New warnings for ergots

The EMEA has recommended new warnings and contraindications for ergot-derived dopamine agonists due to the risk of fibrosis associated with chronic use.

Ergot derivatives are used for a variety of indications, but mainly to treat Parkinson’s disease. The drug class comprises pergolide, bromocriptine and cabergoline.

The development of the symptoms of fibrosis is a known adverse effect of ergot-derived dopamine agonists. However, review of new scientific data has shown an increased risk of fibrosis in patients receiving ergot-derived dopamine agonists during chronic treatment, suggesting that fibrosis can develop before the occurrence of symptoms.

The risk of fibrosis is not equally established for all ergots, and their product information will be updated accordingly.

New warnings for cabergoline and pergolide:

  • Patients must be monitored for signs of fibrosis on echocardiography before treatment is started and regularly during treatment.
  • A reduction of the maximum dose to 3mg/day.
  • Inclusion of cardiac fibrosis as a very common side effect.

Cabergoline + pergolide are already contraindicated in patients with evidence of valve problems and restricted to second-line use in Parkinson’s disease.

New contraindication and warning for bromocriptine:

  • Use is contraindicated in patients with pre-existing valve problems.
  • Restriction of a maximum dose to 30mg/day.

In addition, ergot derivatives should not be given to patients who have had fibrosis in the heart, lungs, or abdomen. The absence of cardiac fibrosis should be verified before treatment is started

Further information: MHRA

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