Label Changes for:

Mirapex (pramipexole dihydrochloride)

July 2012

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – July 2012

 

WARNINGS AND PRECAUTIONS

Impulse Control/Compulsive Behaviors
  • Case reports and the results of a cross-sectional study suggest that patients can experience intense urges to gamble, increased sexual urges, intense urges to spend money uncontrollably, binge eating, and/or other intense urges and the inability to control these urges while taking one or more of the medications, including Mirapex, that increase central dopaminergic tone and that are generally used for the treatment of Parkinson’s disease. In some cases, although not all, these urges were reported to have stopped when the dose was reduced or the medication was discontinued. Because patients may not recognize these behaviors as abnormal it is important for prescribers to specifically ask patients or their caregivers about the development of new or increased gambling urges, sexual urges, uncontrolled spending or other urges while being treated with Mirapex. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking Mirapex

ADVERSE REACTIONS

Post Marketing Experience
  • pruritis, compulsive shopping and vomiting

 

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