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EMEA...EMEA Recommends Warnings / Ergot-derived Dopamine Agonists, Europed Dopamine

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Old 06-27-2008, 07:36 AM   #1
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Default EMEA...EMEA Recommends Warnings / Ergot-derived Dopamine Agonists, Europed Dopamine

EMEA Recommends New Warnings And Contraindications For Ergot-derived Dopamine Agonists, Europe

27 Jun 2008

The European Medicines Agency has recommended updating the product information for ergot-derived dopamine agonists with new warnings and contraindications in relation to the risk of fibrosis.

Ergot-derived dopamine agonists are mainly used to treat Parkinson's disease. The class comprises bromocriptine, cabergoline, dihydroergocryptine, lisuride and pergolide, all five of which are authorised at the level of the Member States.

At its June 2008 meeting, the Agency's Committee for Medicinal Products for Human Use (CHMP) finalised a review of the safety of ergot-derived dopamine agonists in relation to the risk of fibrosis (the formation of fibrous tissue in some body structures), particularly cardiac fibrosis, associated with their chronic use.

The development of the symptoms of fibrosis is a known side effect of ergot-derived dopamine agonists. However, the CHMP has reviewed new scientific data showing an increased risk of fibrosis in patients receiving ergot-derived dopamine agonists as chronic treatment, suggesting that fibrosis can start to develop far before the occurrence of symptoms.

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