Dostinex (cabergoline) Tablets

August 2011

Changes have been made to the WARNINGS sections of the safety label.

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

 

August 2011 

 

WARNINGS

Fibrotic Complications
Cardiac Valvulopathy
  • A multi-country, retrospective cohort study using general practice records and record linkage systems in the UK, Italy and the Netherlands was conducted to assess the association between new use of dopamine agonists including cabergoline (n = 27,812) for Parkinson’s disease and hyperprolactinemia and cardiac valvular regurgitation (CVR), other fibroses, and other cardiopulmonary events over a maximum of 12 years of follow up. In this study…

 

July 2011 

 

CONTRAINDICATIONS

  • History of cardiac valvular disorders, as suggested by anatomical evidence of valvulopathy of any valve, determined by pre-treatment evaluation including echocardiographic demonstration of valve leaflet thickening, valve restriction, or mixed valve restriction-stenosis. (See WARNINGS)

WARNINGS

Fibrotic Complications
Cardiac Valvulopathy
  • All patients should undergo a cardiovascular evaluation, including echocardiogram to assess the potential presence of valvular disease. If valvular.....
  • Following treatment initiation, clinical and diagnostic monitoring (for example.....
  • The recommended frequency of routine echocardiographic monitoring is.....
Extracardiac Fibrotic Reactions sub-subsection
  • moved from the PRECAUTIONS section and revised
  • Postmarketing cases of pleural, pericardial, and retroperitoneal fibrosis have been reported following administration.....
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