The EMEA has recommended revising the product information for ergot-derived dopamine agonists with new warnings and contraindications relating to the risk of fibrosis.

The EMEA says that its Committee for Medicinal Products for Human use (CHMP) has reviewed the safety of ergot-derived dopamine agonists with regard to the risk of fibrosis, especially cardiac fibrosis, in association with their chronic use. The agency explains that the development of fibrosis symptoms is a known adverse effect of ergot-derived dopamine agonists. However, new data have shown an increased risk of fibrosis in ...

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