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The FDA issued a Safety Communication yesterday warning of the potential risk of heart failure with use of Mirapex (pramipexole), a prescription drug used to treat the signs and symptoms of Parkinsons disease and restless leg syndrome. Mirapex is also sometimes used off-label as a treatment for cluster headache and to counteract problems with sexual dysfunction experience by some users of selective serotonin reuptake inhibitor (SSRI) antidepressants.

The FDA is continuing studies to clarify the risk of heart failure and will warn the public when that information is available.

In the meantime, patients should continue to take Mirapex as directed by their doctors. However, if any of the following side effects are experienced, you should consult your doctor immediately:

  • Shortness of breath
  • Swelling of the feet, ankles, legs or abdomen
  • Fatigue and weakness
  • Rapid or irregular heartbeat
  • Chest pain
  • Persistent cough or wheezing with blood-tinged phlegm

In addition to contacting your doctor, if you experience any of these side effects, you should submit an Adverse Event Report to the FDA to assist in their efforts to determine the safety of Mirapex.

Manufactured by Boehringer-Ingelheim, Mirapex went off label in 2012 and is now available as a generic drug.

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